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

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

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

Conditions
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Insulin Resistance

Intervention / Treatment
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* Behavioral: Calorie Restriction
* Behavioral: Control (normal living)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Calorie restriction<br>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. | Behavioral: Calorie Restriction<br>* 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. They will wear an accelerometer to track there activity during these weeks.<br>|
| Active Comparator: Control<br>Participants will continue their normal living for entire time of the study, totaling 16 weeks. | Behavioral: Control (normal living)<br>* Participants will continue their normal living for entire time of the study. They will be asked to wear an accelerometer for the next 16 weeks and check in weekly at the CRU to exchange accelerometers.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in muscle protein synthesis from baseline to 16 weeks | 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. | Measured at week 0 (baseline) and week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in insulin sensitivity from 0 (baseline) and 16 weeks | 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. | Measured at week 0 (baseline) and week 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insulin resistance, Abdominal obesity, Calorie restriction