Overview

This trial is active, not recruiting.

Conditions obesity, menopause, osteoporosis, sarcopenia
Treatments weight loss with normal protein and leucine intake, weight loss with protein/leucine supplementation
Sponsor Washington University School of Medicine
Collaborator Ajinomoto Co., Inc.
Start date September 2012
End date December 2016
Trial size 75 participants
Trial identifier NCT01757340, CRL-201102153

Summary

The purpose of this study is to determine whether consuming additional leucine during calorie restriction induced weight loss has beneficial or harmful effects on multi-organ (liver, muscle, adipose tissue) insulin sensitivity, colonocyte proliferation rates, the gut microbiome, muscle mass and function, and bone mineral density in obese, postmenopausal women.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(No Intervention)
Weight maintenance with normal protein and leucine intake
(Active Comparator)
weight loss with normal protein and leucine intake
Goal of 8 to 10% weight loss while consuming the recommended daily allowance of protein (i.e, 0.8 grams of protein per kg body weight per day).
(Experimental)
weight loss with protein/leucine supplementation
Goal of 8 to 10% weight loss while consuming 150% of the recommended daily allowance of protein (i.e., 1.2 grams of protein per kg body weight per day) with the additional protein given in the form of whey protein, which has a high leucine content.

Primary Outcomes

Measure
Change in muscle mass
time frame: Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group
Change in muscle strength
time frame: Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group
Change in bone mineral density and bone mineral content
time frame: Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group

Secondary Outcomes

Measure
Change in skeletal muscle insulin sensitivity
time frame: Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group
Change in bacterial populations found in the stool
time frame: Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group
Change in cell proliferation (growth) rates in the colon
time frame: Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group
Determine the acute effect of leucine ingestion on skeletal muscle insulin sensitivity
time frame: Prior to starting the weight loss or maintenance intervention
Determine the acute effect of leucine ingestion on muscle protein metabolism
time frame: Prior to starting the weight loss or maintenance intervention

Eligibility Criteria

Female participants from 50 years up to 65 years old.

Inclusion Criteria: - Obese with body mass index (BMI) between 30 and 40 kg/m2 - Postmenopausal - Sedentary (i.e., less than 1.5 hours of exercise per week) Exclusion Criteria: - Individuals with diabetes and/or uncontrolled hypertension - Individuals with hepatitis B and/or C - Individuals who smoke - Individuals with an allergy to whey protein

Additional Information

Official title Calorie Restriction With Leucine Supplementation in Postmenopausal Women
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Washington University School of Medicine.