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

This study is currently recruiting participants.
Verified November 2012 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: November 7, 2012
Last verified: November 2012
History of Changes
  Purpose

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


Condition Intervention
Insulin Resistance
 Behavioral: Calorie Restriction
Behavioral: Control (normal living)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Effects of Calorie Restriction on Accumulation of Old, Modified Proteins in Abdominally Obese Adults

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 40
Study Start Date: December 2011
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01497106

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States
Contact: Deborah Sheldon     507-255-8082        
Principal Investigator: K. Sreekumaran Nair, M.D., Ph.D.            
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: K. Sreekumaran Nair, M.D., Ph.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: K. Sreekumaran Nair, Professor of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01497106     History of Changes
Other Study ID Numbers: 11-006181
Study First Received: December 16, 2011
Last Updated: November 7, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Insulin resistance
Abdominal obesity
Calorie restriction

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 21, 2013