Back to resultsAssociation Between the Menstrual Cycle and Weight Loss
Primary Purpose
Overweight, Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Reduced calorie diet and exercise plan
Different reduced calorie diet and exercise plan
Sponsored by
About this trial
This is an interventional treatment trial for Overweight
Eligibility 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
Sites / Locations
- Center for Human Nutrition
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group A
Group B
Arm Description
Reduced calorie diet and exercise plan that changes with phases of the menstrual cycle
Different reduced calorie diet and exercise plan based on MyPyramid.gov website
Outcomes
Primary Outcome Measures
Body weight
Secondary Outcome Measures
Waist Circumference
Full Information
NCT ID
NCT01119976
First Posted
January 7, 2010
Last Updated
December 6, 2012
Sponsor
University of Colorado, Denver
Collaborators
Sierra Neuropharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01119976
Brief Title
Association Between the Menstrual Cycle and Weight Loss
Official Title
Evaluation of the Association Between the Menstrual Cycle and Weight Loss in Healthy, Overweight Premenopausal Women
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Sierra Neuropharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Reduced calorie diet and exercise plan that changes with phases of the menstrual cycle
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Different reduced calorie diet and exercise plan based on MyPyramid.gov website
Intervention Type
Behavioral
Intervention Name(s)
Reduced calorie diet and exercise plan
Intervention Description
Participants will receive written diet and exercise instructions to follow for the duration of the study.
Intervention Type
Behavioral
Intervention Name(s)
Different reduced calorie diet and exercise plan
Intervention Description
Participants will receive written diet and exercise instructions to follow for the duration of the study.
Primary Outcome Measure Information:
Title
Body weight
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Waist Circumference
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James O Hill, Ph.D.
Organizational Affiliation
University of Colorado Denver and Health Sciences Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Human Nutrition
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
12. IPD Sharing Statement
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Association Between the Menstrual Cycle and Weight Loss
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