<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03752359</url>
  </required_header>
  <id_info>
    <org_study_id>UEL1700756-1/2018</org_study_id>
    <nct_id>NCT03752359</nct_id>
  </id_info>
  <brief_title>Whey Protein Supplementation and Resistance Training in Older Women With Sarcopenic Obesity.</brief_title>
  <official_title>Effect of Whey Protein Supplementation Combined With Resistance Training on Body Composition, Muscular Strength, Functional Capacity, and Plasma-metabolism Biomarkers in Older Women With Sarcopenic Obesity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Estadual de Londrina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Conselho Nacional de Desenvolvimento Científico e Tecnológico</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Coordination for the Improvement of Higher Education Personnel</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universidade Estadual de Londrina</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of the present study was to investigate the effects of whey protein&#xD;
      following resistance training on body composition, muscular strength, functional capacity,&#xD;
      and plasma-metabolism biomarkers in older women with sarcopenic obesity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This two-arm randomized, double-blind, placebo-controlled design was carried out over a&#xD;
      period of 16 weeks. At the beginning and end of the experiment, two weeks were allocated for&#xD;
      evaluations consisting of anthropometric (weeks 2 and 16), body composition (weeks 2 and 16),&#xD;
      one repetition maximum tests (weeks 1 and 15), functional capacity tests (weeks 1 and 15),&#xD;
      blood samples (weeks 2 and 16) and dietary intake measurements (weeks 1 and 15). The&#xD;
      anthropometric, body composition, blood samples and dietary intake measurements were carried&#xD;
      out in a temperature-controlled room (22-24 °C), and the RT sessions were conducted at the&#xD;
      university training facility.&#xD;
&#xD;
      Recruitment was carried out through newspapers, radio advertising, and home delivery of&#xD;
      leaflets in the central area and residential neighborhoods. All participants completed health&#xD;
      history and physical activity questionnaires and were included in the study if they met the&#xD;
      following inclusion criteria: 60 years old or more, physically independent, free from cardiac&#xD;
      or orthopedic dysfunction that would prevent them from performing the prescribed exercise or&#xD;
      exercise testing associated with the study, not receiving hormonal replacement therapy, and&#xD;
      completed a previous 8-week RT program. In this study, only women with SO were included. SO&#xD;
      was defined as a body fat mass ≥ 35%(29) combined with appendicular lean soft tissue (ALST)&#xD;
      less than &lt;15.02 kg(30), assessed by dual x-ray energy absorptiometry (DXA). Participants&#xD;
      underwent a diagnostic graded exercise stress test with a 12-lead electrocardiogram reviewed&#xD;
      by a cardiologist and were released with no restrictions for participation in this&#xD;
      investigation.&#xD;
&#xD;
      A blinded researcher was responsible for generating random numbers for participant&#xD;
      allocation. Both groups were submitted to the same RT program and all participants completed&#xD;
      the experiment. Written informed consent was obtained from all participants after a detailed&#xD;
      description of investigation procedures was provided. This investigation was conducted&#xD;
      according to the Declaration of Helsinki and was approved by the local University Ethics&#xD;
      Committee The Shapiro Wilk test was used to test data distribution. Data are presented as&#xD;
      means, standard deviation, and z-score. The student's independent t-test and chi-square test&#xD;
      were used to compare groups regarding the general characteristics and clinical/medical&#xD;
      history (categorical variables). Two-way analysis of variance (ANOVA) for repeated measures&#xD;
      was used to assess between group comparisons. The effect size (ES) was calculated to verify&#xD;
      the magnitude of the differences by Cohen's d, where an ES of 0.20-0.49 was considered as&#xD;
      small, 0.50-0.79 as moderate, and ≥ 0.80 as large(41). The Z-score of the percentage changes&#xD;
      (from pre- to post-training) of the raw data for each parameter was calculated, as well as a&#xD;
      total Z-score, derived from all the components. To verify the differences between groups in&#xD;
      total Z-scores, an independent T test was also applied. For all statistical analyses,&#xD;
      significance was accepted at P &lt; 0.05. The data were analyzed using SPSS software version&#xD;
      20.0 (SPSS, Inc., Chicago, IL, USA).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 13, 2017</start_date>
  <completion_date type="Actual">June 30, 2017</completion_date>
  <primary_completion_date type="Actual">March 17, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in body composition</measure>
    <time_frame>baseline and after 12 weeks</time_frame>
