CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 187 enrolled
Drug / intervention
Weight loss intervention months 0-6 +4 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT03819478
NCT03819478N/ACompleted
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Effect of Protein Supplementation During Weight Loss on Older Adult Bone Health

Wake Forest University Health Sciences·interventional·Posted Jan 28, 2019·Updated Jan 19, 2024

In Brief

A clinical study evaluating Weight loss intervention months 0-6, Exercise intervention months 0-6, and 3 other interventions for Obesity and 8 related conditions. Completed, enrolled 187 participants across 1 site.

Detailed 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 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.

Study Details

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

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJan 28, 2019
Enrollment StartMay 3, 2017
Primary CompletionApr 28, 2022
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 7.4 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.

NutraBio™ CarboMax Supplementdietary

Participants in the lower protein / higher CHO diet group (RecProt) will be provided a carbohydrate supplement (NutraBio™ CarboMax, \~50 g of carbohydrate and 220 calories) to consume daily during the 6 month weight loss intervention.

6-month NutraBio™ 100% Whey Protein Isolate Supplementdietary

Participants in the 6-month higher protein / lower CHO diet group (6-mo HiProt) will be provided a protein supplement (NutraBio™ 100% Whey Protein Isolate, \~50 g of protein and 220 calories) to consume daily during the 6 month weight loss intervention.

18-month NutraBio™ 100% Whey Protein Isolate Supplementdietary

Participants in the 18-month higher protein / lower CHO diet (18-mo HiProt) will be provided a protein supplement (NutraBio™ 100% Whey Protein Isolate, \~50 g of protein and 220 calories) to consume daily during the 6 month weight loss intervention and the 12-month follow-up.