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

History of Changes

Tracking Information

First Received Date ^ICMJE

January 7, 2010

Last Updated Date

December 6, 2012

Start Date ^ICMJE

January 2010

Primary Completion Date

August 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Body weight [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01119976 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Waist Circumference [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Association Between the Menstrual Cycle and Weight Loss

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Condition ^ICMJE

Overweight
Obesity

Intervention ^ICMJE

Behavioral: Reduced calorie diet and exercise plan
Participants will receive written diet and exercise instructions to follow for the duration of the study.
Behavioral: Different reduced calorie diet and exercise plan
Participants will receive written diet and exercise instructions to follow for the duration of the study.

Study Arm (s)

Experimental: Group A
Reduced calorie diet and exercise plan that changes with phases of the menstrual cycle

Intervention: Behavioral: Reduced calorie diet and exercise plan
Active Comparator: Group B
Different reduced calorie diet and exercise plan based on MyPyramid.gov website

Intervention: Behavioral: Different reduced calorie diet and exercise plan

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2010

Primary Completion Date

August 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 40 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01119976

Other Study ID Numbers ^ICMJE

09-0983

Has Data Monitoring Committee

Responsible Party

University of Colorado, Denver

Study Sponsor ^ICMJE

University of Colorado, Denver

Collaborators ^ICMJE

Sierra Neuropharmaceuticals

Investigators ^ICMJE

Principal Investigator:

James O Hill, Ph.D.

University of Colorado Denver and Health Sciences Center

Information Provided By

University of Colorado, Denver

Verification Date

December 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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