A High Protein Weight Loss Intervention for Sarcopenic Obesity in Women

Not Applicable

Completed

• Conditions: Weight Loss; Obesity
• Interventions: Dietary Supplement: Protein supplementation; Behavioral: Diet counseling and group education lessons

• Registration Number: NCT02033655
• Lead Sponsor: Duke University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2014-01-09
• Study First Submitted QC: 2014-01-09
• Study First Posted: 2014-01-13
• Study Start: 2014-03
• Primary Completion: 2018-08-22
• Study Completion: 2018-08-22
• Status Verified: 2018-09
• Last Update Submitted: 2019-01-04
• Last Update Posted: 2019-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 105

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Weight loss high protein	Diet counseling and group education lessons	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.
Weight loss high protein	Protein supplementation	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.
Weight loss control	Diet counseling and group education lessons	Diet counseling and group education lessons. Subjects follow a calorie-reduction diet for a weight loss of ≥10%.

Primary Outcome Measures

Name	Time	Method
Physical function	Baseline, 4, 6, and 9 months	Assess the change in 6 minute walk scores at 4, 6, and 9 months
Lean Mass	Baseline, 4, 6, and 9 months	To assess the change in lean mass at 3 or 4 time points.

Secondary Outcome Measures

Name	Time	Method
Weight Loss	Baseline, 4, 6, and 9 months	To assess the change in body weight at 4, 6, and 9 months
Physical Function	Baseline, 4, 6, and 9 months	To assess the change in SPPB at 4, 6, and 9 months
Fat Mass	Baseline, 4, 6, and 9 months	To assess the change in fat mass at 4, 6, and 9 months

Trial Locations

Locations (1)

Duke Universtiy Medical Center; 🇺🇸 Durham, North Carolina, United States