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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01497106
Recruitment Status : Completed
First Posted : December 22, 2011
Last Update Posted : November 26, 2014
Sponsor:
Information provided by (Responsible Party):
K. Sreekumaran Nair, Mayo Clinic

Tracking Information
First Submitted Date  ICMJE December 16, 2011
First Posted Date  ICMJE December 22, 2011
Last Update Posted Date November 26, 2014
Study Start Date  ICMJE December 2011
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2011)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2011)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Calorie Restriction on Accumulation of Old, Modified Proteins in Abdominally Obese Adults
Official Title  ICMJE Effects of Calorie Restriction on Accumulation of Old, Modified Proteins in Abdominally Obese Adults
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Insulin Resistance
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Calorie Restriction
  • Active Comparator: Control
    Participants will continue their normal living for entire time of the study, totaling 16 weeks.
    Intervention: Behavioral: Control (normal living)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 25, 2014)
29
Original Estimated Enrollment  ICMJE
 (submitted: December 21, 2011)
40
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01497106
Other Study ID Numbers  ICMJE 11-006181
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party K. Sreekumaran Nair, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: K. Sreekumaran Nair, M.D., Ph.D. Mayo Clinic
PRS Account Mayo Clinic
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP