Obesity & OverweightLFDNCT07227766
Dietary Reversal of the Reprometabolic Syndrome
A study testing Low-fat diet in people with Obesity & Overweight and Infertility, Female, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study proposes to test the specific question that a eucaloric, low-fat diet given to women with obesity will result in an increase in reproductive hormones. 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
- Obesity & Overweight, Infertility, Female
- What is being tested?
- Low-fat diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2024to 30 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Normal TSH and prolactin
- Regular menstrual cycles every 25-40 days
- No history of chronic disease affecting hormone production, metabolism or clearance
- No use of reproductive hormones, or medications/supplements known to impact them, within 3 months of enrollment
- Use of a reliable method of contraception (female or male partner sterilization, IUD, abstinence, diaphragm or cervical cap)
- Normal ovarian reserve (AMH of 0.5ng/ml or greater)
- Normal testosterone levels at screening or absence of clinical evidence of hyperandrogenemia (acne, facial hirsutism [defined as Ferriman-Gallwey score>8] or alopecia)
Who cannot join
- Baseline dietary assessment indicative of 28% or less daily calories from fat
- Inability to comply with the protocol (many meals per week eaten outside of the home, frequent travel)
- Pregnancy or planned pregnancy within next 6 months at time of screening
- HbA1C >6.5%
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado School of Medicine
Aurora, Colorado, 80045
About this study
This study proposes to test the specific question that a eucaloric, low-fat diet given to women with obesity will result in an increase in reproductive hormones.
Read the detailed description
This an open-label, multi site study in pre-menopausal women aged 18-40 years old with a history of regular menstrual cycles (25-35 days long) of high BMI. The objective of the study will be to determine the effects of a one month long, eucaloric low-fat diet on reproductive hormone levels in women with a high BMI. The study will occur over 4 menstrual cycle (approximately 4 months). During the study the participants will have a pre-diet cycle where no food will be consumed, an on-diet cycle where the customized low-fat diet will be consumed, and two post diet cycles. First morning voided urine will be collected during all four cycles along with 3 blood draws during the study. Participants will be asked to use a reliable barrier method of birth control or abstain from intercourse during the study.
- Conditions
- Obesity & Overweight, Infertility, Female
- Being tested
- Low-fat diet
- Keywords
- Infertility, Reproductive Hormones, Low-Fat Diet, Obesity, Hypothalamic-pitutary-ovarian axis
- Medical subject headings
- Obesity, Overweight, Infertility, Female, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-fat dietDietary supplement
Participants will eat a one-month eucaloric high-fat diet.
| Study group | Role | What they receive |
|---|---|---|
| Low-Fat Diet | Experimental | Participants will eat a customized, eucaloric low-fat diet for one month Receives: Dietary Supplement: Low-fat diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary Pregnadiol Glucouronide concentration in ug/mg creatinine
Measured: From enrollment for 4 months post enrollment
Secondary outcomes (1)
Amount of Urinary estrogen
Urinary estrogen concentration in microgram/mg of Creatinine
Measured: From enrollment to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2025
- Study start10 Aug 2024
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nanette Santoro, MD, Principal investigator, University of Colorado School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07227766
- Sponsor's protocol ID
- 23-1702
- Acronym
- LFD
- Status last verified
- Nov 2025
- First submitted
- 11 Nov 2025
- Last updated
- 14 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Reversal of the Reprometabolic Syndrome
- ClinicalTrials.gov ID
- NCT07227766
- Acronym / sponsor ID
- LFD / 23-1702
- Conditions
- Obesity & Overweight, Infertility, Female
- Keywords
- Infertility, Reproductive Hormones, Low-Fat Diet, Obesity, Hypothalamic-pitutary-ovarian axis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 10 Aug 2024 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 13 Nov 2025 (actual)
- 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 study proposes to test the specific question that a eucaloric, low-fat diet given to women with obesity will result in an increase in reproductive hormones.
Detailed description
This an open-label, multi site study in pre-menopausal women aged 18-40 years old with a history of regular menstrual cycles (25-35 days long) of high BMI. The objective of the study will be to determine the effects of a one month long, eucaloric low-fat diet on reproductive hormone levels in women with a high BMI. The study will occur over 4 menstrual cycle (approximately 4 months). During the study the participants will have a pre-diet cycle where no food will be consumed, an on-diet cycle where the customized low-fat diet will be consumed, and two post diet cycles. First morning voided urine will be collected during all four cycles along with 3 blood draws during the study. Participants will be asked to use a reliable barrier method of birth control or abstain from intercourse during the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low-Fat Diet | Experimental | Dietary Supplement: Low-fat dietParticipants will eat a customized, eucaloric low-fat diet for one month |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Normal TSH and prolactin
- Regular menstrual cycles every 25-40 days
- No history of chronic disease affecting hormone production, metabolism or clearance
- No use of reproductive hormones, or medications/supplements known to impact them, within 3 months of enrollment
- Use of a reliable method of contraception (female or male partner sterilization, IUD, abstinence, diaphragm or cervical cap)
Key exclusion criteria (4 listed)
- Baseline dietary assessment indicative of 28% or less daily calories from fat
- Inability to comply with the protocol (many meals per week eaten outside of the home, frequent travel)
- Pregnancy or planned pregnancy within next 6 months at time of screening
- HbA1C >6.5%
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 |
|---|---|---|
| Low-fat dietParticipants will eat a one-month eucaloric high-fat diet. | Dietary supplement | Low-Fat Diet |
Primary outcome
Urinary Pregnadiol Glucouronide concentration in ug/mg creatinine
Time frame: From enrollment for 4 months post enrollment
1 secondary outcome
Amount of Urinary estrogen
Time frame: From enrollment to 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2025.
- Individual participant dataSharing planned: Undecided
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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.
Nanette Santoro, MD principal investigator
University of Colorado School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-fat diet in people with Obesity & Overweight and Infertility, Female, 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 7 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 14 Nov 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Urinary Pregnadiol Glucouronide concentration in ug/mg creatinine (time frame: From enrollment for 4 months post enrollment). 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 14 Nov 2025.