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Low-Fat diet may boost fertility in obese women

NCT ID NCT07227766

Symptom relief Sponsor: University of Colorado, Denver Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether a low-fat diet can increase reproductive hormones in women with obesity. Thirty women with regular cycles and no other hormone issues will follow a carefully controlled diet. The goal is to see if diet alone can improve hormone levels linked to fertility.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 40 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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) Exclusion Criteria: * 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%

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Conditions

The condition(s) this trial relates to.

female infertility infertility disorder Obesity obesity disorder Overweight

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Infertility, female Obesity / overweight

Contacts and locations

Locations

  • University of Colorado School of Medicine

    Aurora, Colorado, 80045, United States

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