Overview

This trial is active, not recruiting.

Conditions weight loss, obesity
Treatments protein supplementation, diet counseling and group education lessons
Sponsor Duke University
Collaborator National Pork Board
Start date March 2014
End date May 2018
Trial size 80 participants
Trial identifier NCT02033655, Pro00050540

Summary

The purpose of the trial is to assess the effects of combining regular, generous intakes of high quality protein (primarily from lean pork and other animal source proteins) with calorie restriction on functional status and lean muscle mass in frail, obese, women who participate in a 6 month intervention and 9 month intervention.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Protein supplementation. Subjects follow a calorie-reduction diet for a weight loss of ≥10%, with a high proportion of protein, including substantial amounts of supplemental protein provided as lean beef. Intakes of > 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% of animal protein from pork.
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 lean pork.
diet counseling and group education lessons
Participants meet once a week for 6 months to participate in group lessons and counseling.
(Active Comparator)
Diet counseling and group education lessons. Subjects follow a calorie-reduction diet for a weight loss of ≥10%.
diet counseling and group education lessons
Participants meet once a week for 6 months to participate in group lessons and counseling.

Primary Outcomes

Measure
Physical function
time frame: Baseline, 4, 6, and 9 months
Lean Mass
time frame: Baseline, 4, 6, and 9 months

Secondary Outcomes

Measure
Physical Function
time frame: Baseline, 4, 6, and 9 months
Weight Loss
time frame: Baseline, 4, 6, and 9 months
Fat Mass
time frame: Baseline, 4, 6, and 9 months

Eligibility Criteria

Female participants at least 45 years old.

Inclusion Criteria: - Age 45+ yrs. - BMI of >30 kg/m2 - Body weight <495 lbs. - Normal blood chemistries - Normal renal function - Primary care physician acknowledgement - Non-Vegetarian - Mild to moderate movement impairment Exclusion Criteria: - Body weight >495 pounds. - Current smoker. - Presence of unstable, acutely symptomatic, or life-limiting illness. - Positive screen for dementia using Mini-Cog evaluation tool. - Neurological conditions causing functional or cognitive impairments. - History of significant weight instability (defined as > 10 pounds weight gain or loss over 6 months prior to study participation). - Unwillingness or inability to be randomized to any one of two intervention groups, submit to all study testing or continuously participate in a randomly assigned lifestyle intervention program for six months. - Inability to walk independently. - Bilateral hip replacements. - Unable to give consent. - Unable to complete written recording forms including journals of eating and exercise behaviors. - Current use of the following medications: monoamine oxidase inhibitors, prescription weight loss medications. - Primary Care Physician advises against participation.

Additional Information

Official title A High Protein Weight Loss Intervention for Sarcopenic Obesity in Women
Principal investigator Connie W Bales, PhD, RD
Description Assess the effects of combining regular, generous intakes of high quality protein (primarily from lean pork and other animal source proteins) with calorie restriction on functional status and lean muscle mass in frail, obese, women who participate in a 6 month intervention and 9 month intervention. For 6 month intervention: Participants will be randomized into one of two study arms: Weight Loss Control (n = 20) subjects follow a calorie-reduced diet for a weight loss or ≥10%; or Weight Loss-High Protein: (n = 40) 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 pork. Subject criteria will include obese (>30 kg/m2) women (≥ 45 yrs.) with mild to moderate functional impairment (by 6 minute walk). For 9 month intervention: Participants will be randomized into one of two study arms: Weight Loss Control (n = 10) subjects follow a calorie-reduced diet for a weight loss or ≥10%; or Weight Loss-High Protein: (n = 10) 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 pork. Subject criteria will include obese (≥ 30 kg/m2) women (≥ 60 yrs.) with mild to moderate functional impairment (by 6 minute walk). This is a randomized clinical trial with repeated measurements, with the purpose of assessing change over time for the overall sample and the difference in the High Protein group relative to the Control group with regards to primary outcomes (function and lean body mass). The statistical analyses will proceed chronologically in 3 phases: 1) descriptive analyses that will summarize the distribution of the covariates and dependent variables, 2) bivariate analyses of the association between group membership and the outcome measures, and 3) controlled multivariable analyses, which assess the association between experimental group and the outcomes, controlling for the important covariates.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Duke University.