Utilizing Protein During Weight Loss to Impact Physical Function
UPLIFT
Long-term Effects of Weight Loss and Supplemental Protein on Physical Function
2 other identifiers
interventional
187
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started May 2017
Longer than P75 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2017
CompletedFirst Posted
Study publicly available on registry
March 9, 2017
CompletedStudy Start
First participant enrolled
May 3, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 28, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 28, 2022
CompletedResults Posted
Study results publicly available
May 22, 2023
CompletedMay 22, 2023
April 1, 2023
5 years
February 28, 2017
April 24, 2023
May 19, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Lower Extremity Muscle Strength
18 months
Weight Change
18 months
Total Body Lean Mass
18 months
Total Body Fat Mass
18 months
Thigh Muscle Volume
18 months
- +1 more secondary outcomes
Study Arms (3)
RecProt
PLACEBO COMPARATORLower 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.
6-mon HiProt
ACTIVE COMPARATORHigher 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.
18-mon HiProt
ACTIVE COMPARATORHigher 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.
Interventions
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).
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Geriatric Research Center at Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
We initially planned to end recruitment in August of 2020. However, our institution paused all in-person research from March 13, 2020 through May 31, 2020 due to the COVID19 pandemic. We extended our recruitment window through September 2020 but did not reach our target enrollment. The COVID19 pandemic also affected participant follow-up (a large number of out of window visits and a few who refused to return for in-person visits). The 6-month intervention also had to go remote for \~4 months.
Results Point of Contact
- Title
- Dr. Denise Houston
- Organization
- Wake Forest University School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Denise Houston, PhD
Wake Forest University Health Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2017
First Posted
March 9, 2017
Study Start
May 3, 2017
Primary Completion
April 28, 2022
Study Completion
April 28, 2022
Last Updated
May 22, 2023
Results First Posted
May 22, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share