<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/NCT03819478</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00038668-A</org_study_id>
    <secondary_id>IRB00038668</secondary_id>
    <secondary_id>K25AG058804</secondary_id>
    <nct_id>NCT03819478</nct_id>
  </id_info>
  <brief_title>Utilizing Protein During Weight Loss to Impact Physical Function and Bone</brief_title>
  <acronym>UPLIFT-Bone</acronym>
  <official_title>Effect of Protein Supplementation During Weight Loss on Older Adult Bone Health</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Wake Forest University Health Sciences</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This study is an ancillary study to the Utilizing Protein During Weight Loss to Impact&#xD;
      Physical Function (UPLIFT) trial (NCT03074643) to evaluate the effects of diet composition&#xD;
      (i.e., amount of protein and carbohydrate) during a 6-month weight loss intervention and&#xD;
      12-months of follow-up on bone phenotypes in obese older adults. Participants will receive&#xD;
      either a protein or carbohydrate supplement along with a behavioral weight loss intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The ancillary study to the UPLIFT trial (NCT03074643) will use a 3-group design in 225 obese&#xD;
      (body mass index [BMI] 30-45 kg/m2 or 27-&lt;30 kg/m2 with an obesity-related risk factor),&#xD;
      older (65-85 years) men and women at risk for disability (Short Physical Performance Battery,&#xD;
      SPPB ≤10) who will undergo a 6-month weight loss intervention followed by a 12-month&#xD;
      follow-up phase to test the overall hypothesis that a higher protein (1.2 g/kg body&#xD;
      weight/day) / lower carbohydrate (CHO) diet during a 6-month weight loss intervention&#xD;
      improves bone phenotypes compared with an isocaloric lower protein (the current Recommended&#xD;
      Dietary Allowance (RDA), 0.8 g/kg body wt/d) / higher CHO diet, and whether continuing a&#xD;
      higher protein / lower CHO diet for 12-months following weight loss will result in better&#xD;
      maintenance of bone. All participants will undergo a 6-month weight loss intervention&#xD;
      involving caloric restriction and supervised exercise followed by 12 months of follow-up with&#xD;
      randomization to one of three groups (n=75/group): 1) Lower protein / higher CHO diet for the&#xD;
      6-month weight loss phase only (RecProt); 2) Higher protein / lower CHO diet for the 6-month&#xD;
      weight loss phase only (6-mo HiProt); or 3) Higher protein / lower CHO diet for the 6-month&#xD;
      weight loss and 12-month follow-up phases (18-mo HiProt). Vertebral and femoral volumetric&#xD;
      bone mineral density and cortical thickness (Primary Aim) and bone marrow adipose tissue&#xD;
      (Secondary Aim 1) will be assessed with computed tomography at baseline, 6-, and 18-months.&#xD;
      Bone strength and fracture risk (Secondary Aim 2) will be assessed by finite element modeling&#xD;
      at baseline, 6-, and 18-months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 3, 2017</start_date>
  <completion_date type="Actual">April 28, 2022</completion_date>
  <primary_completion_date type="Actual">April 28, 2022</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>All participants will undergo a 6-month weight loss intervention of caloric restriction and supervised exercise followed by 12 months of follow-up with randomization to one of three groups (n=75/group): 1) Lower protein / higher CHO diet for the 6-month weight loss phase only (RecProt); 2) Higher protein / lower CHO diet for the 6-month weight loss phase only (6-mo HiProt); or 3) Higher protein / lower CHO diet for the 6-month weight loss and 12-month follow-up phases (18-mo HiProt).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Femoral volumetric bone mineral density assessed by computed tomography (CT)</measure>
    <time_frame>18 months</time_frame>
    <description>To determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet during a 6-month weight loss intervention and 12 months of follow-up on 18-month femoral volumetric bone mineral density</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fraction of adipose tissue within the bone marrow as assessed by a dual-energy computed tomography algorithm</measure>
    <time_frame>6 months</time_frame>
    <description>To determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet during a 6-month weight loss intervention on the 6-month fraction of adipose tissue within the bone marrow as assessed by a dual-energy computed tomography algorithm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fraction of adipose tissue within the bone marrow as assessed by a dual-energy computed tomography algorithm</measure>
    <time_frame>18 months</time_frame>
    <description>To determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet during a 6-month weight loss intervention and 12 months of follow-up on the 18-month fraction of adipose tissue within the bone marrow as assessed by a dual-energy computed tomography algorithm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Femoral bone strength as assessed by subject-specific finite element modeling</measure>
    <time_frame>6 months</time_frame>
    <description>To determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet during a 6-month weight loss intervention on 6-month femoral bone strength as assessed by subject-specific finite element modeling</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Femoral bone strength as assessed by subject-specific finite element modeling</measure>
    <time_frame>18 months</time_frame>
