Caloric Restriction, Exercise, and Glucoregulation in Humans (CREG)
February 11, 2016 updated by: Edward Weiss, Ph.D., St. Louis University
Weight loss induced by caloric restriction alone (CR) and by exercise alone (EX) result in similar effects on blood glucose and insulin.
The purpose of this study is to assess the hypothesis that weight loss through caloric restriction plus exercise will result in greater improvements on glucose tolerance and insulin action than similar weight losses through CR or EX alone.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Participants are randomized into caloric restriction, exercise, and caloric restriction plus exercise weight loss groups.
Measurements of blood glucose and insulin, oral glucose tolerance, and matched glucose infusion will be done at baseline and after weight loss of 6% of body weight.
Other tests include maximal oxygen uptake (VO2max), strength tests, blood pressure, blood lipids, serum inflammatory markers, dual X-ray absorptiometry (DEXA) for bone density and body composition, physical activity levels, dietary intakes, and measures of arterial stiffness.
Study Type
Interventional
Enrollment (Actual)
69
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Missouri
-
Saint Louis, Missouri, United States, 63104
- Saint Louis University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- females postmenopausal
- no diabetes, cardiovascular disease, cancer
- no orthopedic problems
- not currently exercising
- BMI between 25 and 29.9
- nonsmokers
Exclusion Criteria:
- current regular exercisers
- premenopausal women
- cardiovascular disease, lung disease, cancer, diabetes
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Exercise
|
This group will undergo a 20% increase in energy expenditure by exercising without any change in energy intake.
|
|
Active Comparator: Calorie restriction
|
This group will undergo a 20% reduction in energy intake without any change in energy expenditure.
|
|
Experimental: Calorie restriction and exercise
|
This group will undergo 10% reduction in energy intake and a 10% increase in energy expenditure via exercise.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Glucoregulatory function
Time Frame: 3-4 months
|
3-4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Edward P Weiss, PhD, St. Louis University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Weiss EP, Jordan RC, Frese EM, Albert SG, Villareal DT. Effects of Weight Loss on Lean Mass, Strength, Bone, and Aerobic Capacity. Med Sci Sports Exerc. 2017 Jan;49(1):206-217. doi: 10.1249/MSS.0000000000001074.
- Weiss EP, Albert SG, Reeds DN, Kress KS, McDaniel JL, Klein S, Villareal DT. Effects of matched weight loss from calorie restriction, exercise, or both on cardiovascular disease risk factors: a randomized intervention trial. Am J Clin Nutr. 2016 Sep;104(3):576-86. doi: 10.3945/ajcn.116.131391. Epub 2016 Jul 27.
- Weiss EP, Albert SG, Reeds DN, Kress KS, Ezekiel UR, McDaniel JL, Patterson BW, Klein S, Villareal DT. Calorie Restriction and Matched Weight Loss From Exercise: Independent and Additive Effects on Glucoregulation and the Incretin System in Overweight Women and Men. Diabetes Care. 2015 Jul;38(7):1253-62. doi: 10.2337/dc14-2913. Epub 2015 Apr 15.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2008
Primary Completion (Actual)
March 1, 2015
Study Completion (Actual)
March 1, 2015
Study Registration Dates
First Submitted
October 21, 2008
First Submitted That Met QC Criteria
October 21, 2008
First Posted (Estimate)
October 22, 2008
Study Record Updates
Last Update Posted (Estimate)
February 12, 2016
Last Update Submitted That Met QC Criteria
February 11, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- K01DK080886 (U.S. NIH Grant/Contract)
- 1K01DK080886-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.