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

Insulin Resistance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01497106
• Other study ID #: 11-006181
• Status: Completed
• Phase: N/A
• First received: December 16, 2011
• Last updated: November 25, 2014
• Start date: December 2011
• Est. completion date: November 2014

Study information

• Verified date: November 2014
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years to 65 Years

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Insulin Resistance

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Measured at week 0 (baseline) and week 16	No
Secondary	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.	Measured at week 0 (baseline) and week 16	No