    <description>To determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet during a 6-month weight loss intervention and 12 months of follow-up on 18-month femoral bone strength as assessed by subject-specific finite element modeling</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Femoral cortical thickness as assessed by a computed tomography based algorithm</measure>
    <time_frame>18 months</time_frame>
    <description>To determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet during a 6-month weight loss intervention and 12 months of follow-up on 18-month femoral cortical thickness as assessed by a computed tomography based algorithm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Femoral cortical thickness as assessed by a computed tomography based algorithm</measure>
    <time_frame>6 months</time_frame>
    <description>To determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet during a 6-month weight loss intervention on 6-month femoral cortical thickness as assessed by a computed tomography based algorithm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vertebral volumetric bone mineral density</measure>
    <time_frame>18 months</time_frame>
    <description>To determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet during a 6-month weight loss intervention and 12 months of follow-up on 18-month vertebral volumetric bone mineral density</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vertebral volumetric bone mineral density</measure>
    <time_frame>6 months</time_frame>
    <description>To determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet during a 6-month weight loss intervention on 6-month vertebral volumetric bone mineral density.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Femoral volumetric bone mineral density</measure>
    <time_frame>6 months</time_frame>
    <description>To determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet during a 6-month weight loss intervention on 6-month femoral volumetric bone mineral density</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">187</enrollment>
  <condition>Obesity</condition>
  <condition>Weight Loss</condition>
  <condition>Diet Modification</condition>
  <condition>Aging</condition>
  <condition>Weight Change, Body</condition>
  <condition>Dietary Habits</condition>
  <condition>Osteopenia, Osteoporosis</condition>
  <condition>Bone Loss</condition>
  <condition>Fractures, Bone</condition>
  <arm_group>
    <arm_group_label>RecProt</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects receiving the following interventions in the parent trial (UPLIFT; NCT03074643): Lower protein / higher CHO diet for the 6-month weight loss phase. Exercise intervention months 0-6. Weight loss intervention months 0-6. Carbohydrate supplement for months 0-6 (blinded). Follow-up months 7-18.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>6-mo HiProt</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects receiving the following interventions in the parent trial (UPLIFT; NCT03074643): Higher protein / lower CHO diet for the 6-month weight loss phase. Exercise intervention months 0-6. Weight loss intervention months 0-6. Protein supplement for months 0-6 (blinded). Follow-up months 7-18.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>18-mo HiProt</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects receiving the following interventions in the parent trial (UPLIFT; NCT03074643):&#xD;
Higher protein / lower CHO diet for the 6-month weight loss and 12-month follow-up phases. Exercise intervention months 0-6. Weight loss intervention months 0-6. Protein supplement for months 0-6 (blinded). Protein supplement for follow-up months 7-18.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Weight loss intervention months 0-6</intervention_name>
    <description>All participants will undergo a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The weight loss intervention will incorporate nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions will be held weekly in a 3:1 ratio (3 group and 1 individual session per month).</description>
    <arm_group_label>18-mo HiProt</arm_group_label>
    <arm_group_label>6-mo HiProt</arm_group_label>
    <arm_group_label>RecProt</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise intervention months 0-6</intervention_name>
    <description>All participants will be expected to participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (e.g., treadmill walking) 3 days/wk during the 6-month weight loss intervention in accordance with the American Heart Association and the American College of Sports Medicine physical activity recommendations for older adults.</description>
    <arm_group_label>18-mo HiProt</arm_group_label>
    <arm_group_label>6-mo HiProt</arm_group_label>
    <arm_group_label>RecProt</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>NutraBio™ CarboMax Supplement</intervention_name>
    <description>Participants in the lower protein / higher CHO diet group (RecProt) will be provided a carbohydrate supplement (NutraBio™ CarboMax, ~50 g of carbohydrate and 220 calories) to consume daily during the 6 month weight loss intervention.</description>
    <arm_group_label>RecProt</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>6-month NutraBio™ 100% Whey Protein Isolate Supplement</intervention_name>
    <description>Participants in the 6-month higher protein / lower CHO diet group (6-mo HiProt) will be provided a protein supplement (NutraBio™ 100% Whey Protein Isolate, ~50 g of protein and 220 calories) to consume daily during the 6 month weight loss intervention.</description>
    <arm_group_label>6-mo HiProt</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>18-month NutraBio™ 100% Whey Protein Isolate Supplement</intervention_name>
    <description>Participants in the 18-month higher protein / lower CHO diet (18-mo HiProt) will be provided a protein supplement (NutraBio™ 100% Whey Protein Isolate, ~50 g of protein and 220 calories) to consume daily during the 6 month weight loss intervention and the 12-month follow-up.</description>
