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

Sponsor

Mayo Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT01497106

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Insulin Resistance	Behavioral: Calorie Restriction Behavioral: Control (normal living)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

29 participants

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

Study Start Date :

Dec 1, 2011

Actual Primary Completion Date :

Nov 1, 2014

Actual Study Completion Date :

Nov 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Change in muscle protein synthesis from baseline to 16 weeks [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator: K. Sreekumaran Nair, M.D., Ph.D., Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

K. Sreekumaran Nair, Professor of Medicine, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT01497106

Other Study ID Numbers:

11-006181

First Posted:

Dec 22, 2011

Last Update Posted:

Nov 26, 2014

Last Verified:

Nov 1, 2014

Keywords provided by K. Sreekumaran Nair, Professor of Medicine, Mayo Clinic

Insulin resistance

Abdominal obesity

Calorie restriction

Additional relevant MeSH terms:

Insulin Resistance

Study Results

No Results Posted as of Nov 26, 2014