<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/NCT03792646</url>
  </required_header>
  <id_info>
    <org_study_id>Diabéticos</org_study_id>
    <nct_id>NCT03792646</nct_id>
  </id_info>
  <brief_title>Protein Supplementation: Body Composition, Muscle Strength and Postural Balance</brief_title>
  <official_title>Effect of Protein Supplementation on Body Composition, Muscle Strength and Postural Balance in Elderly Type II Diabetes Subjects Undergoing Resistance Training</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo General Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Nutritional interventions witch stimulate the rate of muscle protein synthesis are relevant&#xD;
      for the development of therapeutic strategies aimed at attenuating the loss of mass and&#xD;
      muscle strength related to aging (sarcopenia). To aim of the study is to investigate the&#xD;
      effect of protein supplementation on body composition, muscle activity, muscle strength and&#xD;
      plasma concentration of inflammatory biomarkers of elderly with type II diabetic, submitted&#xD;
      to 12 weeks of resistance training. This is an interventional, controlled, randomized,&#xD;
      double-blind study. The population of the present study will be composed of 40 men with type&#xD;
      2 diabetes aged between 70 and 74 years, whose body mass index (BMI) should be between 22 and&#xD;
      32 kg / m2. It will be composed of patients from the Diabetes Outpatient Clinic of the&#xD;
      Endocrinology Department at the Medical School of the University of São Paulo. Elderly&#xD;
      subjects will be randomized into two groups (n = 20) who will undergo resistance training for&#xD;
      12 weeks, twice a week, and receive protein or placebo supplementation. Exercises will be&#xD;
      performed for the large muscle groups: pectoral press, paddling, leg-press, extensor chair,&#xD;
      gastrocnemius plantar flexions and abdominal crunches. Protein supplementation will be&#xD;
      performed immediately after strength training by ingestion of 20 g of whey protein diluted in&#xD;
      water. Also, immediately after training the placebo group will receive 20 g of maltodextrin&#xD;
      diluted in water. All participants will be instructed to ingest 1.0 to 1.2 g of protein / kg&#xD;
      of body weight per day. 24-hour food recall and food frequency questionnaires will be&#xD;
      performed throughout the study. The following evaluations (before and after 12 weeks&#xD;
      training) will be applied: Anthropometric: body mass, height, BMI and hip waist ratio.&#xD;
      Functional evaluation through isokinetic dynamometry of knee extensors and flexors and a&#xD;
      maximal repetition (1RM). Evaluation of body composition through Bioimpedance balance.&#xD;
      Evaluation of food intake will be obtained by means of a 24-hour recall and food frequency&#xD;
      questionnaire. All the evaluations will performed after 6 months. The training sessions will&#xD;
      have a frequency of twice a week for 12 weeks. Eight exercises will be performed for the main&#xD;
      muscle groups. In each exercise, 3 sets will be performed between 8 and 12 repetitions. The&#xD;
      intensity should be between 7 - 8 and will be monitored according to Subjective Effort&#xD;
      Perception using a scale of 0 to 10.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Eligibility Criteria:&#xD;
&#xD;
      Diabetes mellitus type 2 with stable dose of medication (oral antidiabetic or insulin or&#xD;
      combination of both) for three months or more.&#xD;
&#xD;
      Glycated hemoglobin between 6 and 8.5% Renal function assessed by MDRD above 60 ml / h AST&#xD;
      and ALT up to 2.5 times the upper limit of the No involvement of the musculoskeletal system&#xD;
      with pain and any type of incapacitating disease or previous surgeries.&#xD;
&#xD;
      No chronic non-communicable disease not treated properly and decompensated Renal function&#xD;
      assessed by MDRD equal to or above 60 ml / h&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 1, 2018</start_date>
  <completion_date type="Anticipated">March 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2020</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>Parallel Assignment</intervention_model>
    <intervention_model_description>Randomized prospective clinical trial, double-blind, placebo-controlled intervention</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Muscular strength (hand grip) change from baseline</measure>
    <time_frame>This measure will be perform before and after the intervention (12 weeks muscular strenght and postural balance exercise) and after 6 months.</time_frame>
    <description>Evaluation of muscular strength improvement- hand grip strength (HGS). HGS assessment was performed using a Jamar hand dynamometer, measured in kilograms (kg), which is adopted by the American Society of Hand Therapists.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Muscular strength (peak of torque) change from baseline</measure>
    <time_frame>This measure will be perform before and after the intervention (12 weeks muscular strenght and postural balance exercise) and after 6 months.</time_frame>
