NCT00777621

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P25-P50 for not_applicable diabetes

Timeline
Completed

Started Apr 2008

Longer than P75 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 22, 2008

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

February 12, 2016

Status Verified

February 1, 2016

Enrollment Period

6.9 years

First QC Date

October 21, 2008

Last Update Submit

February 11, 2016

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

  • Glucoregulatory function

    3-4 months

Study Arms (3)

Calorie restriction

ACTIVE COMPARATOR
Other: Calorie Restriction

Exercise

ACTIVE COMPARATOR
Other: Exercise

Calorie restriction and exercise

EXPERIMENTAL
Other: Calorie Restriction and Exercise

Interventions

Calorie RestrictionOTHER

This group will undergo a 20% reduction in energy intake without any change in energy expenditure.

Calorie restriction
ExerciseOTHER

This group will undergo a 20% increase in energy expenditure by exercising without any change in energy intake.

Exercise
Calorie Restriction and ExerciseOTHER

This group will undergo 10% reduction in energy intake and a 10% increase in energy expenditure via exercise.

Calorie restriction and exercise

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • females postmenopausal
  • no diabetes, cardiovascular disease, cancer
  • no orthopedic problems
  • not currently exercising
  • BMI between 25 and 29.9
  • nonsmokers

You may not qualify if:

  • current regular exercisers
  • premenopausal women
  • cardiovascular disease, lung disease, cancer, diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Louis University

St Louis, Missouri, 63104, United States

Location

Related Publications (3)

  • 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.

    PMID: 27580151DERIVED

  • 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.

    PMID: 27465384DERIVED

  • 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.

    PMID: 25877812DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Caloric RestrictionExercise

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsEnergy IntakeDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Edward P Weiss, PhD

    St. Louis University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 21, 2008

First Posted

October 22, 2008

Study Start

April 1, 2008

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

February 12, 2016

Record last verified: 2016-02

Locations

US(1)