Time-Restricted Eating as a Dietary Intervention for Polyendocrine Metabolic Ovarian Syndrome (PMOS): Protocol for a Randomized Controlled Trial
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Joanna Bajerska, Assoc. Prof.
- 電話番号：+ 48 61 8466056
- メール：Joanna.bajerska@up.poznan.pl
研究連絡先のバックアップ
- 名前：Joanna M Pieczyńska-Zając, M.Sc.
- 電話番号：+48 660950786
- メール：joanna.pieczynska@up.poznan.pl
研究場所
-
-
Greater Poland Voivodeship
-
Poznan、Greater Poland Voivodeship、ポーランド、60-637
- Poznań University of Life Sciences
-
コンタクト：
- Joanna Bajerska, Assoc. Prof.
- 電話番号：+ 48 61 8466056
- メール：Joanna.bajerska@up.poznan.pl
-
コンタクト：
- Joanna M Pieczyńska-Zając, M.Sc.
- 電話番号：+48 660950786
- メール：joanna.pieczynska@up.poznan.pl
-
主任研究者：
- Joanna Bajerska, Assoc. Prof.
-
副調査官：
- Joanna M Pieczyńska-Zając, M.Sc.
-
副調査官：
- Karolina Łagowska, PhD
-
副調査官：
- Aleksandra Bykowska-Derda, PhD
-
副調査官：
- Paweł Antoni Kołodziejski, Prof.
-
副調査官：
- Ewa Pruszyńska-Oszmałek, PhD
-
副調査官：
- Sławomira Drzymała-Czyż, PhD
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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. |
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). |
|
介入なし：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in glucose metabolism - Homeostatic Model Assessment of Insulin Resistance
時間枠：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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in energy consumption
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in composition of the intestinal microbiota
時間枠：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
時間枠：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
時間枠：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)
|
協力者と研究者
スポンサー
捜査官
- スタディチェア：Agata Chmurzyńska, Prof.、Department of Human Nutrition and Dietetics, Poznań University of Life Sciences
出版物と役立つリンク
一般刊行物
- Tremellen K, Pearce K. Dysbiosis of Gut Microbiota (DOGMA)--a novel theory for the development of Polycystic Ovarian Syndrome. Med Hypotheses. 2012 Jul;79(1):104-12. doi: 10.1016/j.mehy.2012.04.016. Epub 2012 Apr 27.
- 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.
- Torres PJ, Ho BS, Arroyo P, Sau L, Chen A, Kelley ST, Thackray VG. Exposure to a Healthy Gut Microbiome Protects Against Reproductive and Metabolic Dysregulation in a PCOS Mouse Model. Endocrinology. 2019 May 1;160(5):1193-1204. doi: 10.1210/en.2019-00050.
- Liao B, Qiao J, Pang Y. Central Regulation of PCOS: Abnormal Neuronal-Reproductive-Metabolic Circuits in PCOS Pathophysiology. Front Endocrinol (Lausanne). 2021 May 28;12:667422. doi: 10.3389/fendo.2021.667422. eCollection 2021.
- Minabe S, Iwata K, Tsuchida H, Tsukamura H, Ozawa H. Effect of diet-induced obesity on kisspeptin-neurokinin B-dynorphin A neurons in the arcuate nucleus and luteinizing hormone secretion in sex hormone-primed male and female rats. Peptides. 2021 Aug;142:170546. doi: 10.1016/j.peptides.2021.170546. Epub 2021 Mar 29.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 646/23
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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 共有時間枠
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 共有アクセス基準
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 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。