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.
None
use of medications affecting carbohydrate or lipid metabolism, or medications influencing body weight, within the previous 3 months (assessed during a medical interview conducted by the recruiting gynecologist);
use of antibiotics, probiotics, and/or prebiotics within the previous 3 months;
smoking within the previous 3 months or alcohol consumption >100 g/week;
participation in competitive sports;
Parallel
Time-restricted eating
BehavioralTime-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 3 months (12 weeks).
Change in composition of the intestinal microbiota
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.
Change in lipopolysaccharide concentration in blood
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).
Change in Short Chain Fatty Acids concentration in stool
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.
Change in energy consumption
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.
Change in body composition
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)
Change in glucose metabolism - glucose concentration
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).
Change in glucose metabolism - insulin concentration
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).
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Joanna Bajerska
Lead sponsor
Poznan University of Life Sciences
Sponsor institution
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