Calorie Restriction With Leucine Supplementation

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Washington University School of Medicine
Sponsor:
Collaborator:
Ajinomoto Co., Inc.
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01757340
First received: December 14, 2012
Last updated: August 16, 2013
Last verified: August 2013
  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:


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 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 using stable isotope labeled tracer methods during postabsorptive conditions and during insulin infusion with or without leucine ingestion.


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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.
  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: August 16, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Osteoporosis
Sarcopenia
Atrophy
Bone Diseases
Bone Diseases, Metabolic
Muscular Atrophy
Musculoskeletal Diseases
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Manifestations
Pathological Conditions, Anatomical
Signs and Symptoms

ClinicalTrials.gov processed this record on October 30, 2014