    <description>Isokinetic dynamometry will be use to determine knee extension and flexion strength using the Biodex Multi-Joint System 3 (Biodex MedicalTM, Shirley, NY, USA). The isokinetic variables used was maximum peak torque corrected for body weight (%).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Muscular strength (total work) change from baseline</measure>
    <time_frame>This measure will be perform before and after the intervention (12 weeks muscular strenght and postural balance exercise) and after 6 months.</time_frame>
    <description>Isokinetic dynamometry will be use to determine knee extension and flexion strength using the Biodex Multi-Joint System 3 (Biodex MedicalTM, Shirley, NY, USA). The isokinetic variables used was total work (J).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postural Balance (weight transfer) change from baseline</measure>
    <time_frame>This measure will be perform before and after the intervention (12 weeks muscular strenght and postural balance exercise) and after 6 months.</time_frame>
    <description>The postural balance assessment (posturography) was performed on the NeuroCom Balance Master® force platform system (NeuroCom International, Inc., Clackamas, Oregon, USA). The parameter measured was the mean weight transfer. The weight transfer was the time in seconds required to voluntarily shift the COG forwards, beginning in the seated position and ending with full weight-bearing on the feet.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postural Balance (sway velocity) change from baseline</measure>
    <time_frame>This measure will be perform before and after the intervention (12 weeks muscular strenght and postural balance exercise) and after 6 months.</time_frame>
    <description>The postural balance assessment (posturography) was performed on the NeuroCom Balance Master® force platform system (NeuroCom International, Inc., Clackamas, Oregon, USA). The parameter measured was the center of gravity (COG) sway velocity while rising. The COG sway velocity documented the degree of control over the COG above the support base during the rising phase and for 5 seconds thereafter. Sway was expressed in degrees per second.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Inflammatory biomarkers - plasma concentration change from baseline (Interleukin 6)</measure>
    <time_frame>This measure will be perform before and after the intervention (12 weeks muscular strenght and postural balance exercise).</time_frame>
    <description>Peripheral blood samples (20 mL) will be collected in tubes containing EDTA anticoagulant at the initial times and 12 weeks of treatment. The total EDTA blood will be centrifuged to obtain the plasma, which will be used to evaluate the concentration of Interleukin 6 (IL-6). IL-6 is an interleukin that acts as a proinflammatory cytokine and an anti-inflammatory miocin. The IL-6 will be measure in microliter (μl)/pictogram (pg). From the whole blood with EDTA will be performed the complete blood count.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Portable Bioelectrical Impedance change from baseline</measure>
    <time_frame>This measure will be perform before and after the intervention (12 weeks muscular strenght and postural balance exercise) and after 6 months.</time_frame>
    <description>Measure body composition, such as % body fat and fat-free mass (FFM). The total body mass and body composition will be measured using a multipolar bio-impedance scale of the brand INBODY® model 230.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammatory biomarkers - plasma concentration change from baseline (Tumor necrosis factor-alpha)</measure>
    <time_frame>This measure will be perform before and after the intervention (12 weeks muscular strenght and postural balance exercise).</time_frame>
    <description>Peripheral blood samples (20 mL) will be collected in tubes containing EDTA anticoagulant at the initial times and 12 weeks of treatment. The total EDTA blood will be centrifuged to obtain the plasma, which will be used to evaluate the concentration of tumor necrosis factor (TNF) -alpha. The TNF-alfa is a cell signaling protein (cytokine) involved in systemic inflammation and is one of the cytokines that make up the acute phase reaction. The TNF-alfa wiil be measure in microliter (μl)/pictogram (pg). From the whole blood with EDTA will be performed the complete blood count.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <condition>Protein Supplementation</condition>
  <condition>Body Composition</condition>
  <condition>Inflammation Biomarkers</condition>
  <condition>Resistance Training</condition>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The experimental group will inject 20 grams of whey protein diluted in water after the exercise training.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The placebo group will inject 20 grams of maltodextrin diluted in water after the exercise training.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Whey protein</intervention_name>
    <description>Exercise training + 20g whey protein</description>
    <arm_group_label>Experimental</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise training</intervention_name>
