Polycystic Ovary SyndromeNCT06031753
Effects of Intermittent Fasting on Polycystic Ovary Syndrome (PCOS) Compared to Standard Treatment
A study testing Time restricted eating in people with Polycystic Ovary Syndrome and Insulin Resistance, run by Instituto Superior de Investigación en Estética Médica, Nutrición y Anti-Envejecimiento at 1 site in Mexico.
Trial summary
The purpose of this study is to assess the effects of Time restricted eating in patients diagnosed with polycystic ovary syndrome, comparing it to the standard hormonal treatment. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome, Insulin Resistance
- What is being tested?
- Time restricted eating
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteMexico
- Study dates
- 3 Jun 2021to 11 Oct 2022
- 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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age: 20 - 35 years
- Mild to moderate exercise at least 4 times per week
- Body Mass Index (BMI) of 20-24.9
- Diagnosis of PCOS by Rotterdam criteria
- Type of oral contraceptives: combined (estrogens and progestins) in group 1 and 2.
- PCOS Phenotype A, B, C
- nulliparity
- Signed informed consent letter
Who cannot join
- Menopause or perimenopause
- Night work shifts
- Phenotype D (without hyperandrogenism)
- Associated pathologies such as diabetes mellitus, arterial hypertension, metabolic syndrome, neoplasms, autoimmune diseases.
- Intake of medications on a regular basis, not including oral contraceptives for group 1 and 2.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Time-restricted Eating as a Novel Approach to PCOS Remission, Compared to Guideline's Standard Hormonal Treatment.
The purpose of this study is to assess the effects of Time restricted eating in patients diagnosed with polycystic ovary syndrome, comparing it to the standard hormonal treatment.
Read the detailed description
After being informed about the study and potential risks, all patients were given a written informed consent. Patients were recruited through social media and digital questionnaires, to make sure they met the criteria. There was a semi aleatory distribution of the patients into three different groups, one group underwent time restricted eating with no hormonal treatment (TRE group), the second group received hormonal treatment combined with time restricted eating (combined group) and the last group received only hormonal treatment (HT). PCOS was diagnosed using Rotterdam criteria, which were evaluated according to the ultrasound, blood samples and self reported menstrual cycle.
Blood samples and transvaginal ultrasound were taken at day 0 and 90 to evaluate hormonal status, including insulin and glucose.
Homeostatic assessment for insulin resistance (HOMA-IR) was calculated to determine insulin resistance, as well as metabolic disfunction.
After data collection, statistical analyses was done to determine the effect of the different approaches.
- Conditions
- Polycystic Ovary Syndrome, Insulin Resistance
- Being tested
- Time restricted eating
- Medical subject headings
- Polycystic Ovary Syndrome, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time restricted eatingBehavioural
Also called time restricted eating with hormonal treatment
Only eating windows were determined to an 6 hour period, starting at 12:00hrs and ending at 18:00hrs. After that, patients in group 1 and 2 were indicated not to consume any calories. The composition of their diet was not modified, it was assessed by performing a 24-hour recall to make sure there were no significant changes in diet composition throughout the study.
| Study group | Role | What they receive |
|---|---|---|
| TRE | Experimental | Only time restricted eating was carried on by this arm, having the first meal of the day at 12:00hrs and last meal of the day at 18:00hrs. No other medication was allowed during the study for this group. Receives: Behavioral: Time restricted eating |
| TRE-HT | Experimental | They carried on Time Restricted eating, in combination with the oral contraceptives used for the standard hormonal treatment. First meal of the day at 12:00hrs and last meal of the day at 18:00hrs. Other than oral contraceptives, no medication was allowed during the 3 months of the study. Receives: Behavioral: Time restricted eating |
| HT | No intervention | No time restricted eating was practiced by this group, only oral contraceptives were taken, serving as the control group by having the standard hormonal treatment. No modification to their daily habits and routine was made. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCOS Rotterdam criteria
Ovary volume >9ml, presence of 12 or more follicles, biochemical or clinical signs of hyperandrogenism and anovulation.
Measured: 3 months
Secondary outcomes (1)
Insulin resistance (IR)
HOMA-IR was calculated with insulin and glucose fasting levels to determine the severity of insulin resistance
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 posted11 Sep 2023
- Study start3 Jun 2021
- Primary completion27 Nov 2021
- Study completion11 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- group 1: time restricted eating with NO hormonal treatment group 2: time restricted eating with hormonal treatment group 3: hormonal treatment with NO time restricted eating
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Superior de Investigación en Estética Médica, Nutrición y Anti-Envejecimiento
- Sponsor type
- University, hospital or other
- Collaborators
- Centro Medico ABC
- Responsible party
- Principal investigator, Isabela von Damm Longoria, Instituto Superior de Investigación en Estética Médica, Nutrición y Anti-Envejecimiento
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06031753
- Sponsor's protocol ID
- AYUSOP22
- Status last verified
- Sep 2023
- First submitted
- 4 Sep 2023
- Last updated
- 11 Sep 2023
- Results posted
- 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 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time-restricted Eating as a Novel Approach to PCOS Remission, Compared to Guideline's Standard Hormonal Treatment.
