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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01757340
Other study ID # CRL-201102153
Secondary ID
Status Completed
Phase N/A
First received December 14, 2012
Last updated March 24, 2017
Start date September 2012
Est. completion date March 2017

Study information

Verified date March 2017
Source Washington University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 43
Est. completion date March 2017
Est. primary completion date March 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 50 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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).
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.

Locations

Country Name City State
United States Washington University School of Medicine Saint Louis Missouri

Sponsors (2)

Lead Sponsor Collaborator
Washington University School of Medicine Ajinomoto Co., Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Smith GI, Yoshino J, Stromsdorfer KL, Klein SJ, Magkos F, Reeds DN, Klein S, Mittendorfer B. Protein Ingestion Induces Muscle Insulin Resistance Independent of Leucine-Mediated mTOR Activation. Diabetes. 2015 May;64(5):1555-63. doi: 10.2337/db14-1279. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in muscle mass 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) Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group
Primary Change in muscle strength We will evaluate muscle strength by administering maximum one repetition strength and isokinetic strength tests. Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group
Primary Change in bone mineral density and bone mineral content We will evaluate total bone mass and total body and regional bone mineral density by using dual X-ray energy absorptiometry (DXA). Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group
Secondary Change in skeletal muscle insulin sensitivity We will evaluate insulin sensitivity using the hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotope labeled tracer infusions Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group
Secondary 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
Secondary Change in cell proliferation (growth) rates in the colon We will examine colon cell proliferation rates using stable isotope labelled tracer methods in conjunction with sigmoid colon biopsy samples Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group
Secondary Determine the acute effect of leucine ingestion on skeletal muscle insulin sensitivity We will evaluate insulin sensitivity using the hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotope labeled tracer infusions Prior to starting the weight loss or maintenance intervention
Secondary Determine the acute effect of leucine ingestion on muscle protein metabolism 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. Prior to starting the weight loss or maintenance intervention
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