Association Between the Menstrual Cycle and Weight Loss

N/ACompletedNCT01119976

University of Colorado, Denver20 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Overweight Obesity

Interventions

Reduced calorie diet and exercise planBEHAVIORAL

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

Different reduced calorie diet and exercise planBEHAVIORAL

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Center for Human Nutrition

Denver, Colorado, United States

Outcomes

Primary Outcomes

Body weight

Time frame: 3 months

Secondary Outcomes

Waist Circumference

Time frame: 3 months

Data from ClinicalTrials.gov

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