Calorie Restriction, Protein Supplementation and Metabolic Health

Not Applicable

Completed

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

• Registration Number: NCT01538836
• Lead Sponsor: Washington University School of Medicine

Brief Summary

The purpose of this study is to determine whether consuming additional protein 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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-02-20
• Study First Submitted QC: 2012-02-20
• Study First Posted: 2012-02-24
• Status Verified: 2017-03
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Last Update Submitted: 2017-03-22
• Last Update Posted: 2017-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 75

Inclusion Criteria

• Obese with body mass index (BMI) between 30 and 50 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 intake	-
Weight loss with protein supplementation	Weight loss with protein supplementation	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in insulin sensitivity	Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group	Insulin sensitivity (glucose rate of disappearance \[Rd\] during a hyperinsulinemic-euglycemic clamp procedure) will be evaluated in a subset of 10 participants per group because power analysis has determined that this number is sufficient to detect a 25% difference between groups assuming 80% power, an alpha value of 0.05 and an average baseline insulin-stimulated glucose Rd of 2,590 ± 492 µmol/min, the average ± SD insulin stimulated glucose Rd the investigators have measured during the past 20 y in obese subjects. In the investigators' experience (Kirk et al., 2009 and Magkos et al., 2016), the weight loss induced increase in insulin stimulated glucose Rd is \~50%.
Change in muscle protein metabolism	Baseline and at 5% weight loss in the calorie restriction groups and after ~3 months in the weight maintenance group	Rates of muscle protein synthesis, breakdown and net protein balance will be assessed during postabsorptive conditions and when insulin and/or amino acid concentrations are elevated.
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	Colon cell proliferation rates will be determined using stable isotope labelled tracer methods in conjunction with sigmoid colon biopsy samples
Determine the acute effect of whey protein ingestion on skeletal muscle insulin sensitivity	Prior to starting the weight loss or maintenance intervention	Insulin sensitivity will be evaluated using the hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotope labeled tracer infusions
Determine the acute effect of whey protein ingestion on muscle protein metabolism	Prior to starting the weight loss or maintenance intervention	Rates of muscle protein synthesis, breakdown and net protein balance will be assessed using stable isotope labeled tracer methods during postabsorptive conditions and during insulin infusion with or without whey protein ingestion

Trial Locations

Locations (1)

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