Calorie Restriction, Protein Supplementation and Metabolic Health (CRPS)

The Washington University

Status: Completed

Conditions: Osteoporosis; Menopause; Obesity; Sarcopenia

Treatments: Behavioral: Weight loss with protein supplementation; Behavioral: Weight loss with normal protein intake

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01538836

CRPS-201107354

1R01DK094483-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: Female

Ages: 50 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 3 patient groups

Weight maintenance

No Intervention group

Description:

Weight maintenance with normal protein intake

Weight loss with normal protein intake

Active Comparator group

Treatment:

Behavioral: Weight loss with normal protein intake

Weight loss with protein supplementation

Experimental group

Treatment:

Behavioral: Weight loss with protein supplementation