Effects of Calorie Restriction on Accumulation of Old, Modified Proteins in Abdominally Obese Adults
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|ClinicalTrials.gov Identifier: NCT01497106|
Recruitment Status : Completed
First Posted : December 22, 2011
Last Update Posted : November 26, 2014
|Condition or disease||Intervention/treatment||Phase|
|Insulin Resistance||Behavioral: Calorie Restriction Behavioral: Control (normal living)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Effects of Calorie Restriction on Accumulation of Old, Modified Proteins in Abdominally Obese Adults|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||November 2014|
Experimental: 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.
Behavioral: 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. They will wear an accelerometer to track there activity during these weeks.
Active Comparator: Control
Participants will continue their normal living for entire time of the study, totaling 16 weeks.
Behavioral: Control (normal living)
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.
- Change in muscle protein synthesis from baseline to 16 weeks [ Time Frame: 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.
- Change in insulin sensitivity from 0 (baseline) and 16 weeks [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01497106
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||K. Sreekumaran Nair, M.D., Ph.D.||Mayo Clinic|