Status:
COMPLETED
Utilizing Protein During Weight Loss to Impact Physical Function and Bone
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Obesity
Weight Loss
Eligibility:
All Genders
65-85 years
Phase:
NA
Brief Summary
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 prote...
Detailed Description
The ancillary study to the UPLIFT trial (NCT03074643) will use a 3-group design in 225 obese (body mass index \[BMI\] 30-45 kg/m2 or 27-\<30 kg/m2 with an obesity-related risk factor), older (65-85 ye...
Eligibility Criteria
Inclusion
- Subjects are recruited using inclusion and exclusion criteria of the parent trial (UPLIFT; NCT03074643).
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 3 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 28 2022
Estimated Enrollment :
187 Patients enrolled
Trial Details
Trial ID
NCT03819478
Start Date
May 3 2017
End Date
April 28 2022
Last Update
January 19 2024
Active Locations (1)
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1
Geriatric Research Center at Wake Forest Baptist Health
Winston-Salem, North Carolina, United States, 27157