Calorie Restriction With Leucine Supplementation - Full Text View

Purpose

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.

Condition	Intervention
Obesity Menopause Osteoporosis Sarcopenia	Behavioral: Weight loss with normal protein and leucine intake Behavioral: Weight loss with protein/leucine supplementation

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Calorie Restriction With Leucine Supplementation in Postmenopausal Women

Resource links provided by NLM:

MedlinePlus related topics: Bone Density Diabetes Medicines Menopause Minerals Obesity Osteoporosis Weight Control

Drug Information available for: Leucine

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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)
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 ] [ Designated as safety issue: No ]
We will evaluate muscle strength by administering maximum one repetition strength and isokinetic strength tests.
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 ] [ Designated as safety issue: No ]
We will evaluate total bone mass and total body and regional bone mineral density by using dual X-ray energy absorptiometry (DXA).

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
We will evaluate insulin sensitivity using the hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotope labeled tracer infusions
Change in skeletal muscle protein metabolism [ Time Frame: Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group ] [ Designated as safety issue: No ]
We will assess rates of muscle protein synthesis, breakdown and net protein balance during postabsorptive conditions and when insulin and/or amino acid concentrations are elevated using stable isotope labeled tracer methods
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
We will examine colon cell proliferation rates using stable isotope labelled tracer methods in conjunction with sigmoid colon biopsy samples
Determine the acute effect of leucine ingestion on skeletal muscle insulin sensitivity [ Time Frame: Prior to starting the weight loss or maintenance intervention) ] [ Designated as safety issue: No ]
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 [ Time Frame: Prior to starting the weight loss or maintenance intervention) ] [ Designated as safety issue: No ]
We will assess rates of muscle protein synthesis, breakdown and net protein balance during postabsorptive conditions and when insulin and/or amino acid concentrations are elevated using stable isotope labeled tracer methods
Change in skeletal muscle insulin sensitivity [ Time Frame: Baseline and after 5% weight loss in the calorie restriction groups and ~3 months in the weight maintenance group ] [ Designated as safety issue: No ]
We will evaluate insulin sensitivity using the hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotope labeled tracer infusions
Change in skeletal muscle protein metabolism [ Time Frame: Baseline and after 5% weight loss in the calorie restriction groups and ~3 months in the weight maintenance group ] [ Designated as safety issue: No ]
We will assess rates of muscle protein synthesis, breakdown and net protein balance during postabsorptive conditions and when insulin and/or amino acid concentrations are elevated using stable isotope labeled tracer methods

Estimated Enrollment:	75
Study Start Date:	September 2012
Estimated Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: Weight maintenance Weight maintenance with normal protein and leucine intake
Active Comparator: Weight loss with normal protein intake	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).
Experimental: Weight loss with leucine supplementation	Behavioral: 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.

Eligibility

Ages Eligible for Study:	50 Years to 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01757340

Contacts

Contact: Janet Winkelmann, CMA	314-286-2080	jwinkelm@dom.wustl.edu
Contact: Emily Lake, BGS	314-747-3758	lakeem@wusm.wustl.edu

Locations

United States, Missouri
Washington University School of Medicine	Recruiting
Saint Louis, Missouri, United States, 63110
Principal Investigator: Bettina Mittendorfer, PhD

Sponsors and Collaborators

Washington University School of Medicine

AJINOMOTO Co., Inc., Japan

More Information

No publications provided

Responsible Party:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT01757340 History of Changes
Other Study ID Numbers:	CRL-201102153
Study First Received:	December 14, 2012
Last Updated:	January 8, 2013
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Obesity
Osteoporosis
Sarcopenia
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Bone Diseases, Metabolic

Bone Diseases
Musculoskeletal Diseases
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 23, 2013