Effects of Calorie Restriction on Accumulation of Old, Modified Proteins in Abdominally Obese Adults
NCT ID: NCT01497106
Last Updated: 2014-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
29 participants
INTERVENTIONAL
2011-12-31
2014-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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
Participants will continue their normal living for entire time of the study, totaling 16 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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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)
45 Years
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Mayo Clinic
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
K. Sreekumaran Nair
Professor of Medicine
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
K. Sreekumaran Nair, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mayo Clinic
Rochester, Minnesota, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
11-006181
Identifier Type: -
Identifier Source: org_study_id