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Association Between the Menstrual Cycle and Weight Loss

This study has been completed.
Sponsor:
Collaborator:
Sierra Neuropharmaceuticals
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01119976
First received: January 7, 2010
Last updated: December 6, 2012
Last verified: December 2012
History of Changes
  Purpose

This is a research study to look at the association between weight loss and the menstrual cycle in healthy, overweight, premenopausal women. Participants will be asked to follow a reduced-calorie diet and exercise plan for 3 months.


Condition Intervention
Overweight
Obesity
 Behavioral: Reduced calorie diet and exercise plan
Behavioral: Different reduced calorie diet and exercise plan

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Evaluation of the Association Between the Menstrual Cycle and Weight Loss in Healthy, Overweight Premenopausal Women

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Body weight [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Waist Circumference [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: January 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Reduced calorie diet and exercise plan that changes with phases of the menstrual cycle
 Behavioral: Reduced calorie diet and exercise plan
Participants will receive written diet and exercise instructions to follow for the duration of the study.
Active Comparator: Group B
Different reduced calorie diet and exercise plan based on MyPyramid.gov website
 Behavioral: Different reduced calorie diet and exercise plan
Participants will receive written diet and exercise instructions to follow for the duration of the study.

Detailed Description:

Two different reduced calorie diet and exercise plans will be compared. One plan changes diet and exercise prescription with the phases of the menstrual cycle, while the other is a standard reduced calorie diet and exercise plan based on MyPyramid.gov website.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy females between the ages of 18-40 (inclusive)
  • BMI between 26.5-35.4 kg/m² (inclusive)
  • Regular menstrual cycle (28 ± 3 days)
  • Weight stable (within ± 3-kg) 2 months prior to study inclusion
  • Must use barrier contraception (e.g. male/female condom) for the study's duration
  • Must be willing to follow the prescribed diet/exercise plan for the study's duration

Exclusion Criteria:

  • On hormonal contraceptives or any other daily use of medications which can make the subject unsuitable for inclusion in the study.
  • Any significant health problem (history of cancer, HIV/AIDS, Diabetes, cardiovascular disease, untreated hypothyroidism, etc.)
  • Restrictions against participating in cardiovascular exercise and strength training
  • Any condition, which in the opinion of the investigator makes the subject unsuitable for inclusion in the study.
  • Women who are pregnant, lactating, or planning to become pregnant during the study period
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01119976

Locations
United States, Colorado
Center for Human Nutrition
Denver, Colorado, United States, 80220
Sponsors and Collaborators
University of Colorado, Denver
Sierra Neuropharmaceuticals
Investigators
Principal Investigator: James O Hill, Ph.D. University of Colorado Denver and Health Sciences Center
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01119976     History of Changes
Other Study ID Numbers: 09-0983
Study First Received: January 7, 2010
Last Updated: December 6, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Obesity
Weight Loss
Overweight
Overnutrition
 Nutrition Disorders
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on June 18, 2013