Association Between the Menstrual Cycle and Weight Loss
Evaluation of the Association Between the Menstrual Cycle and Weight Loss in Healthy, Overweight Premenopausal Women
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2010
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 7, 2010
CompletedFirst Posted
Study publicly available on registry
May 10, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedDecember 7, 2012
December 1, 2012
7 months
January 7, 2010
December 6, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Body weight
3 months
Secondary Outcomes (1)
Waist Circumference
3 months
Study Arms (2)
Group A
EXPERIMENTALReduced calorie diet and exercise plan that changes with phases of the menstrual cycle
Group B
ACTIVE COMPARATORDifferent reduced calorie diet and exercise plan based on MyPyramid.gov website
Interventions
Participants will receive written diet and exercise instructions to follow for the duration of the study.
Participants will receive written diet and exercise instructions to follow for the duration of the study.
Eligibility Criteria
You may qualify if:
- Healthy females between the ages of 18-40 (inclusive)
- BMI between 26.5-35.4 kg/m² (inclusive)
- Regular menstrual cycle (28 ± 3 days)
- 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
You may not qualify if:
- Any significant health problem (history of cancer, HIV/AIDS, Diabetes, cardiovascular disease, untreated hypothyroidism, etc.)
- Restrictions against participating in cardiovascular exercise and strength training
- Women who are pregnant, lactating, or planning to become pregnant during the study period
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Colorado, Denverlead
- Sierra Neuropharmaceuticalscollaborator
Study Sites (1)
Center for Human Nutrition
Denver, Colorado, 80220, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James O Hill, Ph.D.
University of Colorado Denver and Health Sciences Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2010
First Posted
May 10, 2010
Study Start
January 1, 2010
Primary Completion
August 1, 2010
Study Completion
August 1, 2010
Last Updated
December 7, 2012
Record last verified: 2012-12