    <description>Strength exercise</description>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diabetes mellitus type 2 with stable dose of medication (oral antidiabetic or insulin&#xD;
             or combination of both) for three months or more.&#xD;
&#xD;
          -  Glycated hemoglobin between 6 and 8.5%&#xD;
&#xD;
          -  Renal function assessed by MDRD above 60 ml / h&#xD;
&#xD;
          -  AST and ALT up to 2.5 times the upper limit of the&#xD;
&#xD;
          -  No involvement of the musculoskeletal system with pain and any type of incapacitating&#xD;
             disease or previous surgeries.&#xD;
&#xD;
          -  No chronic non-communicable disease not treated properly and decompensated&#xD;
&#xD;
          -  Renal function assessed by MDRD equal to or above 60 ml / h&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Impossibility to conduct evaluation and training efficiently&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Julia C Greve, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of São Paulo</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Julia Greve, Professor</last_name>
    <phone>2661-6908</phone>
    <email>jgreve@usp.br</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Guilherme Brech</last_name>
    <phone>11998117869</phone>
    <email>guibrech@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Julia Maria DÀndrea Greve</name>
      <address>
        <city>São Paulo</city>
        <zip>04503-010</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Guilherme C Brech, PhD</last_name>
      <phone>2661-6908</phone>
      <email>guibrech@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Guilherme C Brech, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>November 12, 2018</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <last_update_submitted>January 2, 2019</last_update_submitted>
  <last_update_submitted_qc>January 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Supplementary Feeding</keyword>
  <keyword>Protein</keyword>
  <keyword>Muscle strenght</keyword>
  <keyword>Exercise</keyword>
  <keyword>Aged</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03792646
org study id: Diabéticos
nct id: NCT03792646
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Nutritional interventions witch stimulate the rate of muscle protein synthesis are relevant
      for the development of therapeutic strategies aimed at attenuating the loss of mass and
      muscle strength related to aging (sarcopenia). To aim of the study is to investigate the
      effect of protein supplementation on body composition, muscle activity, muscle strength and
      plasma concentration of inflammatory biomarkers of elderly with type II diabetic, submitted
      to 12 weeks of resistance training. This is an interventional, controlled, randomized,
      double-blind study. The population of the present study will be composed of 40 men with type
      2 diabetes aged between 70 and 74 years, whose body mass index (BMI) should be between 22 and
      32 kg / m2. It will be composed of patients from the Diabetes Outpatient Clinic of the
      Endocrinology Department at the Medical School of the University of São Paulo. Elderly
      subjects will be randomized into two groups (n = 20) who will undergo resistance training for
      12 weeks, twice a week, and receive protein or placebo supplementation. Exercises will be
      performed for the large muscle groups: pectoral press, paddling, leg-press, extensor chair,
      gastrocnemius plantar flexions and abdominal crunches. Protein supplementation will be
      performed immediately after strength training by ingestion of 20 g of whey protein diluted in
      water. Also, immediately after training the placebo group will receive 20 g of maltodextrin
      diluted in water. All participants will be instructed to ingest 1.0 to 1.2 g of protein / kg
      of body weight per day. 24-hour food recall and food frequency questionnaires will be
      performed throughout the study. The following evaluations (before and after 12 weeks
      training) will be applied: Anthropometric: body mass, height, BMI and hip waist ratio.
      Functional evaluation through isokinetic dynamometry of knee extensors and flexors and a
      maximal repetition (1RM). Evaluation of body composition through Bioimpedance balance.
      Evaluation of food intake will be obtained by means of a 24-hour recall and food frequency
      questionnaire. All the evaluations will performed after 6 months. The training sessions will
      have a frequency of twice a week for 12 weeks. Eight exercises will be performed for the main
      muscle groups. In each exercise, 3 sets will be performed between 8 and 12 repetitions. The
      intensity should be between 7 - 8 and will be monitored according to Subjective Effort
      Perception using a scale of 0 to 10.
Eligibility Criteria:

      Diabetes mellitus type 2 with stable dose of medication (oral antidiabetic or insulin or
      combination of both) for three months or more.

      Glycated hemoglobin between 6 and 8.5% Renal function assessed by MDRD above 60 ml / h AST
      and ALT up to 2.5 times the upper limit of the No involvement of the musculoskeletal system
      with pain and any type of incapacitating disease or previous surgeries.

