Effects of Calorie Restriction on Accumulation of Old, Modified Proteins in Abdominally Obese Adults

Mayo Clinic

Status: Completed

Conditions: Insulin Resistance

Treatments: Behavioral: Calorie Restriction; Behavioral: Control (normal living)

Study type: Interventional

Funder types: Other

Identifiers

NCT01497106

11-006181

Details and patient eligibility

About

This study is being done to understand the effects of calorie restriction and weight loss on muscle protein metabolism in adult men and women.

Enrollment: 29 patients

Sex: All

Ages: 45 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy
• BMI will be between 30 kg/m2 - 38 kg/m2 and waist circumference for women ≥ 88 cm and men ≥ 104 cm
• Age 45 to 65 years.
• Male and Female

Exclusion criteria

• Active coronary artery disease
• BMI < 30 kg/m2 Participation in structured exercise (>2 times per week for 30 minutes or longer)
• Smoking
• Medications known to affect muscle metabolism (beta blockers)
• Renal failure (serum creatinine > 1.5mg/dl)
• Chronic active liver disease (AST and ALT > 3 times normal)
• Fasting blood glucose > 126 mg/dl
• Anti-coagulant therapy (warfarin/heparin)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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29 participants in 2 patient groups

Calorie restriction

Experimental group

Description:

Participants will work with the CRU dietetics staff to plan a diet that will result in their losing 1-2 pounds per week over 16 weeks.

Treatment:

Behavioral: Calorie Restriction

Control

Active Comparator group

Description:

Participants will continue their normal living for entire time of the study, totaling 16 weeks.

Treatment:

Behavioral: Control (normal living)