- ClinicalTrials.gov ID
- NCT06031753
- Acronym / sponsor ID
- AYUSOP22
- Conditions
- Polycystic Ovary Syndrome, Insulin Resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Instituto Superior de Investigación en Estética Médica, Nutrición y Anti-EnvejecimientoUniversity, hospital or other
- Collaborators
- Centro Medico ABC
- Study start
- 3 Jun 2021 (actual)
- Primary completion
- 27 Nov 2021 (actual)
- Study completion
- 11 Oct 2022 (actual)
- First posted
- 11 Sep 2023 (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.
The purpose of this study is to assess the effects of Time restricted eating in patients diagnosed with polycystic ovary syndrome, comparing it to the standard hormonal treatment.
Detailed description
After being informed about the study and potential risks, all patients were given a written informed consent. Patients were recruited through social media and digital questionnaires, to make sure they met the criteria. There was a semi aleatory distribution of the patients into three different groups, one group underwent time restricted eating with no hormonal treatment (TRE group), the second group received hormonal treatment combined with time restricted eating (combined group) and the last group received only hormonal treatment (HT). PCOS was diagnosed using Rotterdam criteria, which were evaluated according to the ultrasound, blood samples and self reported menstrual cycle.
Blood samples and transvaginal ultrasound were taken at day 0 and 90 to evaluate hormonal status, including insulin and glucose.
Homeostatic assessment for insulin resistance (HOMA-IR) was calculated to determine insulin resistance, as well as metabolic disfunction.
After data collection, statistical analyses was done to determine the effect of the different approaches.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- group 1: time restricted eating with NO hormonal treatment group 2: time restricted eating with hormonal treatment group 3: hormonal treatment with NO time restricted eating
| Arm | Type | Receives |
|---|---|---|
| TRE | Experimental | Behavioral: Time restricted eatingOnly time restricted eating was carried on by this arm, having the first meal of the day at 12:00hrs and last meal of the day at 18:00hrs. No other medication was allowed during the study for this group. |
| TRE-HT | Experimental | Behavioral: Time restricted eatingThey carried on Time Restricted eating, in combination with the oral contraceptives used for the standard hormonal treatment. First meal of the day at 12:00hrs and last meal of the day at 18:00hrs. Other than oral contraceptives, no medication was allowed during the 3 months of the study. |
| HT | No intervention | –No time restricted eating was practiced by this group, only oral contraceptives were taken, serving as the control group by having the standard hormonal treatment. No modification to their daily habits and routine was made. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age: 20 - 35 years
- Mild to moderate exercise at least 4 times per week
- Body Mass Index (BMI) of 20-24.9
- Diagnosis of PCOS by Rotterdam criteria
- Type of oral contraceptives: combined (estrogens and progestins) in group 1 and 2.
Key exclusion criteria (5 listed)
- Menopause or perimenopause
- Night work shifts
- Phenotype D (without hyperandrogenism)
- Associated pathologies such as diabetes mellitus, arterial hypertension, metabolic syndrome, neoplasms, autoimmune diseases.
- Intake of medications on a regular basis, not including oral contraceptives for group 1 and 2.
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 |
|---|---|---|
| Time restricted eatingAlso: time restricted eating with hormonal treatmentOnly eating windows were determined to an 6 hour period, starting at 12:00hrs and ending at 18:00hrs. After that, patients in group 1 and 2 were indicated not to consume any calories. The composition of their diet was not modified, it was assessed by performing a 24-hour recall to make sure there were no significant changes in diet composition throughout the study. | Behavioural | TRE, TRE-HT |
Primary outcome
PCOS Rotterdam criteria
Time frame: 3 months
Ovary volume >9ml, presence of 12 or more follicles, biochemical or clinical signs of hyperandrogenism and anovulation.
1 secondary outcome
Insulin resistance (IR)
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 11 Sep 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time restricted eating in people with Polycystic Ovary Syndrome and Insulin Resistance, run by Instituto Superior de Investigación en Estética Médica, Nutrición y Anti-Envejecimiento at 1 site in Mexico.
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 8 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 11 Sep 2023. 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 Mexico. 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?
PCOS Rotterdam criteria (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 11 Sep 2023.