PCOSTimeMAPNCT05126199
Time-restricted Eating to Improve Metabolic Abnormalities in Polycystic Ovarian Syndrome
A study testing Time restricted eating and Normal ad libitum diet in people with PCOS and Hyperinsulinemia, run by Ruairí Floyd at 1 site in Ireland.
Trial summary
Polycystic ovarian syndrome (PCOS) is associated with metabolic symptoms such as hyperinsulinemia. Time-restricted eating may reduce serum insulin and improve insulin resistance in patients with PCOS. Currently, there are few studies investigating time-restricted eating in patients with PCOS. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- PCOS, Hyperinsulinemia, Insulin Resistance
- What is being tested?
- Time restricted eating and Normal ad libitum diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIreland
- Study dates
- 5 May 2021to 31 Jan 2023
- 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 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult women of reproductive age with confirmed diagnosis of PCOS (Rotterdam Criteria, including at least 2 of 3 characteristics: oligomenorrhea, clinical and/or biochemical hyperandrogenism and ultrasound criteria)
- No BMI restriction
- Able and willing to provide explicit, informed consent
Who cannot join
- Type 1 diabetes, medication-controlled type 2 diabetes
- Pregnancy
- Currently participating in weight loss programme, or reported weight change in last 3 months (>5% of current body weight)
- Documented history of eating disorder
- Ovulation medication, such as clomiphene citrate
- Weight loss medication affecting weight or appetite in last 6 months, including weight loss medications, antipsychotic drugs or other medications as determine by the physician (eg. Semaglutide, liraglutide, orlistat, amphetamines, Qsymia (phentermine-topiramate), bupropion-naltrexone (Contrave))
Show all 9Show fewer
- Known liver, renal or thyroid dysfunction (not including non-alcoholic fatty liver disease with hypothyroidism on treatment or subclinical hypothyroidism seen in a large proportion of patients with PCOS)
- Unable to participate in follow-up for at least 24 weeks
- Unable or unwilling to provide explicit, informed consent
Trial locations and contacts
1 site in 1 country.
Ireland1 site, 1 recruiting
- Recruiting
Robert Graves Institute of Endocrinology, Tallaght University Hospital
Dublin, Leinster, D24 NR0A
Ruairí Floyd, BSc BMBS, floydr@tcd.ie
About this study
Official title: The Effect of Time-restricted Eating on Insulin Levels and Other Metabolic Abnormalities in Polycystic Ovarian Syndrome: A Randomised Feasibility Study of Real-world Clinical Advice
Polycystic ovarian syndrome (PCOS) is associated with metabolic symptoms such as hyperinsulinemia. Time-restricted eating may reduce serum insulin and improve insulin resistance in patients with PCOS. Currently, there are few studies investigating time-restricted eating in patients with PCOS. The investigators plan to test the feasibility of time-restricted eating in the management of PCOS by means of a real-world clinical intervention. The investigators will determine if an 18:6 eating protocol reduces insulin levels by means of a randomised controlled crossover trial.
Read the detailed description
Background: Polycystic ovarian syndrome (PCOS) is the most common reproductive endocrinopathy in women of reproductive age with many associated metabolic symptoms, in particular hyperinsulinemia, insulin resistance and a high lifetime risk of type 2 diabetes mellitus. The effects of time-restricted eating on metabolic profiles have been investigated in many endocrinopathies, but there are minimal data in PCOS.
Methods: This study will investigate the feasibility of time-restricted eating in the management of PCOS, and its effects on insulin levels and other metabolic parameters.
To achieve this, the investigators will recruit 20 patients with PCOS (normal weight, overweight, obese).
In a randomised cross-over design, participants will be observed for two consecutive 12 week periods (with a 4 weeks washout period in between) following either 'time-restricted eating' or 'usual eating', detailed below.
- 18:6 protocol: 18 hours of fasting and a 6-hours eating window, with no other specific dietary advice. Participants choose their own 6-hour period according to their lifestyle and preference.
- Usual eating: follow usual eating patterns, no time restriction, no other dietary advice
When fasting, participants are permitted to consume plain water, unflavoured/unsweetened sparkling water, black breakfast tea and black coffee.
Dietary intake will be determined at baseline, at midpoint of each study arm, and at the end of the study using Nutritics software. Participants will self-record dietary intake using the Nutritics 'app'.
