Association Between the Menstrual Cycle and Weight Loss
NCT ID: NCT01119976
Last Updated: 2012-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2010-01-31
2010-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group A
Reduced calorie diet and exercise plan that changes with phases of the menstrual cycle
Reduced calorie diet and exercise plan
Participants will receive written diet and exercise instructions to follow for the duration of the study.
Group B
Different reduced calorie diet and exercise plan based on MyPyramid.gov website
Different reduced calorie diet and exercise plan
Participants will receive written diet and exercise instructions to follow for the duration of the study.
Interventions
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Reduced calorie diet and exercise plan
Participants will receive written diet and exercise instructions to follow for the duration of the study.
Different reduced calorie diet and exercise plan
Participants will receive written diet and exercise instructions to follow for the duration of the study.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
40 Years
FEMALE
Yes
Sponsors
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Sierra Neuropharmaceuticals
UNKNOWN
University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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James O Hill, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Colorado Denver and Health Sciences Center
Locations
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Center for Human Nutrition
Denver, Colorado, United States
Countries
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Other Identifiers
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09-0983
Identifier Type: -
Identifier Source: org_study_id