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

Long-term Effects of Weight Loss and Supplemental Protein on Physical Function

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Weight Loss; Diet Modification; Aging; Dietary Habits; Weight Change, Body
• Intervention / Treatment: Behavioral: Weight loss intervention months 0-6; Behavioral: Exercise intervention months 0-6; Dietary supplement: Carbohydrate supplement for months 0-6; Dietary supplement: Protein supplement for months 0-6; Dietary supplement: Protein supplement for follow-up months 7-18

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.

• Study Type: Interventional
• Enrollment (Actual): 187
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Geriatric Research Center at Wake Forest Baptist Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 85 years (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: RecProt; 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.	Behavioral: Weight loss intervention months 0-6; 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).; Behavioral: Exercise intervention months 0-6; 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.; Dietary supplement: Carbohydrate supplement for months 0-6; 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.
Active Comparator: 6-mon HiProt; 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.	Behavioral: Weight loss intervention months 0-6; 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).; Behavioral: Exercise intervention months 0-6; 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.; Dietary supplement: Protein supplement for months 0-6; 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.
Active Comparator: 18-mon HiProt; 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.	Behavioral: Weight loss intervention months 0-6; 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).; Behavioral: Exercise intervention months 0-6; 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.; Dietary supplement: Protein supplement for months 0-6; 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.; Dietary supplement: Protein supplement for follow-up months 7-18; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	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	18 months

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Denise Houston, PhD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2017
• Primary Completion (Actual): April 28, 2022
• Study Completion (Actual): April 28, 2022

Study Registration Dates

• First Submitted: February 28, 2017
• First Submitted That Met QC Criteria: March 3, 2017
• First Posted (Actual): March 9, 2017

Study Record Updates

• Last Update Posted (Actual): May 22, 2023
• Last Update Submitted That Met QC Criteria: May 19, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Weight Loss; Body Weight; Body Weight Changes
• Other Study ID Numbers: IRB00038668 (Other Identifier: Wake Forest University IRB); R01AG050656 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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