CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 187 enrolled
Drug / intervention
Weight loss intervention months 0-6 +4 morebehavioral
Likely dose
Protein supplement ~50 g protein daily (or carbohydrate supplement ~50 g daily for control group) for 6 months; protein supplement group continues for additional 12 monthsAI-extracted
Key inclusion· 6
  • ✓Age 65-85 years
  • ✓BMI 27-45 kg/m²
  • ✓Low physical function: eSPPB <2.5
  • ✓No regular resistance or aerobic exercise (>20 min/day) in past 6 months
Key exclusion· 14
  • ✕Weight loss ≥5% in past 6 months
  • ✕Dependent on cane or walker
  • ✕Cognitive impairment (MoCA score <22)
  • ✕Severe arthritis or other musculoskeletal disorder

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

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NCT03074643N/ACompleted
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Long-term Effects of Weight Loss and Supplemental Protein on Physical Function

Wake Forest University Health Sciences·interventional·Posted Mar 9, 2017·Updated May 22, 2023

In Brief

A clinical study evaluating Weight loss intervention months 0-6, Exercise intervention months 0-6, and 3 other interventions for Obesity and 5 related conditions. Completed, enrolled 187 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity, Weight Loss, Diet Modification, Aging, Weight Change, Body, Dietary Habits
CountriesUnited States
CollaboratorsNational Institute on Aging (NIA)

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedMar 9, 2017
Enrollment StartMay 3, 2017
Primary CompletionApr 28, 2022
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 9.3 years ago

Interventions

Weight loss intervention months 0-6behavioral

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).

Exercise intervention months 0-6behavioral

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.

Carbohydrate supplement for months 0-6dietary

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.

Protein supplement for months 0-6dietary

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.

Protein supplement for follow-up months 7-18dietary

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.