Calorie Restriction With Leucine Supplementation

Not Applicable

Completed

• Conditions: Osteoporosis; Menopause; Sarcopenia; Obesity
• Interventions: Behavioral: Weight loss with normal protein and leucine intake; Behavioral: Weight loss with protein/leucine supplementation

• Registration Number: NCT01757340
• Lead Sponsor: Washington University School of Medicine

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-12-14
• Study First Submitted QC: 2012-12-20
• Study First Posted: 2012-12-28
• Status Verified: 2017-03
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Last Update Submitted: 2017-03-24
• Last Update Posted: 2017-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 43

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Weight loss with normal protein intake	Weight loss with normal protein and leucine intake	-
Weight loss with leucine supplementation	Weight loss with protein/leucine supplementation	-

Primary Outcome Measures

Name	Time	Method
Change in bone mineral density and bone mineral content	Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group	We will evaluate total bone mass and total body and regional bone mineral density by using dual X-ray energy absorptiometry (DXA).
Change in muscle strength	Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group	We will evaluate muscle strength by administering maximum one repetition strength and isokinetic strength tests.
Change in muscle mass	Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group	We will measure total appendicular skeletal muscle mass by using dual-energy X-ray absorptiometry (DXA) and thigh muscle volume by magnetic resonance imaging (MRI)

Secondary Outcome Measures

Name	Time	Method
Change in bacterial populations found in the stool	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	Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group	We will examine colon cell proliferation rates using stable isotope labelled tracer methods in conjunction with sigmoid colon biopsy samples
Change in skeletal muscle insulin sensitivity	Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group	We will evaluate insulin sensitivity using the hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotope labeled tracer infusions
Determine the acute effect of leucine ingestion on skeletal muscle insulin sensitivity	Prior to starting the weight loss or maintenance intervention	We will evaluate insulin sensitivity using the hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotope labeled tracer infusions
Determine the acute effect of leucine ingestion on muscle protein metabolism	Prior to starting the weight loss or maintenance intervention	We will assess rates of muscle protein synthesis, breakdown and net protein balance using stable isotope labeled tracer methods during postabsorptive conditions and during insulin infusion with or without leucine ingestion.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States