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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01497106
Enrollment
29
Registered
2011-12-22
Start date
2011-12-31
Completion date
2014-11-30
Last updated
2014-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin Resistance

Keywords

Insulin resistance, Abdominal obesity, Calorie restriction

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.

Interventions

BEHAVIORALCalorie 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.

BEHAVIORALControl (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.

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
45 Years to 65 Years
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)

Design outcomes

Primary

MeasureTime frameDescription
Change in muscle protein synthesis from baseline to 16 weeksMeasured at week 0 (baseline) and week 16The 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

MeasureTime frameDescription
Change in insulin sensitivity from 0 (baseline) and 16 weeksMeasured at week 0 (baseline) and week 16The 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026