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Completed

NCT Number: NCT01538836

Calorie Restriction, Protein Supplementation and Metabolic Health

The purpose of this study is to determine whether consuming additional protein 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 50 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 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 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).

Primary outcomes

  1. Change in muscle volume

    Time frame: Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group

    Thigh muscle volume will be measured 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

    Muscle strength will be evaluated by administering maximum one repetition strength and isokinetic strength tests.

  3. Changes 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

    Total bone mass and total body and regional bone mineral density will be evaluated by using dual X-ray energy absorptiometry (DXA).

Secondary outcomes

  1. Change in insulin sensitivity

    Time frame: Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group

    Insulin sensitivity (glucose rate of disappearance [Rd] during a hyperinsulinemic-euglycemic clamp procedure) will be evaluated in a subset of 10 participants per group because power analysis has determined that this number is sufficient to detect a 25% difference between groups assuming 80% power, an alpha value of 0.05 and an average baseline insulin-stimulated glucose Rd of 2,590 ± 492 µmol/min, the average ± SD insulin stimulated glucose Rd the investigators have measured during the past 20 y in obese subjects. In the investigators' experience (Kirk et al., 2009 and Magkos et al., 2016), the weight loss induced increase in insulin stimulated glucose Rd is ~50%.

  2. Change in muscle protein metabolism

    Time frame: Baseline and at 5% weight loss in the calorie restriction groups and after ~3 months in the weight maintenance group

    Rates of muscle protein synthesis, breakdown and net protein balance will be assessed during postabsorptive conditions and when insulin and/or amino acid concentrations are elevated.

  3. 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

  4. 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

    Colon cell proliferation rates will be determined using stable isotope labelled tracer methods in conjunction with sigmoid colon biopsy samples

  5. Determine the acute effect of whey protein ingestion on skeletal muscle insulin sensitivity

    Time frame: Prior to starting the weight loss or maintenance intervention

    Insulin sensitivity will be evaluated using the hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotope labeled tracer infusions

  6. Determine the acute effect of whey protein ingestion on muscle protein metabolism

    Time frame: Prior to starting the weight loss or maintenance intervention

    Rates of muscle protein synthesis, breakdown and net protein balance will be assessed using stable isotope labeled tracer methods during postabsorptive conditions and during insulin infusion with or without whey protein ingestion

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Calorie Restriction and Metabolic Health

Acronym: CRPS

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Feb 24, 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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