The primary endpoints will be serum insulin and feasibility of the intervention as well as safety, acceptability, and compliance with time-restricted eating.
Secondary endpoints will be insulin resistance (Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)), androgens (testosterone, free testosterone, dehydroepiandrosterone sulfate (DHEA-S), androstenedione, 17-Hydroxyprogesterone (17-OHP) and sex hormone binding globulin (SHBG)), appetite (10-point visual analogue scale), hunger/satiety (glucagon-like peptide 1 (GLP-1), grehlin, PYY and oxyntomodulin, fasting glucose, HbA1c, lipid profile, lipoprotein lipid A, apolipoprotein A1, apolipoprotein B, anthropometrics (weight, body mass index, hip and waist circumference), dietary intake (calorie and macronutrient intake; micronutrient intake including iron, calcium; dietary pattern including timing).
Results: Safety and acceptability will be measured by adverse event reporting and measurement of adherence. Paired t-test will be used to assess between baseline and post intervention measurements. Results considered statistically significant if p<0.05.
Discussion: Time-restricted eating has potential to aid in improvement of insulin resistance in patients with PCOS based on studies in other populations. There is no substantial literature on this subject to date in the PCOS patient cohort, with this being the first randomised study to date. The investigators will discuss the effects of time-restricted eating on insulin levels in the specific population of women with PCOS based on the results.
- Conditions
- PCOS, Hyperinsulinemia, Insulin Resistance
- Being tested
- Time restricted eating, Normal ad libitum diet
- Keywords
- PCOS, Intermittent Fasting, Fasting, Hyperinsulinemia, Insulin Resistance
- Medical subject headings
- Hyperinsulinism, Insulin Resistance, Intermittent Fasting, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time restricted eatingOther
Following a 3 day baseline dietary assessment using the Nutritics 'app', patients will immediately commence time-restricted eating on a 18:6 basis (18 hours fasting, 6 hours eating window) for 12 weeks.
Participants will consume all their meals within a daily 6-hour period of their choosing, and this may change according to patient's lifestyle and preference to reflect a real-world situation. Participants may eat ad libitum / according to appetite during the eating period. Participants will fast for 18 hours per day, consuming only plain water, unflavoured/unsweetened sparkling water, black breakfast tea or black coffee. Alcohol must not be consumed during fasting periods
Dietary intake will again be measured using the Nutritics 'app' midpoint through the 12-week period (week 6 +/- 1 week) and in the last week of the intervention (week 11/12).
Normal ad libitum dietOther
Following a 3-day baseline dietary assessment using the Nutritics 'app', participants with be directed to continue with their usual dietary intake without any time-related restrictions for 12 weeks. There will be no defined eating window and fasting or restrictions regarding types of food or drink consumed.
Dietary intake will again be measured using the Nutritics 'app' midpoint through the 12-week period (week 6 +/- 1 week) and in the last week of the intervention (week 11/12).
| Study group | Role | What they receive |
|---|---|---|
| Time restricted eating | Experimental | Time-restricted eating using 18:6 protocol (12 weeks)
Washout Period (4 weeks)
Crossover to Normal ad libitum diet (12 weeks) Receives: Other: Time restricted eating |
| Normal ad libitum diet | Active comparator | Normal ad libitum dietary patterns without defined eating window, fasting or restrictions on types of food or drink consumed (12 weeks)
Washout Period (4 weeks)
Crossover to time-restricted eating using 18:6 protocol (12 weeks) Receives: Other: Normal ad libitum diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drop-out rate
Assessing intervention feasibility
Measured: 6 weeks
Drop-out rate
Assessing intervention feasibility
Measured: 12 weeks
Adverse outcomes as assessed by CTCAE v4.0
Assessing intervention feasibility
Measured: 6 weeks
Adverse outcomes as assessed by CTCAE v4.0
Assessing intervention feasibility
Measured: 12 weeks
Change in serum insulin
Measured with serum insulin levels to assess effects
Measured: 6 weeks
Change in serum insulin
Measured with serum insulin levels to assess effects
Measured: 12 weeks
Change in food diaries
Assessment of change of eating behaviours
Measured: 6 weeks
Change in food diaries
Assessment of change of eating behaviours
Measured: 12 weeks
Secondary outcomes (46)
Change in insulin resistance
Assessed by Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) and other ratio calculations measuring insulin resistance
Measured: 6 weeks
Change in insulin resistance
Assessed by Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) and other ratio calculations measuring insulin resistance