    <description>Whole-body dual-energy X-ray absorptiometry (DXA) (Lunar Prodigy) was used to assess lean mass and fat mass and its segments. The total skeletal muscle mass (SMM) was estimated by the predictive equation proposed by Kim et al. (Kim et al., 2004). The results are presented in kg.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Muscular strength</measure>
    <time_frame>baseline and after 12 weeks</time_frame>
    <description>Maximal dynamic strength was evaluated using the 1RM test assessed on chest press, knee extension, and preacher curl exercises performed in this exact order. Testing for each exercise was preceded by a warm-up set (6-10 repetitions), with approximately 50% of the estimated load used in the first attempt of the 1RM. This warm-up was also used to familiarize the subjects with the testing equipment and lifting technique. The testing procedure was initiated 2 minutes after the warm-up. The subjects were instructed to try to accomplish two repetitions with the imposed load in three attempts in both exercises. The rest period was 3 to 5 min between each attempt, and 5 min between exercises. The 1RM was recorded as the last resistance lifted in which the subject was able to complete only one single maximal execution</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in inflammatory markers</measure>
    <time_frame>baseline and after 12 weeks</time_frame>
    <description>Tumor Necrosis Factor -α (TNF-α) and Interleukin-6 (IL-6) were determined by enzyme-linked immunosorbent assay (ELISA), according to the specifications of the manufacturer and performed in a microplate reader Perkin Elmer, model EnSpire (USA). All samples were determined in duplicate to guarantee the precision of the results. The results are presented in picograms per milliliter (pg/ml).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in C-reactive protein (CRP)</measure>
    <time_frame>baseline and after 12 weeks</time_frame>
    <description>Measurements of serum levels of high-sensitivity CRP were carried out using a biochemical auto-analyzer system (Dimension Max - Siemens Dade Behring) according to established methods in the literature consistent with the manufacturer's recommendations. The results are presented in milligrams per decilitre (mg/dL).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in oxidative stress</measure>
    <time_frame>baseline and after 12 weeks</time_frame>
    <description>For measurements, advanced oxidation protein products (AOPP) were determined in the plasma using a semiautomatic method. AOPP concentrations were expressed as micromoles per liter (μmol/L). Total plasma antioxidant capacity (TRAP) was determined by the chemiluminescence method for the induction time of 2.2 azo-bis (2-amidinopropane) and calibrated with Trolox analogue of vitamin E. TRAP values were expressed in μmol of Trolox.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Total cholesterol</measure>
    <time_frame>baseline and after 12 weeks</time_frame>
    <description>Measurements of serum levels of total cholesterol were determined using a biochemical auto-analyzer system (Dimension Max - Siemens Dade Behring) according to established methods in the literature consistent with the manufacturer's recommendations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in high-density lipoprotein (HDL-C)</measure>
    <time_frame>baseline and after 12 weeks</time_frame>
    <description>Measurements of serum levels of high-density lipoprotein were determined using a biochemical auto-analyzer system (Dimension Max - Siemens Dade Behring) according to established methods in the literature consistent with the manufacturer's recommendations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in triglycerides</measure>
    <time_frame>baseline and after 12 weeks</time_frame>
    <description>Measurements of serum levels of triglycerides were determined using a biochemical auto-analyzer system (Dimension Max - Siemens Dade Behring) according to established methods in the literature consistent with the manufacturer's recommendations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in low-density lipoprotein</measure>
    <time_frame>baseline and after 12 weeks</time_frame>
    <description>For the determination of LDL-c was used the Friedewald equation: LDL-c=TC - (HDL-c + TG / 5).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in glucose</measure>
    <time_frame>baseline and after 12 weeks</time_frame>
    <description>Measurements of serum levels of glucose (GLU) were determined using a biochemical auto-analyzer system (Dimension Max - Siemens Dade Behring).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in insulin</measure>
    <time_frame>baseline and after 12 weeks</time_frame>
    <description>Insulin was determined by the chemiluminescence method (LIASON equipment)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in HOMA-IR</measure>
    <time_frame>baseline and after 12 weeks</time_frame>
    <description>The Homeostasis Assessment Model (HOMA-IR) was calculated by the formula: Insulin fasting (μUI / mL) x Glucose fasting (mmol / L) / 22.5.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in blood pressure</measure>
    <time_frame>baseline and after 12 weeks</time_frame>