    <arm_group_label>18-mo HiProt</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Subjects are recruited using inclusion and exclusion criteria of the parent trial (UPLIFT;&#xD;
        NCT03074643).&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  65-85 years&#xD;
&#xD;
          -  BMI: 30-45 kg/m2 or BMI 27.0 - &lt;30.0 AND at least one of the following risk factors:&#xD;
&#xD;
               1. elevated waist circumference (&gt;35 inches in women, &gt;40 inches in men)&#xD;
&#xD;
               2. diabetes,&#xD;
&#xD;
               3. hypertension,&#xD;
&#xD;
               4. dyslipidemia,&#xD;
&#xD;
               5. or other obesity-related comorbidities: clinically manifest coronary artery&#xD;
                  disease [e.g., history of myocardial infarction, angina pectoris, coronary artery&#xD;
                  surgery, coronary artery procedures (e.g., angioplasty) if not within the past&#xD;
                  year], other atherosclerotic disease [e.g., peripheral arterial disease,&#xD;
                  abdominal aortic aneurysm, symptomatic carotid artery disease if not within the&#xD;
                  past year], sleep apnea, or osteoarthritis of the knee or hip.&#xD;
&#xD;
          -  No regular resistance training and/or aerobic exercise (&gt;20 mins/d) for past 6 months&#xD;
&#xD;
          -  SPPB ≥3 to ≤10&#xD;
&#xD;
          -  No contraindications for safe and optimal participation in exercise training&#xD;
&#xD;
          -  Approved for participation by Medical Director (Dr. Lyles)&#xD;
&#xD;
          -  Willing to provide informed consent&#xD;
&#xD;
          -  Agree to all study procedures and assessments&#xD;
&#xD;
          -  Willing to consume protein/CHO supplements for up to 18 months&#xD;
&#xD;
          -  Able to provide own transportation to study visits and intervention sessions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Weight loss (≥5%) in past 6 months&#xD;
&#xD;
          -  Dependent on cane or walker&#xD;
&#xD;
          -  Cognitive impairment (Montreal Cognitive Assessment, MoCA score &lt;22)&#xD;
&#xD;
          -  Severe arthritis, or other musculoskeletal disorder&#xD;
&#xD;
          -  Joint replacement or other orthopedic surgery in past year&#xD;
&#xD;
          -  Uncontrolled resting hypertension (&gt;160/90 mmHg);&#xD;
&#xD;
          -  Uncontrolled diabetes (hemoglobin A1c, HbA1c ≥8.0%)&#xD;
&#xD;
          -  Current or recent past (within 1 year) severe symptomatic heart disease, uncontrolled&#xD;
             angina, stroke, chronic respiratory disease requiring oxygen; uncontrolled&#xD;
             endocrine/metabolic disease; neurological or hematological disease; cancer requiring&#xD;
             treatment in past year, except non-melanoma skin cancers; liver or renal disease; or&#xD;
             clinically evident edema&#xD;
&#xD;
          -  Unstable Severe Depression&#xD;
&#xD;
          -  Serious conduction disorder, uncontrolled arrhythmia, or new Q waves or ST-segment&#xD;
             depressions (&gt;3 mm at rest or ≥2 mm with exercise)&#xD;
&#xD;
          -  Abnormal kidney function (estimated glomerular rate &lt;30 based on serum creatinine,&#xD;
             age, gender, and race)&#xD;
&#xD;
          -  Anemia (Hb&lt;13 g/dL in men; &lt;12 g/dL in women)&#xD;
&#xD;
          -  Drug abuse or excessive alcohol use (&gt;7 drinks/week women; &gt;14 drinks/week men)&#xD;
&#xD;
          -  Use of any tobacco or nicotine products in the past year&#xD;
&#xD;
          -  Osteoporosis (T-score &lt; -2.5 on hip or spine scan)&#xD;
&#xD;
          -  Regular use of growth/steroid hormones, sex steroids or corticosteroids&#xD;
&#xD;
          -  Osteoporosis medication&#xD;
&#xD;
          -  Protein supplements (and unwilling to stop using for duration of study)&#xD;
&#xD;
          -  Weight loss medications or procedures&#xD;
&#xD;
          -  Current participation in another intervention study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ashley Weaver, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wake Forest University Health Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Geriatric Research Center at Wake Forest Baptist Health</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>January 18, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <disposition_first_submitted>April 6, 2023</disposition_first_submitted>
  <disposition_first_submitted_qc>April 20, 2023</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">April 24, 2023</disposition_first_posted>
  <last_update_submitted>April 24, 2023</last_update_submitted>
  <last_update_submitted_qc>April 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoporosis</mesh_term>
    <mesh_term>Bone Diseases, Metabolic</mesh_term>
    <mesh_term>Body Weight</mesh_term>
    <mesh_term>Weight Loss</mesh_term>
    <mesh_term>Body Weight Changes</mesh_term>
    <mesh_term>Fractures, Bone</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 25, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/78/NCT03819478/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT03819478
org study id: IRB00038668-A
secondary id: IRB00038668
secondary id: K25AG058804
nct id: NCT03819478
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study is an ancillary study to the Utilizing Protein During Weight Loss to Impact
      Physical Function (UPLIFT) trial (NCT03074643) to evaluate the effects of diet composition
      (i.e., amount of protein and carbohydrate) during a 6-month weight loss intervention and
      12-months of follow-up on bone phenotypes in obese older adults. Participants will receive
      either a protein or carbohydrate supplement along with a behavioral weight loss intervention.
