Association Between the Menstrual Cycle and Weight Loss

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01119976

Enrollment

Registered

2010-05-10

Start date

2010-01-31

Completion date

2010-08-31

Last updated

2012-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Overweight

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.

Interventions

BEHAVIORALReduced calorie diet and exercise plan

Participants will receive written diet and exercise instructions to follow for the duration of the study.

BEHAVIORALDifferent reduced calorie diet and exercise plan

Participants will receive written diet and exercise instructions to follow for the duration of the study.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

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

Design outcomes

Primary

Measure	Time frame
Body weight	3 months

Secondary

Measure	Time frame
Waist Circumference	3 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026