OverweightNCT01119976
Association Between the Menstrual Cycle and Weight Loss
A study testing Reduced calorie diet and exercise plan and Different reduced calorie diet and exercise plan in people with Overweight and Obesity, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Reduced calorie diet and exercise plan and Different reduced calorie diet and exercise plan
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Aug 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Association Between the Menstrual Cycle and Weight Loss in Healthy, Overweight Premenopausal Women
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.
Read the 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.
- Conditions
- Overweight, Obesity
- Being tested
- Reduced calorie diet and exercise plan, Different reduced calorie diet and exercise plan
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduced calorie diet and exercise planBehavioural
Participants will receive written diet and exercise instructions to follow for the duration of the study.
Different reduced calorie diet and exercise planBehavioural
Participants will receive written diet and exercise instructions to follow for the duration of the study.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Reduced calorie diet and exercise plan that changes with phases of the menstrual cycle Receives: Behavioral: Reduced calorie diet and exercise plan |
| Group B | Active comparator | Different reduced calorie diet and exercise plan based on MyPyramid.gov website Receives: Behavioral: Different reduced calorie diet and exercise plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Measured: 3 months
Secondary outcomes (1)
Waist Circumference
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2010 (estimated)
- Study startJan 2010
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Sierra Neuropharmaceuticals
- Responsible party
- Sponsor
- Investigators
- James O Hill, Ph.D., Principal investigator, University of Colorado Denver and Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01119976
- Sponsor's protocol ID
- 09-0983
- Status last verified
- Dec 2012
- First submitted
- 7 Jan 2010
- Last updated
- 7 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Association Between the Menstrual Cycle and Weight Loss in Healthy, Overweight Premenopausal Women
- ClinicalTrials.gov ID
- NCT01119976
- Acronym / sponsor ID
- 09-0983
- Conditions
- Overweight, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Sierra Neuropharmaceuticals
- Study start
- Jan 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 10 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Behavioral: Reduced calorie diet and exercise planReduced calorie diet and exercise plan that changes with phases of the menstrual cycle |
| Group B | Active comparator | Behavioral: Different reduced calorie diet and exercise planDifferent reduced calorie diet and exercise plan based on MyPyramid.gov website |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reduced calorie diet and exercise planParticipants will receive written diet and exercise instructions to follow for the duration of the study. | Behavioural | Group A |
| Different reduced calorie diet and exercise planParticipants will receive written diet and exercise instructions to follow for the duration of the study. | Behavioural | Group B |
Primary outcome
Body weight
Time frame: 3 months
1 secondary outcome
Waist Circumference
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James O Hill, Ph.D. principal investigator
University of Colorado Denver and Health Sciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reduced calorie diet and exercise plan and Different reduced calorie diet and exercise plan in people with Overweight and Obesity, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2012; AzTrials last refreshed its copy on 26 Oct 2026.