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Utilizing Protein During Weight Loss to Impact Physical Function (UPLIFT)

Primary Purpose

Obesity, Weight Loss, Diet Modification

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weight loss intervention months 0-6
Exercise intervention months 0-6
Carbohydrate supplement for months 0-6
Protein supplement for months 0-6
Protein supplement for follow-up months 7-18
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 65-85 years
  • BMI: 27-45 kg/m2
  • No regular resistance training and/or aerobic exercise (>20 mins/d) for past 6 months
  • eSPPB <2.5
  • No contraindications for safe and optimal participation in exercise training
  • Approved for participation by Medical Director (Dr. Lyles)
  • Willing to provide informed consent
  • Agree to all study procedures and assessments
  • Willing to consume protein/CHO supplements for up to 18 months
  • Able to provide own transportation to study visits and intervention sessions

Exclusion Criteria:

  • Weight loss (≥5%) in past 6 months
  • Dependent on cane or walker
  • Cognitive impairment (MoCA score <22)
  • Severe arthritis, or other musculoskeletal disorder
  • Joint replacement or other orthopedic surgery in past 6 months
  • Uncontrolled resting hypertension (>160/90 mmHg);
  • Insulin-dependent or uncontrolled diabetes (HbA1c ≥8%)
  • Current or recent past (within 1 year) severe symptomatic heart disease, uncontrolled angina, stroke, chronic respiratory disease requiring oxygen; uncontrolled endocrine/metabolic disease; neurological or hematological disease; cancer requiring treatment in past year, except non-melanoma skin cancers; liver or renal disease; or clinically evident edema
  • Unstable, severe depression
  • Serious conduction disorder, uncontrolled arrhythmia, or new Q waves or ST-segment depressions (>3 mm at rest or ≥2 mm with exercise)
  • Abnormal kidney function (eGFR <30 based on serum creatinine, age, gender, and race)
  • Anemia (Hb<13 g/dL in men; <12 g/dL in women)
  • Drug abuse or excessive alcohol use (>7 drinks/week women; >14 drinks/week men)
  • Use of any tobacco or nicotine products in the past year
  • Osteoporosis (T-score < -2.5 on hip or spine scan)
  • Regular use of growth/steroid hormones, sex steroids or corticosteroids, osteoporosis medication, or protein supplements
  • Weight loss medications or procedures
  • Current participation in another intervention study

Sites / Locations

  • Geriatric Research Center at Wake Forest Baptist Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

RecProt

6-mon HiProt

18-mon HiProt

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Change in Expanded Short Physical Performance Battery Score
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 change in lower extremity physical function assessed by the expanded Short Physical Performance Battery score over 18 months. The expanded Short Physical Performance Battery score ranges from 0 to 4 with higher scores indicating better lower extremity physical function

Secondary Outcome Measures

Lower Extremity Muscle Strength
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 change in lower extremity muscle strength assessed using an isokinetic dynamometer (Biodex) over 18 months
Weight Change
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 change in body weight over 18 months
Total Body Lean Mass
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 change in dual energy x-ray (DXA) acquired total body lean mass over 18 months
Total Body Fat Mass
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 change in dual energy x-ray acquired (DXA) total body fat mass over 18 months
Thigh Muscle Volume
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 change in computerized tomography (CT) acquired thigh muscle volume over 18 months
Intermuscular Adipose Tissue
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 change in computerized tomography (CT) acquired thigh intermuscular adipose tissue over 18 months

Full Information

First Posted
February 28, 2017
Last Updated
May 19, 2023
Sponsor
Wake Forest University Health Sciences
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT03074643
Brief Title
Utilizing Protein During Weight Loss to Impact Physical Function
Acronym
UPLIFT
Official Title
Long-term Effects of Weight Loss and Supplemental Protein on Physical Function
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
May 3, 2017 (Actual)
Primary Completion Date
April 28, 2022 (Actual)
Study Completion Date
April 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will 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 physical function, muscle mass, and weight loss maintenance in obese older adults. Participants will receive either a protein or carbohydrate supplement along with a behavioral weight loss intervention.
Detailed Description
The study will use a 3-group design in 225 obese (BMI 27-45 kg/m2), older (65-85 years) men and women at risk for disability (eSPPB <2.5) 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 wt/d) / lower carbohydrate (CHO) diet during a 6-month weight loss intervention improves physical function 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 improved physical function. 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). Physical function (primary aim) will be assessed by the expanded Short Physical Performance Battery (primary outcome) and lower extremity muscle strength at baseline, 6-, 12- and 18-months. Weight loss maintenance and body composition (secondary aim) will be assessed by dual-energy X-ray absorptiometry (DXA) and computed tomography (CT) at baseline, 6- and 18-months. Bone mineral density (DXA) and cardiometabolic risk factors will also be measured at baseline, 6- and 18-months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Weight Loss, Diet Modification, Aging, Weight Change, Body, Dietary Habits

