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Time-Restricted Eating as a Dietary Intervention for Polyendocrine Metabolic Ovarian Syndrome (PMOS): Protocol for a Randomized Controlled Trial

2026년 10월 13일 업데이트: Joanna Bajerska

Polyendocrine Metabolic Ovarian Syndrome (PMOS), previously known as PCOS, is a common endocrine disorder associated with metabolic, reproductive, and hormonal abnormalities. Growing evidence suggests that time-restricted eating (TRE) may improve body weight regulation, insulin sensitivity, hormonal balance, and menstrual function in women with PMOS. However, the mechanisms underlying these benefits remain unclear, particularly regarding the role of the gut microbiota and neurohormonal pathways.

This randomized controlled trial will investigate whether combining an 8-hour TRE regimen with Healthy Eating Plate dietary recommendations provides greater benefits than dietary recommendations alone. Women aged 18-40 years with PMOS and overweight or obesity will participate in an 8-week intervention. The study will assess changes in gut microbiota composition, microbial metabolites, metabolic health, hormonal profile, neurohormonal markers, and body composition.

The study is expected to provide novel insights into the interactions between meal timing, gut microbiota, neuroendocrine regulation, and clinical manifestations of PMOS, contributing to the development of more effective and sustainable dietary strategies for this condition.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

Polyendocrine Metabolic Ovarian Syndrome (PMOS), formerly referred to as Polycystic Ovary Syndrome (PCOS), affects a substantial proportion of women of reproductive age and is characterized by reproductive, endocrine, and metabolic disturbances. In addition to hormonal dysregulation involving the hypothalamic-pituitary-ovarian axis, women with PMOS frequently experience obesity, insulin resistance, hyperinsulinemia, menstrual irregularities, and impaired fertility. Recent research indicates that the gut microbiota and the gut-brain axis may play important roles in the development and progression of the syndrome. Gut-derived metabolites, including short-chain fatty acids, lipopolysaccharides, and neuroactive compounds such as GABA, may influence both metabolic and reproductive functions.

Time-restricted eating (TRE), an eating pattern that limits food intake to a specific daily time window without necessarily restricting calories, has emerged as a promising intervention for individuals with metabolic disorders. Previous studies suggest that TRE may improve insulin sensitivity, glucose metabolism, lipid profile, body weight, and reproductive outcomes in women with PMOS. Furthermore, evidence from both human and animal studies indicates that TRE may beneficially alter the composition and diversity of the gut microbiota. Despite these findings, the biological mechanisms linking meal timing, gut microbiota changes, neurohormonal regulation, and clinical improvements in PMOS remain insufficiently understood.

To address this knowledge gap, this study has been designed as a two-arm randomized controlled trial involving women aged 18 to 40 years with PMOS and a BMI between 25 and 40 kg/m². Participants will be randomly assigned to either a control group following Healthy Eating Plate recommendations without meal-timing restrictions or an intervention group following the same dietary recommendations combined with a 16:8 TRE regimen, restricting food intake to an 8-hour daily eating window. The intervention will last eight weeks.

The primary objective is to determine whether TRE can induce favorable changes in intestinal microbiota composition and microbial metabolites. Secondary outcomes include changes in glucose and lipid metabolism, insulin resistance, hormonal profile, neurohormonal markers such as kisspeptin and GABA, anthropometric measurements, body composition, and energy intake. Comprehensive assessments will include blood analyses, stool microbiota sequencing, metabolic and hormonal measurements, dietary intake evaluation, and physical activity assessment.

A major strength of the study is its ability to isolate the effect of meal timing because both groups receive identical dietary quality recommendations. This design allows researchers to evaluate whether the timing of food consumption independently contributes to improvements in PMOS-related outcomes. By integrating microbiological, metabolic, and neuroendocrine assessments, the trial is expected to provide a comprehensive understanding of the gut microbiota-brain-reproductive axis in PMOS.

The researchers anticipate that this will be one of the largest studies examining TRE in women with PMOS. The findings may help clarify the mechanisms through which TRE influences metabolic and reproductive health and support the development of evidence-based, practical, and sustainable dietary recommendations for women affected by this condition.

