Time-restricted Eating to Improve Metabolic Abnormalities in Polycystic Ovarian Syndrome

NCT05126199 | Unknown

• 1 other identifier: TimeMAP
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

PCOS; Hyperinsulinemia; Insulin Resistance

Keywords

PCOS; Intermittent Fasting; Fasting; Hyperinsulinemia; Insulin Resistance

Outcome Measures

Primary Outcomes (8)

• Drop-out rate

  Assessing intervention feasibility

  6 weeks

• Drop-out rate

  Assessing intervention feasibility

  12 weeks

• Adverse outcomes as assessed by CTCAE v4.0

  Assessing intervention feasibility

  6 weeks

• Adverse outcomes as assessed by CTCAE v4.0

  Assessing intervention feasibility

  12 weeks

• Change in serum insulin

  Measured with serum insulin levels to assess effects

  6 weeks

• Change in serum insulin

  Measured with serum insulin levels to assess effects

  12 weeks

• Change in food diaries

  Assessment of change of eating behaviours

  6 weeks

• Change in food diaries

  Assessment of change of eating behaviours

  12 weeks

Secondary Outcomes (46)

• Change in insulin resistance

  6 weeks

• Change in insulin resistance

  12 weeks

• Change in testosterone levels

  6 weeks

• Change in testosterone levels

  12 weeks

• Change in free testosterone levels

  6 weeks

Study Arms (2)

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)

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)

Other: Normal ad libitum diet

Interventions

Time restricted eating OTHER

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).

Time restricted eating

Normal ad libitum diet OTHER

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).

Normal ad libitum diet

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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))
• 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

Sponsors & Collaborators

• Ruairí Floyd: lead
• Tallaght University Hospital: collaborator

Study Sites (1)

Robert Graves Institute of Endocrinology, Tallaght University Hospital

Dublin, Leinster, D24 NR0A, Ireland

RECRUITING

Related Publications (9)

• 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.

  PMID: 26621011 BACKGROUND

• Teede 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.

  PMID: 30033227 BACKGROUND

• Anton 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.

  PMID: 29086496 BACKGROUND

• Li 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.

  PMID: 33849562 BACKGROUND

• de 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.

  PMID: 31881139 BACKGROUND

• Albosta 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.

  PMID: 33531076 BACKGROUND

• Zangeneh 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.

  PMID: 26175759 BACKGROUND

• Pellegrini 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.

  PMID: 31808043 BACKGROUND

• Floyd 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 Jan 14. doi: 10.1111/cen.70094. Online ahead of print.

  PMID: 41532393 DERIVED

Related Links

• BDA The Association of UK Dieticians - Polycystic Ovary Syndrome (PCOS) Food Fact Sheet

MeSH Terms

Conditions

Hyperinsulinism; Insulin Resistance; Intermittent Fasting; Fasting

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Feeding Behavior; Behavior

Study Officials

• Lucy-Ann Behan, MD

  Robert Graves Institute of Endocrinology, Tallaght University Hospital

  PRINCIPAL INVESTIGATOR

• Sinead Duggan, R.D. PhD

  University of Dublin, Trinity College

  STUDY DIRECTOR

Central Study Contacts

Ruairí Floyd, BSc BMBS

CONTACT

(01) 414 2000; floydr@tcd.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Study Co-ordinator and Researcher

Study Record Dates

• First Submitted: October 28, 2021
• First Posted: November 18, 2021
• Study Start: May 5, 2021
• Primary Completion: December 31, 2022
• Study Completion: January 31, 2023
• Last Updated: September 19, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)