Utilizing Protein During Weight Loss to Impact Physical Function and Bone

Completed · Not applicable

Conditions studied: Obesity, Weight Loss, Diet Modification, Aging, Weight Change, Body, Dietary Habits, Osteopenia, Osteoporosis, Bone Loss, Fractures, Bone

In brief

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.

Key facts

Study ID

NCT03819478

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

2024-01-19

Who can join

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

You may qualify if…

• 65-85 years
• BMI: 30-45 kg/m2 or BMI 27.0 - <30.0 AND at least one of the following risk factors:
• elevated waist circumference (>35 inches in women, >40 inches in men)
• diabetes,
• hypertension,
• dyslipidemia,
• or other obesity-related comorbidities: clinically manifest coronary artery disease [e.g., history of myocardial infarction, angina pectoris, coronary artery surgery, coronary artery procedures (e.g., angioplasty) if not within the past year], other atherosclerotic disease [e.g., peripheral arterial disease, abdominal aortic aneurysm, symptomatic carotid artery disease if not within the past year], sleep apnea, or osteoarthritis of the knee or hip.
• No regular resistance training and/or aerobic exercise (>20 mins/d) for past 6 months
• SPPB ≥3 to ≤10
• 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 (Montreal Cognitive Assessment, MoCA score <22)
• Severe arthritis, or other musculoskeletal disorder
• Joint replacement or other orthopedic surgery in past year
• Uncontrolled resting hypertension (>160/90 mmHg);
• Uncontrolled diabetes (hemoglobin A1c, HbA1c ≥8.0%)
• 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 (estimated glomerular rate <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
• Protein supplements (and unwilling to stop using for duration of study)
• 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

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.