연구 유형

중재적

등록 (추정된)

84

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 폴란드
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, 폴란드, 60-637
        • Poznań University of Life Sciences
        • 연락하다:
        • 연락하다:
        • 수석 연구원:
          • Joanna Bajerska, Assoc. Prof.
        • 부수사관:
          • Joanna M Pieczyńska-Zając, M.Sc.
        • 부수사관:
          • Karolina Łagowska, PhD
        • 부수사관:
          • Aleksandra Bykowska-Derda, PhD
        • 부수사관:
          • Paweł Antoni Kołodziejski, Prof.
        • 부수사관:
          • Ewa Pruszyńska-Oszmałek, PhD
        • 부수사관:
          • Sławomira Drzymała-Czyż, PhD

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

여성

설명

Eligible participants will be women aged 18-40 years with a BMI of 25-40 kg/m² and a physician-established diagnosis of PMOS established according to the 2023 International Evidence-based Guideline for the Assessment and Management of Polycystic Ovary Syndrome . The exclusion criteria, assessed at the screening visit by structured interview and review of medical documentation, will be:

  • use within the previous 3 months of medications or supplements affecting carbohydrate or lipid metabolism, body weight, reproductive hormones including hormonal contraceptives, antiandrogens, glucocorticoids, weight-loss medications, insulin-sensitizing agents (e.g., metformin, inositols), probiotic or prebiotic supplements;
  • antibiotic treatment within the previous 3 months
  • smoking within the previous 3 months or alcohol consumption >100 g/week;
  • participation in competitive sports or structured athletic training;
  • significant body weight fluctuations (>5%) during the 3 months preceding study enrollment;
  • current or past diagnosis of anorexia nervosa, bulimia nervosa, binge eating disorder, or other clinically significant eating disorders;
  • pregnancy or breastfeeding;
  • shift work or night work;
  • diagnosed type 1 or type 2 diabetes.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Time-restricted eating group (TRE group)

Participants in the TRE group will be instructed to consume all foods and energy-containing beverages between 9:00 a.m. and 5:00 p.m. (8-hour eating window) and fast for the remaining 16 hours until the following day (a 16:8 protocol). Participants randomized to the intervention group will receive the same dietary recommendations but will additionally be instructed to follow a time-restricted eating (TRE) regimen.
행동: Time-restricted eating

Time-restricted eating (TRE) is a dietary pattern where food intake is restricted to 8 hours of the day with no limitation on nutrient quality or quantity. Participants assigned to the intervention group will eat their usual diet from 9:00 a.m. to 5:00 p.m., and then fast until the next day (protocol 8/16). During the 16-hour fast, only hot and cold drinks will be allowed, i.e. coffee, tea or tea and water, but all products and dishes with energy value (including coffee cream, sweet teas, alcohol, snacks, etc.) will be prohibited. The TRE protocol will be implemented 7 days a week for a period of 2 months (8 weeks).
간섭 없음: Non-fasting group

Participants assigned to the control group will receive dietary advice based on the Healthy Eating Plate model and will be instructed to consume their diet ad libitum, without prescribed energy restriction.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in glucose metabolism - Homeostatic Model Assessment of Insulin Resistance
기간: Week 0 (pre-intervention) - week 8 (post-intervention)

Insulin resistance will be evaluated using the Homeostasis ModelAssessment Method. The HOMA-IR (Homeostatic Model Assessment of Insulin Resistance) will be calculated using the following formula: HOMA - IR = fasting glucose [mmol/L] × fasting insulin [μIU/mL]/22.5
Week 0 (pre-intervention) - week 8 (post-intervention)

2차 결과 측정

결과 측정
측정값 설명
기간
Change in energy consumption
기간: Week 0 (pre-intervention) - week 8 (post-intervention)