The ancillary study to the UPLIFT trial (NCT03074643) will use a 3-group design in 225 obese
      (body mass index [BMI] 30-45 kg/m2 or 27-<30 kg/m2 with an obesity-related risk factor),
      older (65-85 years) men and women at risk for disability (Short Physical Performance Battery,
      SPPB ≤10) who will undergo a 6-month weight loss intervention followed by a 12-month
      follow-up phase to test the overall hypothesis that a higher protein (1.2 g/kg body
      weight/day) / lower carbohydrate (CHO) diet during a 6-month weight loss intervention
      improves bone phenotypes compared with an isocaloric lower protein (the current Recommended
      Dietary Allowance (RDA), 0.8 g/kg body wt/d) / higher CHO diet, and whether continuing a
      higher protein / lower CHO diet for 12-months following weight loss will result in better
      maintenance of bone. All participants will undergo a 6-month weight loss intervention
      involving caloric restriction and supervised exercise followed by 12 months of follow-up with
      randomization to one of three groups (n=75/group): 1) Lower protein / higher CHO diet for the
      6-month weight loss phase only (RecProt); 2) Higher protein / lower CHO diet for the 6-month
      weight loss phase only (6-mo HiProt); or 3) Higher protein / lower CHO diet for the 6-month
      weight loss and 12-month follow-up phases (18-mo HiProt). Vertebral and femoral volumetric
      bone mineral density and cortical thickness (Primary Aim) and bone marrow adipose tissue
      (Secondary Aim 1) will be assessed with computed tomography at baseline, 6-, and 18-months.
      Bone strength and fracture risk (Secondary Aim 2) will be assessed by finite element modeling
      at baseline, 6-, and 18-months.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: All participants will undergo a 6-month weight loss intervention of caloric restriction and supervised exercise followed by 12 months of follow-up with randomization to one of three groups (n=75/group): 1) Lower protein / higher CHO diet for the 6-month weight loss phase only (RecProt); 2) Higher protein / lower CHO diet for the 6-month weight loss phase only (6-mo HiProt); or 3) Higher protein / lower CHO diet for the 6-month weight loss and 12-month follow-up phases (18-mo HiProt).
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Femoral volumetric bone mineral density assessed by computed tomography (CT)
time frame: 18 months
description: To determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet during a 6-month weight loss intervention and 12 months of follow-up on 18-month femoral volumetric bone mineral density
measure: Fraction of adipose tissue within the bone marrow as assessed by a dual-energy computed tomography algorithm
time frame: 6 months
description: To determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet during a 6-month weight loss intervention on the 6-month fraction of adipose tissue within the bone marrow as assessed by a dual-energy computed tomography algorithm
measure: Fraction of adipose tissue within the bone marrow as assessed by a dual-energy computed tomography algorithm
time frame: 18 months
description: To determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet during a 6-month weight loss intervention and 12 months of follow-up on the 18-month fraction of adipose tissue within the bone marrow as assessed by a dual-energy computed tomography algorithm
measure: Femoral bone strength as assessed by subject-specific finite element modeling
time frame: 6 months
description: To determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet during a 6-month weight loss intervention on 6-month femoral bone strength as assessed by subject-specific finite element modeling
measure: Femoral bone strength as assessed by subject-specific finite element modeling
time frame: 18 months
description: To determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet during a 6-month weight loss intervention and 12 months of follow-up on 18-month femoral bone strength as assessed by subject-specific finite element modeling
measure: Femoral cortical thickness as assessed by a computed tomography based algorithm
time frame: 18 months
description: To determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet during a 6-month weight loss intervention and 12 months of follow-up on 18-month femoral cortical thickness as assessed by a computed tomography based algorithm
measure: Femoral cortical thickness as assessed by a computed tomography based algorithm
time frame: 6 months
description: To determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet during a 6-month weight loss intervention on 6-month femoral cortical thickness as assessed by a computed tomography based algorithm
measure: Vertebral volumetric bone mineral density
time frame: 18 months
description: To determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet during a 6-month weight loss intervention and 12 months of follow-up on 18-month vertebral volumetric bone mineral density
measure: Vertebral volumetric bone mineral density
time frame: 6 months
description: To determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet during a 6-month weight loss intervention on 6-month vertebral volumetric bone mineral density.
