Association Between the Menstrual Cycle and Weight Loss

Not Applicable

Completed

• Conditions: Overweight; Obesity
• Interventions: Behavioral: Reduced calorie diet and exercise plan; Behavioral: Different reduced calorie diet and exercise plan

• Registration Number: NCT01119976
• Lead Sponsor: University of Colorado, Denver

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.

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 Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-07
• Study First Submitted QC: 2010-05-06
• Study First Posted: 2010-05-10
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-06
• Last Update Posted: 2012-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Reduced calorie diet and exercise plan	Reduced calorie diet and exercise plan that changes with phases of the menstrual cycle
Group B	Different reduced calorie diet and exercise plan	Different reduced calorie diet and exercise plan based on MyPyramid.gov website

Primary Outcome Measures

Name	Time	Method
Body weight	3 months

Secondary Outcome Measures

Name	Time	Method
Waist Circumference	3 months

Trial Locations

Locations (1)

Center for Human Nutrition; 🇺🇸 Denver, Colorado, United States