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Completed

NCT Number: NCT01757340

Calorie Restriction With Leucine Supplementation

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.

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Key information

Conditions

Obesity Atrophy Body Weight Bone Diseases Bone Diseases, Metabolic Menopause Metabolic Diseases Muscular Atrophy Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Osteoporosis Overnutrition Overweight Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms

Age range

50 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Weight loss with normal protein and leucine intake

Behavioral

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

Behavioral

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.

Primary outcomes

  1. 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)

  2. 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.

  3. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Ajinomoto Co., Inc.

Registry information

Official study title

Calorie Restriction With Leucine Supplementation in Postmenopausal Women

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Dec 28, 2012
Registry last updated
Mar 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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