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

NCT01497106 | Completed

• 1 other identifier: 11-006181
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Insulin Resistance

Keywords

Insulin resistance; Abdominal obesity; Calorie restriction

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Change in insulin sensitivity from 0 (baseline) and 16 weeks

  Measured at week 0 (baseline) and week 16

Study Arms (2)

Calorie restriction

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

Participants will continue their normal living for entire time of the study, totaling 16 weeks.

Behavioral: Control (normal living)

Interventions

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.

Calorie restriction

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.

Control

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Insulin Resistance; Obesity, Abdominal

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• K. Sreekumaran Nair, M.D., Ph.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: December 16, 2011
• First Posted: December 22, 2011
• Study Start: December 1, 2011
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: November 26, 2014

Record last verified: 2014-11

Locations

US (1)