Measured: 12 weeks
Change in testosterone levels
Assessed by plasma testosterone
Measured: 6 weeks
Change in testosterone levels
Assessed by plasma testosterone
Measured: 12 weeks
Change in free testosterone levels
Assessed by plasma free testosterone
Measured: 6 weeks
Change in free testosterone levels
Assessed by plasma free testosterone
Measured: 12 weeks
Change in dehydroepiandrosterone sulfate (DHEA-S) levels
Assessed by plasma dehydroepiandrosterone sulfate (DHEA-S)
Measured: 6 weeks
Change in dehydroepiandrosterone sulfate (DHEA-S) levels
Assessed by plasma dehydroepiandrosterone sulfate (DHEA-S)
Measured: 12 weeks
Change in androstenedione levels
Assessed by plasma androstenedione
Measured: 6 weeks
Change in androstenedione levels
Assessed by plasma androstenedione
Measured: 12 weeks
Change in sex hormone binding globulin (SHBG) levels
Assessed by plasma sex hormone binding globulin (SHBG)
Measured: 6 weeks
Change in sex hormone binding globulin (SHBG) levels
Assessed by plasma sex hormone binding globulin (SHBG))
Measured: 12 weeks
Change in 17-Hydroxyprogesterone (17-OHP) levels
Assessed by 17-Hydroxyprogesterone (17-OHP)
Measured: 6 weeks
Change in 17-Hydroxyprogesterone (17-OHP) levels
Assessed by 17-Hydroxyprogesterone (17-OHP)
Measured: 12 weeks
Change in appetite
Measured by a validated 10-point visual analogue scale on a scale of 1-10, 1 being not hungry at all and 10 being very hungry
Measured: 6 weeks
Change in appetite
Measured by a validated 10-point visual analogue scale on a scale of 1-10, 1 being not hungry at all and 10 being very hungry
Measured: 12 weeks
Change in markers of satiety
Assess by plasma GLP-1
Measured: 6 weeks
Change in markers of satiety
Assess by plasma GLP-1
Measured: 12 weeks
Change in markers of satiety
Assess by plasma PYY
Measured: 6 weeks
Change in markers of satiety
Assess by plasma PYY
Measured: 12 weeks
Change in markers of satiety
Assess by plasma oxyntomodulin
Measured: 6 weeks
Change in markers of satiety
Assess by plasma oxyntomodulin
Measured: 12 weeks
Change in markers of hunger
Assess by plasma ghrelin
Measured: 6 weeks
Change in markers of hunger
Assess by plasma ghrelin
Measured: 12 weeks
Change in fasting glucose
Assessed in serum glucose measurements
Measured: 6 weeks
Change in fasting glucose
Assessed in serum glucose measurements
Measured: 12 weeks
Change in HbA1c
Assessed in serum HbA1c measurements
Measured: 6 weeks
Change in HbA1c
Assessed in serum HbA1c measurements
Measured: 12 weeks
Change in lipids
Assessed by Lipid profile
Measured: 6 weeks
Change in lipids
Assessed by Lipid profile
Measured: 12 weeks
Change in lipids
Assessed by Lipoprotein lipid A levels
Measured: 6 weeks
Change in lipids
Assessed by Lipoprotein lipid A levels
Measured: 12 weeks
Change in lipids
Assessed by Apolipoprotein A1 levels
Measured: 6 weeks
Change in lipids
Assessed by Apolipoprotein A1 levels
Measured: 12 weeks
Change in lipids
Assessed by Apolipoprotein B levels
Measured: 6 weeks
Change in lipids
Assessed by Apolipoprotein B levels
Measured: 12 weeks
Change in body weight
Body weight (kg)
Measured: 6 weeks
Change in body weight
Body weight (kg)
Measured: 12 weeks
Change in body mass index
BMI (kg/m2)
Measured: 6 weeks
Change in body mass index
BMI (kg/m2)
Measured: 12 weeks
Change in anthropometric measurements (waist circumference)
Waist circumference (cm)
Measured: 6 weeks
Change in anthropometric measurements (waist circumference)
Waist circumference (cm)
Measured: 12 weeks
Change in anthropometric measurements (waist-hip ratio)
Waist-hip ratio
Measured: 6 weeks
Change in anthropometric measurements (waist-hip ratio)
Waist-hip ratio
Measured: 12 weeks
Change in dietary intake
Assessed using interval dietary assessments with Nutritics 'app'
Measured: 6 weeks
Change in dietary intake
Assessed using interval dietary assessments with Nutritics 'app'
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start5 May 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for PCOSStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruairí Floyd
- Sponsor type
- University, hospital or other
- Collaborators
- Tallaght University Hospital
- Responsible party
- Sponsor-investigator, Ruairí Floyd, Tallaght University Hospital
- Investigators
- Lucy-Ann Behan, MD, Principal investigator, Robert Graves Institute of Endocrinology, Tallaght University HospitalSinead Duggan, R.D. PhD, Study director, University of Dublin, Trinity College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05126199
- Sponsor's protocol ID
- TimeMAP
- Acronym
- TimeMAP
- Status last verified
- Sep 2022
- First submitted
- 28 Oct 2021
- Last updated
- 19 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Asemi Z, Samimi M, Taghizadeh M, Esmaillzadeh A. Effects of Ramadan Fasting on Glucose Homeostasis, Lipid Profiles, Inflammation and Oxidative Stress in Women with Polycystic Ovary Syndrome in Kashan, Iran. Arch Iran Med. 2015 Dec;18(12):806-10.
