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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01497106
First Posted: December 22, 2011
Last Update Posted: November 26, 2014
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.
Information provided by (Responsible Party):
K. Sreekumaran Nair, Mayo Clinic
  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: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effects of Calorie Restriction on Accumulation of Old, Modified Proteins in Abdominally Obese Adults

Further study details as provided by K. Sreekumaran Nair, 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 ]
    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 ]
    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.


Enrollment: 29
Study Start Date: December 2011
Study Completion Date: November 2014
Primary Completion Date: November 2014 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: K. Sreekumaran Nair, M.D., Ph.D. Mayo Clinic
  More Information

Responsible Party: K. Sreekumaran Nair, Professor of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01497106     History of Changes
Other Study ID Numbers: 11-006181
First Submitted: December 16, 2011
First Posted: December 22, 2011
Last Update Posted: November 26, 2014
Last Verified: November 2014

Keywords provided by K. Sreekumaran Nair, Mayo Clinic:
Insulin resistance
Abdominal obesity
Calorie restriction

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