Dietary intake will be assessed using a validated 72-item Semi-Quantitative Food Frequency Questionnaire (72-item SQ-FFQ) available on the DietTools4U platform and a 3-day dietary record (two weekdays and one weekend day). The use of these complementary methods will enable both the assessment of habitual dietary patterns and the detailed evaluation of recent food intake.
Week 0 (pre-intervention) - week 8 (post-intervention)
Change in body composition
기간: Week 0 (pre-intervention), week 4, week 8 (post-intervention)

Body composition will be measured using dual-energy X-ray absorptiometry (DXA) as a method that uses the phenomenon of weakening the beam of ionizing radiation passing through tissues of various densities. This method is safe and non-invasive. The mass of adipose tissue, including visceral fat tissue, the mass of lean tissue are measured (expressed in the same unit - kilograms)
Week 0 (pre-intervention), week 4, week 8 (post-intervention)
Change in glucose metabolism - glucose concentration
기간: Week 0 (pre-intervention) - week 8 (post-intervention)

Blood will be collected four times from the antecubital vein on an empty stomach, into test tubes with clotting granules (a single sample will amount to a total of 18 ml). The serum will be obtained by centrifugation of a venous blood clot. The glucose will be determined using standard enzymatic colorimetric methods on an automated biochemical analyzer in a certified external diagnostic laboratory (expressed in the unit - mmol/L).
Week 0 (pre-intervention) - week 8 (post-intervention)
Change in glucose metabolism - insulin concentration
기간: Week 0 (pre-intervention) - week 8 (post-intervention)

Blood will be collected four times from the antecubital vein on an empty stomach, into test tubes with clotting granules (a single sample will amount to a total of 18 ml). The serum will be obtained by centrifugation of a venous blood clot. The insulin concentration will be performed using the ELISA enzyme-linked immunosorbent assay (expressed in the unit - μIU/mL).
Week 0 (pre-intervention) - week 8 (post-intervention)
Change in lipid profile
기간: Week 0 (pre-intervention) - week 8 (post-intervention)

Blood will be collected four times from the antecubital vein on an empty stomach, into test tubes with clotting granules (a single sample will amount to a total of 18 ml). The serum will be obtained by centrifugation of a venous blood clot. Total cholesterol (T-C), low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C) and triglycerides concentrations will be using standard enzymatic colorimetric methods on an automated biochemical analyzer in a certified external diagnostic laboratory. The nonHDL-C parameter will be calculated using the formula: nonHDL-C = T-C - HDL-C (expressed in the same unit - mg/dl or mmol/l).
Week 0 (pre-intervention) - week 8 (post-intervention)
Change in selected hormonal parameters
기간: Week 0 (pre-intervention) - week 8 (post-intervention)

Blood will be collected four times from the antecubital vein on an empty stomach, into test tubes with clotting granules (a single sample will amount to a total of 18 ml). The serum will be obtained by centrifugation of a venous blood clot. Hormonal parameters (FSH, LH, testosterone, SHBG), will be performed using the ELISA enzyme-linked immunosorbent assay (expressed in the same unit - pg/ml)
Week 0 (pre-intervention) - week 8 (post-intervention)
Change in circumferences
기간: Week 0 (pre-intervention), week 4, week 8 (post-intervention)

Waist and hip measurements will be taken using an elastic tape. Waist circumference measurement - the tape is placed horizontally or slightly obliquely halfway between the lower edge of the ribs and the upper crest of the ilium. Measurement performed during apnea.
Week 0 (pre-intervention), week 4, week 8 (post-intervention)
Change in body weight
기간: Week 0 (pre-intervention), week 4, week 8 (post-intervention)

Body weight measurement in a standing position, without shoes, in light clothing, on an electronic scale with an accuracy of 0.1 kg.
Week 0 (pre-intervention), week 4, week 8 (post-intervention)
Change in bone density
기간: Week 0 (pre-intervention), week 4, week 8 (post-intervention)

Bone density will be measured using dual-energy X-ray absorptiometry (DXA) as a method that uses the phenomenon of weakening the beam of ionizing radiation passing through tissues of various densities. This method is safe and non-invasive.
Week 0 (pre-intervention), week 4, week 8 (post-intervention)
Change in circulating GABA and kisspeptin concentrations
기간: Week 0 (pre-intervention) - week 8 (post-intervention)