PubMed 26621011Teede HJ, Misso ML, Costello MF, Dokras A, Laven J, Moran L, Piltonen T, Norman RJ; International PCOS Network. Recommendations from the international evidence-based guideline for the assessment and management of polycystic ovary syndrome. Fertil Steril. 2018 Aug;110(3):364-379. doi: 10.1016/j.fertnstert.2018.05.004. Epub 2018 Jul 19.
PubMed 30033227Anton SD, Moehl K, Donahoo WT, Marosi K, Lee SA, Mainous AG 3rd, Leeuwenburgh C, Mattson MP. Flipping the Metabolic Switch: Understanding and Applying the Health Benefits of Fasting. Obesity (Silver Spring). 2018 Feb;26(2):254-268. doi: 10.1002/oby.22065. Epub 2017 Oct 31.
PubMed 29086496Li C, Xing C, Zhang J, Zhao H, Shi W, He B. Eight-hour time-restricted feeding improves endocrine and metabolic profiles in women with anovulatory polycystic ovary syndrome. J Transl Med. 2021 Apr 13;19(1):148. doi: 10.1186/s12967-021-02817-2.
PubMed 33849562de Cabo R, Mattson MP. Effects of Intermittent Fasting on Health, Aging, and Disease. N Engl J Med. 2019 Dec 26;381(26):2541-2551. doi: 10.1056/NEJMra1905136. No abstract available.
PubMed 31881139Albosta M, Bakke J. Intermittent fasting: is there a role in the treatment of diabetes? A review of the literature and guide for primary care physicians. Clin Diabetes Endocrinol. 2021 Feb 3;7(1):3. doi: 10.1186/s40842-020-00116-1.
PubMed 33531076Zangeneh F, Salman Yazdi R, Naghizadeh MM, Abedinia N. Effect of Ramadan Fasting on Stress Neurohormones in Women with Polycystic Ovary Syndrome. J Family Reprod Health. 2015 Jun;9(2):51-7.
PubMed 26175759Pellegrini M, Cioffi I, Evangelista A, Ponzo V, Goitre I, Ciccone G, Ghigo E, Bo S. Effects of time-restricted feeding on body weight and metabolism. A systematic review and meta-analysis. Rev Endocr Metab Disord. 2020 Mar;21(1):17-33. doi: 10.1007/s11154-019-09524-w.
PubMed 31808043Floyd R, Dyer A, Gibney J, Alawami F, Owens L, Phelan N, Rakovac A, Swan P, LeRoux CW, Behan LA, Duggan SN. Time-Restricted Eating to Improve Metabolic Abnormalities in Polycystic Ovarian Syndrome (TimeMAP). Clin Endocrinol (Oxf). 2026 Apr;104(4):327-342. doi: 10.1111/cen.70094. Epub 2026 Jan 14.
