Utilizing Protein During Weight Loss to Impact Physical Function

Completed · Not applicable

Conditions studied: Obesity, Weight Loss, Diet Modification, Aging, Weight Change, Body, Dietary Habits

In brief

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.

Key facts

Study ID

NCT03074643

Run by

Wake Forest University Health Sciences

People needed

187

Starts

2017-05-03

Expected to finish

2022-04-28

Last updated by the study team

2023-05-22

Who can join

Age: 65 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

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)
• 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

Where it is running

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

Full record on ClinicalTrials.gov

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