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

Not Applicable

Completed

• Conditions: Insulin Resistance
• Interventions: Behavioral: Calorie Restriction; Behavioral: Control (normal living)

• Registration Number: NCT01497106
• Lead Sponsor: Mayo Clinic

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-16
• Study First Submitted QC: 2011-12-21
• Study First Posted: 2011-12-22
• Status Verified: 2014-11
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Last Update Submitted: 2014-11-25
• Last Update Posted: 2014-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Calorie restriction	Calorie Restriction	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.
Control	Control (normal living)	Participants will continue their normal living for entire time of the study, totaling 16 weeks.

Primary Outcome Measures

Name	Time	Method
Change in muscle protein synthesis from baseline to 16 weeks	Measured at week 0 (baseline) and week 16	The investigators will determine the rate of incorporation of stable isotope amino acid tracers in skeletal muscle protein on average resting muscle protein synthesis rate (% new muscle protein per hour) and will be performed at baseline and 16 weeks after caloric restriction or control diet.

Secondary Outcome Measures

Name	Time	Method
Change in insulin sensitivity from 0 (baseline) and 16 weeks	Measured at week 0 (baseline) and week 16	The investigators will determine insulin sensitivity at week 0 (baseline) and 16 weeks into caloric restriction or control diet. The measurement is made by hyperinsulimic euglycemic clamp and reported as μmol per kilogram of fat free mass of infused glucose needed to maintain glycemia.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States