PubMed 41532393
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Time-restricted Eating on Insulin Levels and Other Metabolic Abnormalities in Polycystic Ovarian Syndrome: A Randomised Feasibility Study of Real-world Clinical Advice
- ClinicalTrials.gov ID
- NCT05126199
- Acronym / sponsor ID
- TimeMAP / TimeMAP
- Conditions
- PCOS, Hyperinsulinemia, Insulin Resistance
- Keywords
- PCOS, Intermittent Fasting, Fasting, Hyperinsulinemia, Insulin Resistance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ruairí FloydUniversity, hospital or other
- Collaborators
- Tallaght University Hospital
- Study start
- 5 May 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 18 Nov 2021 (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.
Polycystic ovarian syndrome (PCOS) is associated with metabolic symptoms such as hyperinsulinemia. Time-restricted eating may reduce serum insulin and improve insulin resistance in patients with PCOS. Currently, there are few studies investigating time-restricted eating in patients with PCOS. The investigators plan to test the feasibility of time-restricted eating in the management of PCOS by means of a real-world clinical intervention. The investigators will determine if an 18:6 eating protocol reduces insulin levels by means of a randomised controlled crossover trial.
Detailed description
Background: Polycystic ovarian syndrome (PCOS) is the most common reproductive endocrinopathy in women of reproductive age with many associated metabolic symptoms, in particular hyperinsulinemia, insulin resistance and a high lifetime risk of type 2 diabetes mellitus. The effects of time-restricted eating on metabolic profiles have been investigated in many endocrinopathies, but there are minimal data in PCOS.
Methods: This study will investigate the feasibility of time-restricted eating in the management of PCOS, and its effects on insulin levels and other metabolic parameters.
To achieve this, the investigators will recruit 20 patients with PCOS (normal weight, overweight, obese).
In a randomised cross-over design, participants will be observed for two consecutive 12 week periods (with a 4 weeks washout period in between) following either 'time-restricted eating' or 'usual eating', detailed below.
- 18:6 protocol: 18 hours of fasting and a 6-hours eating window, with no other specific dietary advice. Participants choose their own 6-hour period according to their lifestyle and preference.
- Usual eating: follow usual eating patterns, no time restriction, no other dietary advice
When fasting, participants are permitted to consume plain water, unflavoured/unsweetened sparkling water, black breakfast tea and black coffee.
Dietary intake will be determined at baseline, at midpoint of each study arm, and at the end of the study using Nutritics software. Participants will self-record dietary intake using the Nutritics 'app'.
The primary endpoints will be serum insulin and feasibility of the intervention as well as safety, acceptability, and compliance with time-restricted eating.
Secondary endpoints will be insulin resistance (Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)), androgens (testosterone, free testosterone, dehydroepiandrosterone sulfate (DHEA-S), androstenedione, 17-Hydroxyprogesterone (17-OHP) and sex hormone binding globulin (SHBG)), appetite (10-point visual analogue scale), hunger/satiety (glucagon-like peptide 1 (GLP-1), grehlin, PYY and oxyntomodulin, fasting glucose, HbA1c, lipid profile, lipoprotein lipid A, apolipoprotein A1, apolipoprotein B, anthropometrics (weight, body mass index, hip and waist circumference), dietary intake (calorie and macronutrient intake; micronutrient intake including iron, calcium; dietary pattern including timing).
Results: Safety and acceptability will be measured by adverse event reporting and measurement of adherence. Paired t-test will be used to assess between baseline and post intervention measurements. Results considered statistically significant if p<0.05.
