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Association Between the Menstrual Cycle and Weight Loss

Sponsor
University of Colorado, Denver (Other)
Overall Status
Completed
CT.gov ID
NCT01119976
Collaborator
Sierra Neuropharmaceuticals (Other)
20
Enrollment
1
Location
2
Arms
7
Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Behavioral: Reduced calorie diet and exercise plan
  • Behavioral: Different reduced calorie diet and exercise plan
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Evaluation of the Association Between the Menstrual Cycle and Weight Loss in Healthy, Overweight Premenopausal Women
Study Start Date :
Jan 1, 2010
Actual Primary Completion Date :
Aug 1, 2010
Actual Study Completion Date :
Aug 1, 2010

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Body weight [3 months]

Secondary Outcome Measures

  1. Waist Circumference [3 months]

Eligibility Criteria

Criteria

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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01119976
Other Study ID Numbers:
  • 09-0983
First Posted:
May 10, 2010
Last Update Posted:
Dec 7, 2012
Last Verified:
Dec 1, 2012
Additional relevant MeSH terms:
Overweight
Weight Loss

Study Results

No Results Posted as of Dec 7, 2012