    <description>Resting BP assessment was performed using automatic, oscillometric equipment (Omron - 7113). Participants attended the laboratory on three different days and, during each visit, remained seated at rest for 10 min with the cuff of the equipment in place on the right arm. Subsequently, several BP measurements were performed at one-minute intervals in order to obtain three consecutive measurements where the difference in systolic BP (SBP) and diastolic BP (DBP) readings differed by no more than 4 mmHg. The average of the three measurements for each day was averaged across the three visits.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in body mass</measure>
    <time_frame>baseline and after 12 weeks</time_frame>
    <description>Body mass was measured to the nearest 0.1 kg using a calibrated electronic scale, with subjects wearing light workout clothing and no shoes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in height</measure>
    <time_frame>baseline and after 12 weeks</time_frame>
    <description>Height was measured using a stadiometer to the nearest 0.1 cm while subjects were standing without shoes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in body mass index</measure>
    <time_frame>baseline and after 12 weeks</time_frame>
    <description>Body mass index was calculated as the body mass in kilograms divided by the square of the height in meters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in waist circumference</measure>
    <time_frame>baseline and after 12 weeks</time_frame>
    <description>We also collected data on waist circumference (WC), using a flexible and inelastic tape measure. WC was obtained at the midpoint between the last rib and the iliac crest at the time of expiration. Two measurements were used to measure each circumference. In situations in which the difference between the measurements was greater than 0.5 cm a third measurement was performed, with the value of the median being adopted as reference. All measurements were performed by the same evaluator.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in hip circumference</measure>
    <time_frame>baseline and after 12 weeks</time_frame>
    <description>We also collected data on hip circumference, using a flexible and inelastic tape measure. HC was measured in the region of greater perimeter between the waist and the thigh. Two measurements were used to measure each circumference. In situations in which the difference between the measurements was greater than 0.5 cm a third measurement was performed, with the value of the median being adopted as reference. All measurements were performed by the same evaluator.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dietary intake</measure>
    <time_frame>baseline and after 12 weeks</time_frame>
    <description>Food consumption were assessed by the 24-hour dietary recall method applied on two non-consecutive days of the week, with the aid of a photographic record taken during an interview. The homemade measurements of the nutritional values of food and supplementation were converted into grams and milliliters by the online software Virtual Nutri Plus for diet analysis. Some foods were not found in the program database and therefore items were added from food tables.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Body Weight</condition>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>whey protein group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received a dose of 35 grams of whey protein after resistance training (RT). Participants were personally supervised by physical education professionals with substantial RT experience. The sessions were performed 3 times per week on Mondays, Wednesdays, and Fridays, with 3 sets of 08-12 repetition maximums. The RT program was a whole-body program with eight exercises, including: chest press, seated row, triceps push-down, preacher curl, horizontal leg press, knee extension, leg curl and seated calf raise. Participants were afforded a 1 to 2 min rest interval between sets and 2 to 3 min between each exercise. The training load was consistent with the prescribed number of repetitions for the three sets of each exercise.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants received a dose of 35 grams of maltodextrin after resistance training (RT). Participants were personally supervised by physical education professionals with substantial RT experience. The sessions were performed 3 times per week on Mondays, Wednesdays, and Fridays, with 3 sets of 08-12 repetition maximums. The RT program was a whole-body program with eight exercises, including: chest press, seated row, triceps push-down, preacher curl, horizontal leg press, knee extension, leg curl and seated calf raise. Participants were afforded a 1 to 2 min rest interval between sets and 2 to 3 min between each exercise. The training load was consistent with the prescribed number of repetitions for the three sets of each exercise.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>whey protein</intervention_name>
    <description>This two-arm randomized, double-blind, placebo-controlled design was carried out over a period of 16 weeks. At the beginning and end of the experiment, two weeks were allocated for evaluations consisting of anthropometric (weeks 2 and 16), body composition (weeks 2 and 16), one repetition maximum tests (weeks 1 and 15), functional capacity tests (weeks 1 and 15), blood samples (weeks 2 and 16) and dietary intake measurements (weeks 1 and 15). The anthropometric, body composition, blood samples and dietary intake measurements were carried out in a temperature-controlled room (22-24 °C), and the RT sessions were conducted at the university training facility.</description>