Discussion: Time-restricted eating has potential to aid in improvement of insulin resistance in patients with PCOS based on studies in other populations. There is no substantial literature on this subject to date in the PCOS patient cohort, with this being the first randomised study to date. The investigators will discuss the effects of time-restricted eating on insulin levels in the specific population of women with PCOS based on the results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Time restricted eating | Experimental | Other: Time restricted eatingTime-restricted eating using 18:6 protocol (12 weeks) Washout Period (4 weeks) Crossover to Normal ad libitum diet (12 weeks) |
| Normal ad libitum diet | Active comparator | Other: Normal ad libitum dietNormal ad libitum dietary patterns without defined eating window, fasting or restrictions on types of food or drink consumed (12 weeks) Washout Period (4 weeks) Crossover to time-restricted eating using 18:6 protocol (12 weeks) |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adult women of reproductive age with confirmed diagnosis of PCOS (Rotterdam Criteria, including at least 2 of 3 characteristics: oligomenorrhea, clinical and/or biochemical hyperandrogenism and ultrasound criteria)
- No BMI restriction
- Able and willing to provide explicit, informed consent
Key exclusion criteria (9 listed)
- Type 1 diabetes, medication-controlled type 2 diabetes
- Pregnancy
- Currently participating in weight loss programme, or reported weight change in last 3 months (>5% of current body weight)
- Documented history of eating disorder
- Ovulation medication, such as clomiphene citrate
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 eatingFollowing a 3 day baseline dietary assessment using the Nutritics 'app', patients will immediately commence time-restricted eating on a 18:6 basis (18 hours fasting, 6 hours eating window) for 12 weeks. Participants will consume all their meals within a daily 6-hour period of their choosing, and this may change according to patient's lifestyle and preference to reflect a real-world situation. Participants may eat ad libitum / according to appetite during the eating period. Participants will fast for 18 hours per day, consuming only plain water, unflavoured/unsweetened sparkling water, black breakfast tea or black coffee. Alcohol must not be consumed during fasting periods Dietary intake will again be measured using the Nutritics 'app' midpoint through the 12-week period (week 6 +/- 1 week) and in the last week of the intervention (week 11/12). | Other | Time restricted eating |
| Normal ad libitum dietFollowing a 3-day baseline dietary assessment using the Nutritics 'app', participants with be directed to continue with their usual dietary intake without any time-related restrictions for 12 weeks. There will be no defined eating window and fasting or restrictions regarding types of food or drink consumed. Dietary intake will again be measured using the Nutritics 'app' midpoint through the 12-week period (week 6 +/- 1 week) and in the last week of the intervention (week 11/12). | Other | Normal ad libitum diet |
Primary outcome
Drop-out rate
Time frame: 6 weeks
Assessing intervention feasibility
Drop-out rate
Time frame: 12 weeks
Assessing intervention feasibility
Adverse outcomes as assessed by CTCAE v4.0
Time frame: 6 weeks
Assessing intervention feasibility
Adverse outcomes as assessed by CTCAE v4.0
Time frame: 12 weeks
Assessing intervention feasibility
Change in serum insulin
Time frame: 6 weeks
Measured with serum insulin levels to assess effects
Change in serum insulin
Time frame: 12 weeks
Measured with serum insulin levels to assess effects
Change in food diaries
Time frame: 6 weeks
Assessment of change of eating behaviours
Change in food diaries
Time frame: 12 weeks
Assessment of change of eating behaviours
46 secondary outcomes
Change in insulin resistance
Time frame: 6 weeks
Change in insulin resistance
Time frame: 12 weeks
Change in testosterone levels
Time frame: 6 weeks
Change in testosterone levels
Time frame: 12 weeks
Change in free testosterone levels
Time frame: 6 weeks
Change in free testosterone levels
Time frame: 12 weeks
Change in dehydroepiandrosterone sulfate (DHEA-S) levels
Time frame: 6 weeks
Change in dehydroepiandrosterone sulfate (DHEA-S) levels
Time frame: 12 weeks
Change in androstenedione levels
Time frame: 6 weeks
Change in androstenedione levels
Time frame: 12 weeks
Change in sex hormone binding globulin (SHBG) levels
Time frame: 6 weeks
Change in sex hormone binding globulin (SHBG) levels
Time frame: 12 weeks
Change in 17-Hydroxyprogesterone (17-OHP) levels
Time frame: 6 weeks
Change in 17-Hydroxyprogesterone (17-OHP) levels
Time frame: 12 weeks
Change in appetite
Time frame: 6 weeks
Change in appetite
Time frame: 12 weeks
Change in markers of satiety
Time frame: 6 weeks
Change in markers of satiety
Time frame: 12 weeks
Change in markers of satiety
Time frame: 6 weeks
Change in markers of satiety
Time frame: 12 weeks
Change in markers of satiety
Time frame: 6 weeks
Change in markers of satiety
Time frame: 12 weeks
Change in markers of hunger
Time frame: 6 weeks
Change in markers of hunger
Time frame: 12 weeks
Change in fasting glucose
Time frame: 6 weeks
Change in fasting glucose
Time frame: 12 weeks
Change in HbA1c
Time frame: 6 weeks
Change in HbA1c
Time frame: 12 weeks
Change in lipids
Time frame: 6 weeks
Change in lipids
Time frame: 12 weeks
Change in lipids
Time frame: 6 weeks
Change in lipids
Time frame: 12 weeks
Change in lipids
Time frame: 6 weeks
Change in lipids
Time frame: 12 weeks
Change in lipids
Time frame: 6 weeks
Change in lipids
Time frame: 12 weeks
Change in body weight
Time frame: 6 weeks
Change in body weight
Time frame: 12 weeks
Change in body mass index
Time frame: 6 weeks
Change in body mass index
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2022.
