Calorie Restriction With Leucine Supplementation

The Washington University

Status: Completed

Conditions: Osteoporosis; Menopause; Obesity; Sarcopenia

Treatments: Behavioral: Weight loss with normal protein and leucine intake; Behavioral: Weight loss with protein/leucine supplementation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01757340

CRL-201102153

Details and patient eligibility

About

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.

Enrollment: 43 patients

Sex: Female

Ages: 50 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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43 participants in 3 patient groups

Weight maintenance

No Intervention group

Description:

Weight maintenance with normal protein and leucine intake

Weight loss with normal protein intake

Active Comparator group

Treatment:

Behavioral: Weight loss with normal protein and leucine intake

Weight loss with leucine supplementation

Experimental group

Treatment:

Behavioral: Weight loss with protein/leucine supplementation