measure: Femoral volumetric bone mineral density
time frame: 6 months
description: To determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet during a 6-month weight loss intervention on 6-month femoral volumetric bone mineral density
arm group label: RecProt
arm group type: Active Comparator
description: Subjects receiving the following interventions in the parent trial (UPLIFT; NCT03074643): Lower protein / higher CHO diet for the 6-month weight loss phase. Exercise intervention months 0-6. Weight loss intervention months 0-6. Carbohydrate supplement for months 0-6 (blinded). Follow-up months 7-18.
arm group label: 6-mo HiProt
arm group type: Active Comparator
description: Subjects receiving the following interventions in the parent trial (UPLIFT; NCT03074643): Higher protein / lower CHO diet for the 6-month weight loss phase. Exercise intervention months 0-6. Weight loss intervention months 0-6. Protein supplement for months 0-6 (blinded). Follow-up months 7-18.
arm group label: 18-mo HiProt
arm group type: Active Comparator
description: Subjects receiving the following interventions in the parent trial (UPLIFT; NCT03074643):
Higher protein / lower CHO diet for the 6-month weight loss and 12-month follow-up phases. Exercise intervention months 0-6. Weight loss intervention months 0-6. Protein supplement for months 0-6 (blinded). Protein supplement for follow-up months 7-18.
intervention type: Behavioral
intervention name: Weight loss intervention months 0-6
description: All participants will undergo a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The weight loss intervention will incorporate nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions will be held weekly in a 3:1 ratio (3 group and 1 individual session per month).
arm group label: 18-mo HiProt
arm group label: 6-mo HiProt
arm group label: RecProt
intervention type: Behavioral
intervention name: Exercise intervention months 0-6
description: All participants will be expected to participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (e.g., treadmill walking) 3 days/wk during the 6-month weight loss intervention in accordance with the American Heart Association and the American College of Sports Medicine physical activity recommendations for older adults.
arm group label: 18-mo HiProt
arm group label: 6-mo HiProt
arm group label: RecProt
intervention type: Dietary Supplement
intervention name: NutraBio™ CarboMax Supplement
description: Participants in the lower protein / higher CHO diet group (RecProt) will be provided a carbohydrate supplement (NutraBio™ CarboMax, ~50 g of carbohydrate and 220 calories) to consume daily during the 6 month weight loss intervention.
arm group label: RecProt
intervention type: Dietary Supplement
intervention name: 6-month NutraBio™ 100% Whey Protein Isolate Supplement
description: Participants in the 6-month higher protein / lower CHO diet group (6-mo HiProt) will be provided a protein supplement (NutraBio™ 100% Whey Protein Isolate, ~50 g of protein and 220 calories) to consume daily during the 6 month weight loss intervention.
arm group label: 6-mo HiProt
intervention type: Dietary Supplement
intervention name: 18-month NutraBio™ 100% Whey Protein Isolate Supplement
description: Participants in the 18-month higher protein / lower CHO diet (18-mo HiProt) will be provided a protein supplement (NutraBio™ 100% Whey Protein Isolate, ~50 g of protein and 220 calories) to consume daily during the 6 month weight loss intervention and the 12-month follow-up.
arm group label: 18-mo HiProt
criteria: 
gender: All
minimum age: 65 Years
maximum age: 85 Years
healthy volunteers: No
last name: Ashley Weaver, PhD
role: Principal Investigator
affiliation: Wake Forest University Health Sciences
facility: 
country: United States
responsible party type: Sponsor
mesh term: Osteoporosis
mesh term: Bone Diseases, Metabolic
mesh term: Body Weight
mesh term: Weight Loss
mesh term: Body Weight Changes
mesh term: Fractures, Bone
sharing ipd: No
provided document: 