- Background: PubMed 26621011Asemi Z, Samimi M, Taghizadeh M, Esmaillzadeh A. Effects of Ramadan Fasting on Glucose Homeostasis, Lipid Profiles, Inflammation and Oxidative Stress in Women with Polycystic Ovary Syndrome in Kashan, Iran. Arch Iran Med. 2015 Dec;18(12):806-10.
- Background: PubMed 30033227Teede HJ, Misso ML, Costello MF, Dokras A, Laven J, Moran L, Piltonen T, Norman RJ; International PCOS Network. Recommendations from the international evidence-based guideline for the assessment and management of polycystic ovary syndrome. Fertil Steril. 2018 Aug;110(3):364-379. doi: 10.1016/j.fertnstert.2018.05.004. Epub 2018 Jul 19.
- Background: PubMed 29086496Anton SD, Moehl K, Donahoo WT, Marosi K, Lee SA, Mainous AG 3rd, Leeuwenburgh C, Mattson MP. Flipping the Metabolic Switch: Understanding and Applying the Health Benefits of Fasting. Obesity (Silver Spring). 2018 Feb;26(2):254-268. doi: 10.1002/oby.22065. Epub 2017 Oct 31.
- Background: PubMed 33849562Li C, Xing C, Zhang J, Zhao H, Shi W, He B. Eight-hour time-restricted feeding improves endocrine and metabolic profiles in women with anovulatory polycystic ovary syndrome. J Transl Med. 2021 Apr 13;19(1):148. doi: 10.1186/s12967-021-02817-2.
- Background: PubMed 31881139de Cabo R, Mattson MP. Effects of Intermittent Fasting on Health, Aging, and Disease. N Engl J Med. 2019 Dec 26;381(26):2541-2551. doi: 10.1056/NEJMra1905136. No abstract available.
- Background: PubMed 33531076Albosta M, Bakke J. Intermittent fasting: is there a role in the treatment of diabetes? A review of the literature and guide for primary care physicians. Clin Diabetes Endocrinol. 2021 Feb 3;7(1):3. doi: 10.1186/s40842-020-00116-1.
- Background: PubMed 26175759Zangeneh F, Salman Yazdi R, Naghizadeh MM, Abedinia N. Effect of Ramadan Fasting on Stress Neurohormones in Women with Polycystic Ovary Syndrome. J Family Reprod Health. 2015 Jun;9(2):51-7.
- Background: PubMed 31808043Pellegrini M, Cioffi I, Evangelista A, Ponzo V, Goitre I, Ciccone G, Ghigo E, Bo S. Effects of time-restricted feeding on body weight and metabolism. A systematic review and meta-analysis. Rev Endocr Metab Disord. 2020 Mar;21(1):17-33. doi: 10.1007/s11154-019-09524-w.
- Derived from this study: PubMed 41532393Floyd R, Dyer A, Gibney J, Alawami F, Owens L, Phelan N, Rakovac A, Swan P, LeRoux CW, Behan LA, Duggan SN. Time-Restricted Eating to Improve Metabolic Abnormalities in Polycystic Ovarian Syndrome (TimeMAP). Clin Endocrinol (Oxf). 2026 Apr;104(4):327-342. doi: 10.1111/cen.70094. Epub 2026 Jan 14.
- BDA The Association of UK Dieticians - Polycystic Ovary Syndrome (PCOS) Food Fact SheetLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Lucy-Ann Behan, MD principal investigator
Robert Graves Institute of Endocrinology, Tallaght University Hospital
Sinead Duggan, R.D. PhD study director
University of Dublin, Trinity College
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 and Normal ad libitum diet in people with PCOS and Hyperinsulinemia, run by Ruairí Floyd at 1 site in Ireland.
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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 19 Sep 2022. 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 Ireland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruairí Floyd, BSc BMBS ((01) 414 2000, floydr@tcd.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drop-out rate (time frame: 6 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05126199, which also lists 9 linked publications.
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 19 Sep 2022.