MedTrace Logo

Measuring Eating, Activity and Strength: Understanding the Response -Using Protein

NCT01715753 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2018-12-12

No results posted yet for this study

Summary

The purpose of the trial is to assess the effects of weight loss on functional status and lean muscle mass in frail, obese older adults (\>/= 60) who participate in a 6 month weight reduction intervention. Participants will be randomized into one of two study arms: Weight Loss Control: (n = 25) subjects follow a calorie-reduction diet for a weight loss of ≥10%; or Weight Loss-High Protein: (n = 50) subjects follow a calorie-reduction diet for a weight loss of ≥10%, with a high proportion of high quality protein at each meal. Intakes of \> 30g of high quality protein will be achieved three times a day by subjects in this group, predominantly all from animal sources and 60-70% of animal protein from beef. Subject criteria will include obese (\>30 kg/m2) older adults (\>60 yrs.) with mild to moderate functional impairment (by Short Physical Performance Battery; SPPB score \>/= 4)

Conditions

Interventions

DIETARY_SUPPLEMENT

Protein supplementation

\> 30g of high quality protein will be achieved three times a day by subjects in this group, with all or predominantly all from animal source and 60-70% of animal protein from beef.

BEHAVIORAL

Diet counseling and group education lessons

Individual and group diet counseling to achieve a \>10% weight loss

Sponsors & Collaborators

Principal Investigators

  • Connie W Bales, PhD, RD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01715753 on ClinicalTrials.gov