Association Between the Menstrual Cycle and Weight Loss

December 6, 2012 updated by: University of Colorado, Denver

Evaluation of the Association Between the Menstrual Cycle and Weight Loss in Healthy, Overweight Premenopausal Women

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

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

  • United States
    • Colorado
      • Denver, Colorado, United States, 80220
        • Center for Human Nutrition

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

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Body weight
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Waist Circumference
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

Sierra Neuropharmaceuticals

Investigators

  • Principal Investigator: James O Hill, Ph.D., University of Colorado Denver and Health Sciences Center

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

January 1, 2010

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

January 7, 2010

First Submitted That Met QC Criteria

May 6, 2010

First Posted (Estimate)

May 10, 2010

Study Record Updates

Last Update Posted (Estimate)

December 7, 2012

Last Update Submitted That Met QC Criteria

December 6, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-0983

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.

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