Association Between the Menstrual Cycle and Weight Loss

This study has been completed.
Sponsor:
Collaborator:
Sierra Neuropharmaceuticals
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01119976
First received: January 7, 2010
Last updated: December 6, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Overweight
Obesity
Behavioral: Reduced calorie diet and exercise plan
Behavioral: Different reduced calorie diet and exercise plan

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Evaluation of the Association Between the Menstrual Cycle and Weight Loss in Healthy, Overweight Premenopausal Women

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Body weight [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Waist Circumference [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: January 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Reduced calorie diet and exercise plan that changes with phases of the menstrual cycle
Behavioral: Reduced calorie diet and exercise plan
Participants will receive written diet and exercise instructions to follow for the duration of the study.
Active Comparator: Group B
Different reduced calorie diet and exercise plan based on MyPyramid.gov website
Behavioral: Different reduced calorie diet and exercise plan
Participants will receive written diet and exercise instructions to follow for the duration of the study.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01119976

Locations
United States, Colorado
Center for Human Nutrition
Denver, Colorado, United States, 80220
Sponsors and Collaborators
University of Colorado, Denver
Sierra Neuropharmaceuticals
Investigators
Principal Investigator: James O Hill, Ph.D. University of Colorado Denver and Health Sciences Center
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01119976     History of Changes
Other Study ID Numbers: 09-0983
Study First Received: January 7, 2010
Last Updated: December 6, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Overweight
Weight Loss
Body Weight
Body Weight Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014