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NCT Number: NCT01119976

Association Between the Menstrual Cycle and Weight Loss

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.

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Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Center for Human Nutrition

Denver, Colorado, 80220, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Reduced calorie diet and exercise plan

Behavioral

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

Different reduced calorie diet and exercise plan

Behavioral

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

Primary outcomes

  1. Body weight

    Time frame: 3 months

Secondary outcomes

  1. Waist Circumference

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Sierra Neuropharmaceuticals

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
May 10, 2010
Registry last updated
Dec 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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