Blood will be collected four times from the antecubital vein on an empty stomach, into test tubes with clotting granules (a single sample will amount to a total of 18 ml). The serum will be obtained by centrifugation of a venous blood clot. Kisspeptin and gamma-aminobutyric acid concentrations will be performed using the ELISA enzyme-linked immunosorbent assay.
Week 0 (pre-intervention) - week 8 (post-intervention)

기타 결과 측정

결과 측정
측정값 설명
기간
Change in composition of the intestinal microbiota
기간: Week 0 (pre-intervention) - week 8 (post-intervention)

Participants will be asked to provide stool samples at baseline and at the final visit and will receive containers with preservative liquid. Bacterial DNA will be isolated from the provided stool samples using the QIAmp Fast DNA Stool Mini Kit. Then, the DNA will be properly secured and sent to an external company, Genomed S.A. (Warsaw, Poland), where microbiota assessment will be carried out using 16S rRNA gene sequencing targeting the V3-V4 region.
Week 0 (pre-intervention) - week 8 (post-intervention)
Change in lipopolysaccharide concentration in blood
기간: Week 0 (pre-intervention) - week 8 (post-intervention)

Blood will be collected four times from the antecubital vein on an empty stomach, into test tubes with clotting granules (a single sample will amount to a total of 18 ml). The serum will be obtained by centrifugation of a venous blood clot. Serum lipopolysaccharide (LPS) concentrations will be assessed using an enzyme-linked immunosorbent assay (ELISA).
Week 0 (pre-intervention) - week 8 (post-intervention)
Change in Short Chain Fatty Acids concentration in stool
기간: Week 0 (pre-intervention) - week 8 (post-intervention)

Participants will be asked to provide stool samples at baseline and at the final visit and will receive containers with preservative liquid. Quantitative and qualitative determination of short-chain fatty acids in feces will be performed by gas chromatography with flame ionization detection (GC-FID). The research will be carried out at the Department of Bromatology, Poznan University of Medical Sciences.
Week 0 (pre-intervention) - week 8 (post-intervention)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Joanna Bajerska

수사관

  • 연구 의자: Agata Chmurzyńska, Prof., Department of Human Nutrition and Dietetics, Poznań University of Life Sciences

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2027년 1월 9일

기본 완료 (추정된)

2027년 12월 31일

연구 완료 (추정된)

2028년 3월 31일

연구 등록 날짜

최초 제출

2024년 1월 3일

QC 기준을 충족하는 최초 제출

2024년 1월 3일

처음 게시됨 (실제)

2024년 1월 12일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 10월 16일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 10월 13일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 646/23

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

Numerical data, statistics and graphs data will be deposited in the Open Data Repository RepOD - the PULS institutional repository, and made publicly available in the Repository at the latest at the time when the publication presenting research data is published including a maximum 36-month embargo period due to the requirements and specifics of the publication of the article presenting the research results. Upon publication, the embargo will be lifted immediately.

Unless there is a clear indication to the contrary, the data will be made available in the RepOD repository under a CC BY 4.0 license. Data not stored in RepOD will be stored long term as described in 3.1.

Raw and processed data will be stored for at least 10 years. Personal data will be deleted after the pseudonymization process.

IPD 공유 기간

IPD data will be made available after publication of all planned articles presenting the results of the planned experiment for a period of 10 years.

IPD 공유 액세스 기준

All persons having access to data have to be authorised to process personal data. A secured work e-mail is used for correspondence. Access to collected and processed sensitive data will be limited solely to the group of authorised users. The Head of the project authorises individuals to have access to data.

The e-mail requesting access to the IPD should include your name and surname, academic degree and affiliation. Data will only be made available after the person's identity has been verified and the purpose of using the data is clear (e.g. meta-analysis). Then, the data owner will verify the need to have the data and send it in a password-protected form. All data will be pseudonymized.

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • ICF
  • CSR

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다