Association Between the Menstrual Cycle and Weight Loss

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Overweight; Obesity

Treatments: Behavioral: Different reduced calorie diet and exercise plan; Behavioral: Reduced calorie diet and exercise plan

Study type: Interventional

Funder types: Other

Identifiers

NCT01119976

09-0983

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Group A

Experimental group

Description:

Reduced calorie diet and exercise plan that changes with phases of the menstrual cycle

Treatment:

Behavioral: Reduced calorie diet and exercise plan

Group B

Active Comparator group

Description:

Different reduced calorie diet and exercise plan based on MyPyramid.gov website

Treatment:

Behavioral: Different reduced calorie diet and exercise plan