Back to resultsEffects of Calorie Restriction on Accumulation of Old, Modified Proteins in Abdominally Obese Adults
Primary Purpose
Insulin Resistance
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Calorie Restriction
Control (normal living)
Sponsored by
About this trial
This is an interventional basic science trial for Insulin Resistance focused on measuring Insulin resistance, Abdominal obesity, Calorie restriction
Eligibility 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)
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Calorie restriction
Control
Arm Description
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.
Participants will continue their normal living for entire time of the study, totaling 16 weeks.
Outcomes
Primary Outcome Measures
Change in muscle protein synthesis from baseline to 16 weeks
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01497106
Brief Title
Effects of Calorie Restriction on Accumulation of Old, Modified Proteins in Abdominally Obese Adults
Official Title
Effects of Calorie Restriction on Accumulation of Old, Modified Proteins in Abdominally Obese Adults
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance
Keywords
Insulin resistance, Abdominal obesity, Calorie restriction
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Calorie restriction
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Participants will continue their normal living for entire time of the study, totaling 16 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Calorie Restriction
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control (normal living)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in muscle protein synthesis from baseline to 16 weeks
Description
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.
Time Frame
Measured at week 0 (baseline) and week 16
Secondary Outcome Measure Information:
Title
Change in insulin sensitivity from 0 (baseline) and 16 weeks
Description
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.
Time Frame
Measured at week 0 (baseline) and week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
K. Sreekumaran Nair, M.D., Ph.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
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Effects of Calorie Restriction on Accumulation of Old, Modified Proteins in Abdominally Obese Adults
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