Skip to main content
OpenTrials
Completed

NCT Number: NCT01497106

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Insulin Resistance Body Weight Glucose Metabolism Disorders Hyperinsulinism Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Abdominal Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Calorie Restriction

Behavioral

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)

Behavioral

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 outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Dec 22, 2011
Registry last updated
Nov 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.