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Calorie Restriction With Leucine Supplementation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01757340
First Posted: December 28, 2012
Last Update Posted: March 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ajinomoto Co., Inc.
Information provided by (Responsible Party):
Washington University School of Medicine
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]
    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 ]
    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 ]
    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 ]
    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 ]
  • 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 ]
    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 ]
    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 ]
    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.


Enrollment: 43
Actual Study Start Date: September 2012
Study Completion Date: March 2017
Primary Completion Date: March 2017 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 65 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01757340


Locations
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Ajinomoto Co., Inc.
  More Information

Publications:
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01757340     History of Changes
Other Study ID Numbers: CRL-201102153
First Submitted: December 14, 2012
First Posted: December 28, 2012
Last Update Posted: March 27, 2017
Last Verified: March 2017

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