Calorie Restriction With Leucine Supplementation

Obesity Clinical Trial

Official title:

Calorie Restriction With Leucine Supplementation in Postmenopausal Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01757340
• Other study ID #: CRL-201102153
• 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
• 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

Related Conditions & MeSH terms

• Menopause
• Obesity
• Osteoporosis
• Sarcopenia

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