Association Between the Menstrual Cycle and Weight Loss

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01119976
• Other study ID #: 09-0983
• Status: Completed
• Phase: N/A
• First received: January 7, 2010
• Last updated: December 6, 2012
• Start date: January 2010
• Est. completion date: August 2010

Study information

• Verified date: December 2012
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Behavioral:
• Reduced calorie diet and exercise plan
Participants will receive written diet and exercise instructions to follow for the duration of the study.
• Different reduced calorie diet and exercise plan
Participants will receive written diet and exercise instructions to follow for the duration of the study.

Locations

Country	Name	City	State
United States	Center for Human Nutrition	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Sierra Neuropharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight		3 months	No
Secondary	Waist Circumference		3 months	No