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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).
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
187 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RecProt
Arm Type
Placebo Comparator
Arm Description
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 Title
6-mon HiProt
Arm Type
Active Comparator
Arm Description
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 Title
18-mon HiProt
Arm Type
Active Comparator
Arm Description
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(s)
Weight loss intervention months 0-6
Intervention 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).
Intervention Type
Behavioral
Intervention Name(s)
Exercise intervention months 0-6
Intervention 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Carbohydrate supplement for months 0-6
Intervention Description
Participants in the lower protein / higher CHO diet group (RecProt) will be provided a carbohydrate supplement (~50 g of carbohydrate and 220 calories) to consume daily during the 6 month weight loss intervention.
Intervention Type
Dietary Supplement
Intervention Name(s)
Protein supplement for months 0-6
Intervention Description
Participants in the higher protein / lower CHO diet groups (6-mon HiProt and 18-mon HiProt) will be provided a protein supplement (~50 g of protein and 220 calories) to consume daily during the 6 month weight loss intervention.
Intervention Type
Dietary Supplement
Intervention Name(s)
Protein supplement for follow-up months 7-18
Intervention Description
Participants in the higher protein / lower CHO diet (18-mon HiProt) will be provided a protein supplement (~50 g of protein and 220 calories) to consume daily during the 12-month follow-up.
Primary Outcome Measure Information:
Title
Change in Expanded Short Physical Performance Battery Score
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 change in lower extremity physical function assessed by the expanded Short Physical Performance Battery score over 18 months. The expanded Short Physical Performance Battery score ranges from 0 to 4 with higher scores indicating better lower extremity physical function
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Lower Extremity Muscle Strength
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 change in lower extremity muscle strength assessed using an isokinetic dynamometer (Biodex) over 18 months
Time Frame
18 months
Title
Weight Change
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 change in body weight over 18 months
Time Frame
18 months
Title
Total Body Lean Mass
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 change in dual energy x-ray (DXA) acquired total body lean mass over 18 months
Time Frame
18 months
Title
Total Body Fat Mass
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 change in dual energy x-ray acquired (DXA) total body fat mass over 18 months
Time Frame
18 months
Title
Thigh Muscle Volume
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 change in computerized tomography (CT) acquired thigh muscle volume over 18 months
Time Frame
18 months
Title
Intermuscular Adipose Tissue
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 change in computerized tomography (CT) acquired thigh intermuscular adipose tissue over 18 months
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 65-85 years BMI: 27-45 kg/m2 No regular resistance training and/or aerobic exercise (>20 mins/d) for past 6 months eSPPB <2.5 No contraindications for safe and optimal participation in exercise training Approved for participation by Medical Director (Dr. Lyles) Willing to provide informed consent Agree to all study procedures and assessments Willing to consume protein/CHO supplements for up to 18 months Able to provide own transportation to study visits and intervention sessions Exclusion Criteria: Weight loss (≥5%) in past 6 months Dependent on cane or walker Cognitive impairment (MoCA score <22) Severe arthritis, or other musculoskeletal disorder Joint replacement or other orthopedic surgery in past 6 months Uncontrolled resting hypertension (>160/90 mmHg); Insulin-dependent or uncontrolled diabetes (HbA1c ≥8%) Current or recent past (within 1 year) severe symptomatic heart disease, uncontrolled angina, stroke, chronic respiratory disease requiring oxygen; uncontrolled endocrine/metabolic disease; neurological or hematological disease; cancer requiring treatment in past year, except non-melanoma skin cancers; liver or renal disease; or clinically evident edema Unstable, severe depression Serious conduction disorder, uncontrolled arrhythmia, or new Q waves or ST-segment depressions (>3 mm at rest or ≥2 mm with exercise) Abnormal kidney function (eGFR <30 based on serum creatinine, age, gender, and race) Anemia (Hb<13 g/dL in men; <12 g/dL in women) Drug abuse or excessive alcohol use (>7 drinks/week women; >14 drinks/week men) Use of any tobacco or nicotine products in the past year Osteoporosis (T-score < -2.5 on hip or spine scan) Regular use of growth/steroid hormones, sex steroids or corticosteroids, osteoporosis medication, or protein supplements Weight loss medications or procedures Current participation in another intervention study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denise Houston, PhD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geriatric Research Center at Wake Forest Baptist Health
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Utilizing Protein During Weight Loss to Impact Physical Function

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