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Caloric Restriction, Exercise, and Glucoregulation in Humans (CREG)

This study has been completed.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Edward Weiss, Ph.D., St. Louis University Identifier:
First received: October 21, 2008
Last updated: February 11, 2016
Last verified: February 2016
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.

Condition Intervention
Other: Calorie Restriction
Other: Exercise
Other: Calorie Restriction and Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Caloric Restriction, Exercise, and Glucoregulation in Humans

Resource links provided by NLM:

Further study details as provided by St. Louis University:

Primary Outcome Measures:
  • Glucoregulatory function [ Time Frame: 3-4 months ]

Enrollment: 69
Study Start Date: April 2008
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Calorie restriction Other: Calorie Restriction
This group will undergo a 20% reduction in energy intake without any change in energy expenditure.
Active Comparator: Exercise Other: Exercise
This group will undergo a 20% increase in energy expenditure by exercising without any change in energy intake.
Experimental: Calorie restriction and exercise Other: Calorie Restriction and Exercise
This group will undergo 10% reduction in energy intake and a 10% increase in energy expenditure via exercise.

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.

Ages Eligible for Study:   45 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00777621

United States, Missouri
Saint Louis University
Saint Louis, Missouri, United States, 63104
Sponsors and Collaborators
St. Louis University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Edward P Weiss, PhD St. Louis University