      No chronic non-communicable disease not treated properly and decompensated Renal function
      assessed by MDRD equal to or above 60 ml / h
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized prospective clinical trial, double-blind, placebo-controlled intervention
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Muscular strength (hand grip) change from baseline
time frame: This measure will be perform before and after the intervention (12 weeks muscular strenght and postural balance exercise) and after 6 months.
description: Evaluation of muscular strength improvement- hand grip strength (HGS). HGS assessment was performed using a Jamar hand dynamometer, measured in kilograms (kg), which is adopted by the American Society of Hand Therapists.
measure: Muscular strength (peak of torque) change from baseline
time frame: This measure will be perform before and after the intervention (12 weeks muscular strenght and postural balance exercise) and after 6 months.
description: Isokinetic dynamometry will be use to determine knee extension and flexion strength using the Biodex Multi-Joint System 3 (Biodex MedicalTM, Shirley, NY, USA). The isokinetic variables used was maximum peak torque corrected for body weight (%).
measure: Muscular strength (total work) change from baseline
time frame: This measure will be perform before and after the intervention (12 weeks muscular strenght and postural balance exercise) and after 6 months.
description: Isokinetic dynamometry will be use to determine knee extension and flexion strength using the Biodex Multi-Joint System 3 (Biodex MedicalTM, Shirley, NY, USA). The isokinetic variables used was total work (J).
measure: Postural Balance (weight transfer) change from baseline
time frame: This measure will be perform before and after the intervention (12 weeks muscular strenght and postural balance exercise) and after 6 months.
description: The postural balance assessment (posturography) was performed on the NeuroCom Balance Master® force platform system (NeuroCom International, Inc., Clackamas, Oregon, USA). The parameter measured was the mean weight transfer. The weight transfer was the time in seconds required to voluntarily shift the COG forwards, beginning in the seated position and ending with full weight-bearing on the feet.
measure: Postural Balance (sway velocity) change from baseline
time frame: This measure will be perform before and after the intervention (12 weeks muscular strenght and postural balance exercise) and after 6 months.
description: The postural balance assessment (posturography) was performed on the NeuroCom Balance Master® force platform system (NeuroCom International, Inc., Clackamas, Oregon, USA). The parameter measured was the center of gravity (COG) sway velocity while rising. The COG sway velocity documented the degree of control over the COG above the support base during the rising phase and for 5 seconds thereafter. Sway was expressed in degrees per second.
measure: Inflammatory biomarkers - plasma concentration change from baseline (Interleukin 6)
time frame: This measure will be perform before and after the intervention (12 weeks muscular strenght and postural balance exercise).
description: Peripheral blood samples (20 mL) will be collected in tubes containing EDTA anticoagulant at the initial times and 12 weeks of treatment. The total EDTA blood will be centrifuged to obtain the plasma, which will be used to evaluate the concentration of Interleukin 6 (IL-6). IL-6 is an interleukin that acts as a proinflammatory cytokine and an anti-inflammatory miocin. The IL-6 will be measure in microliter (μl)/pictogram (pg). From the whole blood with EDTA will be performed the complete blood count.
measure: Portable Bioelectrical Impedance change from baseline
time frame: This measure will be perform before and after the intervention (12 weeks muscular strenght and postural balance exercise) and after 6 months.
description: Measure body composition, such as % body fat and fat-free mass (FFM). The total body mass and body composition will be measured using a multipolar bio-impedance scale of the brand INBODY® model 230.
measure: Inflammatory biomarkers - plasma concentration change from baseline (Tumor necrosis factor-alpha)
time frame: This measure will be perform before and after the intervention (12 weeks muscular strenght and postural balance exercise).
description: Peripheral blood samples (20 mL) will be collected in tubes containing EDTA anticoagulant at the initial times and 12 weeks of treatment. The total EDTA blood will be centrifuged to obtain the plasma, which will be used to evaluate the concentration of tumor necrosis factor (TNF) -alpha. The TNF-alfa is a cell signaling protein (cytokine) involved in systemic inflammation and is one of the cytokines that make up the acute phase reaction. The TNF-alfa wiil be measure in microliter (μl)/pictogram (pg). From the whole blood with EDTA will be performed the complete blood count.
arm group label: Experimental
arm group type: Experimental
description: The experimental group will inject 20 grams of whey protein diluted in water after the exercise training.
arm group label: Placebo
arm group type: Placebo Comparator
description: The placebo group will inject 20 grams of maltodextrin diluted in water after the exercise training.
intervention type: Dietary Supplement
intervention name: Whey protein
description: Exercise training + 20g whey protein
arm group label: Experimental
intervention type: Other
intervention name: Exercise training
description: Strength exercise
arm group label: Experimental
arm group label: Placebo
criteria: 
gender: Male
minimum age: 65 Years
maximum age: 79 Years
healthy volunteers: No
last name: Julia C Greve, Professor
role: Principal Investigator
affiliation: University of São Paulo
last name: Julia Greve, Professor
phone: 2661-6908
email: jgreve@usp.br
last name: Guilherme Brech
phone: 11998117869
email: guibrech@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Brazil
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 2
mesh term: Inflammation
sharing ipd: Undecided