    <arm_group_label>whey protein group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>This two-arm randomized, double-blind, placebo-controlled design was carried out over a period of 16 weeks. At the beginning and end of the experiment, two weeks were allocated for evaluations consisting of anthropometric (weeks 2 and 16), body composition (weeks 2 and 16), one repetition maximum tests (weeks 1 and 15), functional capacity tests (weeks 1 and 15), blood samples (weeks 2 and 16) and dietary intake measurements (weeks 1 and 15). The anthropometric, body composition, blood samples and dietary intake measurements were carried out in a temperature-controlled room (22-24 °C), and the RT sessions were conducted at the university training facility.</description>
    <arm_group_label>placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        60 years old or more, physically independent, free from cardiac or orthopedic dysfunction&#xD;
        that would prevent them from performing the prescribed exercise or exercise testing&#xD;
        associated with the study, not receiving hormonal replacement therapy, and completed a&#xD;
        previous 8-week RT program. In this study, only women with SO were included. SO was defined&#xD;
        as a body fat mass ≥ 35% combined with appendicular lean soft tissue (ALST) less than&#xD;
        &lt;15.02 kg, assessed by dual x-ray energy absorptiometry (DXA). Participants underwent a&#xD;
        diagnostic graded exercise stress test with a 12-lead electrocardiogram reviewed by a&#xD;
        cardiologist and were released with no restrictions for participation in this&#xD;
        investigation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        All subjects not participating in 85% of the total sessions of training or withdraw&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Edilson Cyrino, PhD.</last_name>
    <role>Study Director</role>
    <affiliation>Universidade Estadual de Londrina</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hellen Clair Garcez Nabuco</name>
      <address>
        <city>Cuiabá</city>
        <state>Mount</state>
        <zip>78032143</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>American College of Sports Medicine. American College of Sports Medicine position stand. Progression models in resistance training for healthy adults. Med Sci Sports Exerc. 2009 Mar;41(3):687-708. doi: 10.1249/MSS.0b013e3181915670.</citation>
    <PMID>19204579</PMID>
  </reference>
  <reference>
    <citation>Kim J, Heshka S, Gallagher D, Kotler DP, Mayer L, Albu J, Shen W, Freda PU, Heymsfield SB. Intermuscular adipose tissue-free skeletal muscle mass: estimation by dual-energy X-ray absorptiometry in adults. J Appl Physiol (1985). 2004 Aug;97(2):655-60. doi: 10.1152/japplphysiol.00260.2004. Epub 2004 Apr 16.</citation>
    <PMID>15090482</PMID>
  </reference>
  <reference>
    <citation>Sardinha LB, Lohman TG, Teixeira PJ, Guedes DP, Going SB. Comparison of air displacement plethysmography with dual-energy X-ray absorptiometry and 3 field methods for estimating body composition in middle-aged men. Am J Clin Nutr. 1998 Oct;68(4):786-93. doi: 10.1093/ajcn/68.4.786.</citation>
    <PMID>9771855</PMID>
  </reference>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 16, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 26, 2018</study_first_posted>
  <last_update_submitted>November 21, 2018</last_update_submitted>
  <last_update_submitted_qc>November 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Estadual de Londrina</investigator_affiliation>
    <investigator_full_name>Hellen Clair Garcêz Nabuco</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>sarcopenia</keyword>
  <keyword>obesity</keyword>
  <keyword>protein intake</keyword>
  <keyword>IL-6</keyword>
  <keyword>lean tissue</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Body Weight</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03752359
org study id: UEL1700756-1/2018
nct id: NCT03752359
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main purpose of the present study was to investigate the effects of whey protein
      following resistance training on body composition, muscular strength, functional capacity,
      and plasma-metabolism biomarkers in older women with sarcopenic obesity.
This two-arm randomized, double-blind, placebo-controlled design was carried out over a
      period of 16 weeks. At the beginning and end of the experiment, two weeks were allocated for
      evaluations consisting of anthropometric (weeks 2 and 16), body composition (weeks 2 and 16),
      one repetition maximum tests (weeks 1 and 15), functional capacity tests (weeks 1 and 15),
      blood samples (weeks 2 and 16) and dietary intake measurements (weeks 1 and 15). The
      anthropometric, body composition, blood samples and dietary intake measurements were carried
      out in a temperature-controlled room (22-24 °C), and the RT sessions were conducted at the
      university training facility.

