Menopause, Obesity, Osteoporosis, Sarcopenia
Conditions
Brief summary
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.
Interventions
BEHAVIORALWeight 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).
BEHAVIORALWeight 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.
Sponsors
Ajinomoto Co., Inc.
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in muscle mass | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Determine the acute effect of leucine ingestion on skeletal muscle insulin sensitivity | 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 |
| Change in skeletal muscle insulin sensitivity | 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 |
| Determine the acute effect of leucine ingestion on muscle protein metabolism | 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. |
| Change in bacterial populations found in the stool | 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 | 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 |
Countries
United States
Outcome results
None listed