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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
K. Sreekumaran Nair, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01497106
First received: December 16, 2011
Last updated: April 9, 2014
Last verified: April 2014

December 16, 2011
April 9, 2014
December 2011
December 2014   (final data collection date for primary outcome measure)
Change in muscle protein synthesis from baseline to 16 weeks [ Time Frame: Measured at week 0 (baseline) and week 16 ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01497106 on ClinicalTrials.gov Archive Site
Change in insulin sensitivity from 0 (baseline) and 16 weeks [ Time Frame: Measured at week 0 (baseline) and week 16 ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
Effects of Calorie Restriction on Accumulation of Old, Modified Proteins in Abdominally Obese Adults
Effects of Calorie Restriction on Accumulation of Old, Modified Proteins in Abdominally Obese Adults

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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Insulin Resistance
  • 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.
  • 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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
December 2014
December 2014   (final data collection date for primary outcome measure)

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)
Both
45 Years to 65 Years
Yes
United States
 
NCT01497106
11-006181
No
K. Sreekumaran Nair, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: K. Sreekumaran Nair, M.D., Ph.D. Mayo Clinic
Mayo Clinic
April 2014

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