      Recruitment was carried out through newspapers, radio advertising, and home delivery of
      leaflets in the central area and residential neighborhoods. All participants completed health
      history and physical activity questionnaires and were included in the study if they met the
      following inclusion criteria: 60 years old or more, physically independent, free from cardiac
      or orthopedic dysfunction that would prevent them from performing the prescribed exercise or
      exercise testing associated with the study, not receiving hormonal replacement therapy, and
      completed a previous 8-week RT program. In this study, only women with SO were included. SO
      was defined as a body fat mass ≥ 35%(29) combined with appendicular lean soft tissue (ALST)
      less than <15.02 kg(30), assessed by dual x-ray energy absorptiometry (DXA). Participants
      underwent a diagnostic graded exercise stress test with a 12-lead electrocardiogram reviewed
      by a cardiologist and were released with no restrictions for participation in this
      investigation.

      A blinded researcher was responsible for generating random numbers for participant
      allocation. Both groups were submitted to the same RT program and all participants completed
      the experiment. Written informed consent was obtained from all participants after a detailed
      description of investigation procedures was provided. This investigation was conducted
      according to the Declaration of Helsinki and was approved by the local University Ethics
      Committee The Shapiro Wilk test was used to test data distribution. Data are presented as
      means, standard deviation, and z-score. The student's independent t-test and chi-square test
      were used to compare groups regarding the general characteristics and clinical/medical
      history (categorical variables). Two-way analysis of variance (ANOVA) for repeated measures
      was used to assess between group comparisons. The effect size (ES) was calculated to verify
      the magnitude of the differences by Cohen's d, where an ES of 0.20-0.49 was considered as
      small, 0.50-0.79 as moderate, and ≥ 0.80 as large(41). The Z-score of the percentage changes
      (from pre- to post-training) of the raw data for each parameter was calculated, as well as a
      total Z-score, derived from all the components. To verify the differences between groups in
      total Z-scores, an independent T test was also applied. For all statistical analyses,
      significance was accepted at P < 0.05. The data were analyzed using SPSS software version
      20.0 (SPSS, Inc., Chicago, IL, USA).
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Change in body composition
time frame: baseline and after 12 weeks
description: Whole-body dual-energy X-ray absorptiometry (DXA) (Lunar Prodigy) was used to assess lean mass and fat mass and its segments. The total skeletal muscle mass (SMM) was estimated by the predictive equation proposed by Kim et al. (Kim et al., 2004). The results are presented in kg.
measure: Change in Muscular strength
time frame: baseline and after 12 weeks
description: Maximal dynamic strength was evaluated using the 1RM test assessed on chest press, knee extension, and preacher curl exercises performed in this exact order. Testing for each exercise was preceded by a warm-up set (6-10 repetitions), with approximately 50% of the estimated load used in the first attempt of the 1RM. This warm-up was also used to familiarize the subjects with the testing equipment and lifting technique. The testing procedure was initiated 2 minutes after the warm-up. The subjects were instructed to try to accomplish two repetitions with the imposed load in three attempts in both exercises. The rest period was 3 to 5 min between each attempt, and 5 min between exercises. The 1RM was recorded as the last resistance lifted in which the subject was able to complete only one single maximal execution
measure: Change in inflammatory markers
time frame: baseline and after 12 weeks
description: Tumor Necrosis Factor -α (TNF-α) and Interleukin-6 (IL-6) were determined by enzyme-linked immunosorbent assay (ELISA), according to the specifications of the manufacturer and performed in a microplate reader Perkin Elmer, model EnSpire (USA). All samples were determined in duplicate to guarantee the precision of the results. The results are presented in picograms per milliliter (pg/ml).
measure: Change in C-reactive protein (CRP)
time frame: baseline and after 12 weeks
description: Measurements of serum levels of high-sensitivity CRP were carried out using a biochemical auto-analyzer system (Dimension Max - Siemens Dade Behring) according to established methods in the literature consistent with the manufacturer's recommendations. The results are presented in milligrams per decilitre (mg/dL).
measure: Change in oxidative stress
time frame: baseline and after 12 weeks
description: For measurements, advanced oxidation protein products (AOPP) were determined in the plasma using a semiautomatic method. AOPP concentrations were expressed as micromoles per liter (μmol/L). Total plasma antioxidant capacity (TRAP) was determined by the chemiluminescence method for the induction time of 2.2 azo-bis (2-amidinopropane) and calibrated with Trolox analogue of vitamin E. TRAP values were expressed in μmol of Trolox.
measure: Change in Total cholesterol
time frame: baseline and after 12 weeks
description: Measurements of serum levels of total cholesterol were determined using a biochemical auto-analyzer system (Dimension Max - Siemens Dade Behring) according to established methods in the literature consistent with the manufacturer's recommendations.
measure: Change in high-density lipoprotein (HDL-C)
time frame: baseline and after 12 weeks
description: Measurements of serum levels of high-density lipoprotein were determined using a biochemical auto-analyzer system (Dimension Max - Siemens Dade Behring) according to established methods in the literature consistent with the manufacturer's recommendations.
measure: Change in triglycerides
time frame: baseline and after 12 weeks
description: Measurements of serum levels of triglycerides were determined using a biochemical auto-analyzer system (Dimension Max - Siemens Dade Behring) according to established methods in the literature consistent with the manufacturer's recommendations.
measure: Change in low-density lipoprotein
time frame: baseline and after 12 weeks
description: For the determination of LDL-c was used the Friedewald equation: LDL-c=TC - (HDL-c + TG / 5).
measure: Change in glucose
time frame: baseline and after 12 weeks
description: Measurements of serum levels of glucose (GLU) were determined using a biochemical auto-analyzer system (Dimension Max - Siemens Dade Behring).
measure: Change in insulin
time frame: baseline and after 12 weeks
description: Insulin was determined by the chemiluminescence method (LIASON equipment)
measure: Change in HOMA-IR
time frame: baseline and after 12 weeks
description: The Homeostasis Assessment Model (HOMA-IR) was calculated by the formula: Insulin fasting (μUI / mL) x Glucose fasting (mmol / L) / 22.5.
measure: Change in blood pressure
time frame: baseline and after 12 weeks
description: Resting BP assessment was performed using automatic, oscillometric equipment (Omron - 7113). Participants attended the laboratory on three different days and, during each visit, remained seated at rest for 10 min with the cuff of the equipment in place on the right arm. Subsequently, several BP measurements were performed at one-minute intervals in order to obtain three consecutive measurements where the difference in systolic BP (SBP) and diastolic BP (DBP) readings differed by no more than 4 mmHg. The average of the three measurements for each day was averaged across the three visits.
measure: Change in body mass
time frame: baseline and after 12 weeks
description: Body mass was measured to the nearest 0.1 kg using a calibrated electronic scale, with subjects wearing light workout clothing and no shoes.
measure: Change in height
time frame: baseline and after 12 weeks
description: Height was measured using a stadiometer to the nearest 0.1 cm while subjects were standing without shoes.
measure: Change in body mass index
time frame: baseline and after 12 weeks
description: Body mass index was calculated as the body mass in kilograms divided by the square of the height in meters.
measure: Change in waist circumference
time frame: baseline and after 12 weeks
description: We also collected data on waist circumference (WC), using a flexible and inelastic tape measure. WC was obtained at the midpoint between the last rib and the iliac crest at the time of expiration. Two measurements were used to measure each circumference. In situations in which the difference between the measurements was greater than 0.5 cm a third measurement was performed, with the value of the median being adopted as reference. All measurements were performed by the same evaluator.
measure: Change in hip circumference
time frame: baseline and after 12 weeks
description: We also collected data on hip circumference, using a flexible and inelastic tape measure. HC was measured in the region of greater perimeter between the waist and the thigh. Two measurements were used to measure each circumference. In situations in which the difference between the measurements was greater than 0.5 cm a third measurement was performed, with the value of the median being adopted as reference. All measurements were performed by the same evaluator.
measure: Dietary intake
time frame: baseline and after 12 weeks
description: Food consumption were assessed by the 24-hour dietary recall method applied on two non-consecutive days of the week, with the aid of a photographic record taken during an interview. The homemade measurements of the nutritional values of food and supplementation were converted into grams and milliliters by the online software Virtual Nutri Plus for diet analysis. Some foods were not found in the program database and therefore items were added from food tables.
arm group label: whey protein group
arm group type: Experimental
description: Participants received a dose of 35 grams of whey protein after resistance training (RT). Participants were personally supervised by physical education professionals with substantial RT experience. The sessions were performed 3 times per week on Mondays, Wednesdays, and Fridays, with 3 sets of 08-12 repetition maximums. The RT program was a whole-body program with eight exercises, including: chest press, seated row, triceps push-down, preacher curl, horizontal leg press, knee extension, leg curl and seated calf raise. Participants were afforded a 1 to 2 min rest interval between sets and 2 to 3 min between each exercise. The training load was consistent with the prescribed number of repetitions for the three sets of each exercise.
arm group label: placebo group
arm group type: Placebo Comparator
description: Participants received a dose of 35 grams of maltodextrin after resistance training (RT). Participants were personally supervised by physical education professionals with substantial RT experience. The sessions were performed 3 times per week on Mondays, Wednesdays, and Fridays, with 3 sets of 08-12 repetition maximums. The RT program was a whole-body program with eight exercises, including: chest press, seated row, triceps push-down, preacher curl, horizontal leg press, knee extension, leg curl and seated calf raise. Participants were afforded a 1 to 2 min rest interval between sets and 2 to 3 min between each exercise. The training load was consistent with the prescribed number of repetitions for the three sets of each exercise.
intervention type: Dietary Supplement
intervention name: whey protein
description: This two-arm randomized, double-blind, placebo-controlled design was carried out over a period of 16 weeks. At the beginning and end of the experiment, two weeks were allocated for evaluations consisting of anthropometric (weeks 2 and 16), body composition (weeks 2 and 16), one repetition maximum tests (weeks 1 and 15), functional capacity tests (weeks 1 and 15), blood samples (weeks 2 and 16) and dietary intake measurements (weeks 1 and 15). The anthropometric, body composition, blood samples and dietary intake measurements were carried out in a temperature-controlled room (22-24 °C), and the RT sessions were conducted at the university training facility.
arm group label: whey protein group
intervention type: Dietary Supplement
intervention name: placebo
description: This two-arm randomized, double-blind, placebo-controlled design was carried out over a period of 16 weeks. At the beginning and end of the experiment, two weeks were allocated for evaluations consisting of anthropometric (weeks 2 and 16), body composition (weeks 2 and 16), one repetition maximum tests (weeks 1 and 15), functional capacity tests (weeks 1 and 15), blood samples (weeks 2 and 16) and dietary intake measurements (weeks 1 and 15). The anthropometric, body composition, blood samples and dietary intake measurements were carried out in a temperature-controlled room (22-24 °C), and the RT sessions were conducted at the university training facility.
arm group label: placebo group
criteria: 
gender: Female
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Edilson Cyrino, PhD.
role: Study Director
affiliation: Universidade Estadual de Londrina
facility: 
country: Brazil
citation: American College of Sports Medicine. American College of Sports Medicine position stand. Progression models in resistance training for healthy adults. Med Sci Sports Exerc. 2009 Mar;41(3):687-708. doi: 10.1249/MSS.0b013e3181915670.
PMID: 19204579
citation: Kim J, Heshka S, Gallagher D, Kotler DP, Mayer L, Albu J, Shen W, Freda PU, Heymsfield SB. Intermuscular adipose tissue-free skeletal muscle mass: estimation by dual-energy X-ray absorptiometry in adults. J Appl Physiol (1985). 2004 Aug;97(2):655-60. doi: 10.1152/japplphysiol.00260.2004. Epub 2004 Apr 16.
PMID: 15090482
citation: Sardinha LB, Lohman TG, Teixeira PJ, Guedes DP, Going SB. Comparison of air displacement plethysmography with dual-energy X-ray absorptiometry and 3 field methods for estimating body composition in middle-aged men. Am J Clin Nutr. 1998 Oct;68(4):786-93. doi: 10.1093/ajcn/68.4.786.
PMID: 9771855
responsible party type: Principal Investigator
investigator affiliation: Universidade Estadual de Londrina
investigator full name: Hellen Clair Garcêz Nabuco
investigator title: Principal Investigator
mesh term: Obesity
mesh term: Body Weight