Effects of Time-Restricted Feeding Pattern (16:8) on Metabolic Variables and Appetite Related Gastrointestinal Hormones in Women With Polycystic Ovary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 45
- 主要终点
- Changes in body mass index (BMI)
研究概览
简要总结
This study aims to evaluate the effects of a 16:8 time-restricted feeding (TRF) model on anthropometric, metabolic, and hormonal parameters in women with polycystic ovary syndrome (PCOS). In addition, the study will assess participants' food preferences, nutrient intake, and gastrointestinal hormone responses, alongside serum glucose, insulin, and glucagon levels, during ad libitum breakfast meals served at the beginning and end of the intervention.
The study consists of three groups: women with PCOS following a 16:8 TRF model for 12 weeks, women with PCOS following an energy-restricted diet for 12 weeks, and healthy women following a 16:8 TRF model for 12 weeks. Women aged 18-40, with PCOS based on the Rotterdam criteria, will be included in the PCOS groups, while those without PCOS-related symptoms will form the control group. Exclusion criteria include pregnancy, lactation, use of hormonal medications, and the presence of comorbidities such as diabetes or severe liver/kidney dysfunction.
Participants in the TRF groups will consume their daily caloric intake within an 8-hour eating window, fasting for the remaining 16 hours, while the energy-restricted group will follow a balanced diet without timing restrictions. Adherence to the dietary interventions will be monitored through weekly 24-hour dietary records. At baseline, participants will complete a demographic questionnaire, receive nutritional education for their nutritional plan, and undergo assessments for anthropometric and blood pressure measurements, sleep quality, food cravings, and physical activity. Biochemical analyses will evaluate thyroid and sex hormones, electrolytes, liver enzymes, lipid profiles, and hemograms. Additionally, all participants will wear smart wristbands (FitBit Charge 5) throughout the study to track sleep and physical activity.
At the beginning and end of the study, participants will consume a standardized ad libitum breakfast meal during the early follicular phase (days 2-5 of menstrual bleeding). Participants will have 30 minutes to eat as much as they wish, and their consumption will be recorded by a dietitian. The nutrient content of the consumed foods will be analyzed using the Nutrition Information System (BEBIS) software. Blood samples will be collected and visual analogue scala (VAS) will be filled at fasting and at 30, 60, 90, and 120 minutes post-meal. Serum glucose, insulin, glucagon, ghrelin, and incretin hormones will be analyzed using the enzyme-linked immunosorbent analysis (ELISA) method.
Data analysis will be performed using SPSS 23.0 via appropriate statistically analysis. Statistical significance is set at p<0.05.
详细描述
This study aims to investigate the effects of the 16:8 time-restricted feeding (TRF) model on anthropometric, hormonal, metabolic variables, and dietary habits in women with polycystic ovary syndrome (PCOS). The research will evaluate food cravings, food preferences, energy, and macro-micronutrient intake, as well as postprandial responses of glucose, insulin, glucagon and gastrointestinal hormones involved in appetite regulation (ghrelin, glucagon-like peptide (GLP)-1, and gastric inhibitory peptide (GIP)) in women with PCOS. The findings will be compared to a group of women with PCOS following an energy-restricted diet model and a control group of healthy women adhering to the 16:8 time-restricted feeding model.
The study will include adult women who were newly diagnosed with PCOS according to the Rotterdam criteria (presence of at least two of the following: (I) oligo- or anovulation, (II) clinical or biochemical hyperandrogenism, and (III) polycystic ovary morphology on ultrasound) or who had previously been diagnosed with PCOS but had not undergone any medical or nutritional therapy. Participants will be recruited from the Endocrinology and Metabolism Clinic of Hacettepe University Faculty of Medicine, Department of Internal Medicine. For the control group, volunteers with no chronic diseases will be recruited via posters announcing the study.
The study will include the following groups:
(I) Women with PCOS following time-restricted feeding model (16:8) for 12 weeks (II) Women with PCOS following an energy-restricted diet for 12 weeks (III) Healthy women following time-restricted feeding model (16:8) for 12 weeks Due to the lack of similar studies in the literature, an initial sample size of 15 participants per group will be recruited. Interim analysis will be conducted once 15 participants per group are reached. It is expected that participants will lose 5% of their initial body weight after the 12-week dietary intervention, and the interim analysis will be evaluated based on this parameter. If the achieved statistical power is 80% or higher, the study will be concluded; however, if it falls below 80%, the number of additional participants required to reach 80% power will be determined.
For PCOS groups, women aged 19-35 years with body mass index (BMI) 25-40 kg/m2 who meet the diagnostic criteria for PCOS based on the Rotterdam criteria, will be eligible for participation. Further, participants between the ages of 19-35 with BMI 25-40 kg/m2 who do not meet any PCOS diagnostic criteria after endocrinological and gynecological examinations will be included as the control group. For both PCOS groups and control groups, pregnancy, lactation, presence of chronic diseases such as hypertension, diabetes mellitus, cardiovascular diseases, etc., use of hormonal medications, or the presence of comorbidities such as type 2 diabetes mellitus or severe liver/kidney dysfunction will excluded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •For study groups of women diagnosed with polycystic ovary syndrome (PCOS)
- •Aged between 19 and 35 years, with a diagnosis of PCOS
- •No chronic diseases diagnosed by a physician, other than PCOS
- •Body mass index (BMI) between 25 and 40 kg/m²
- •No use of oral contraceptives, insulin sensitizers, or anti-androgen medications in the last three months
- •For the healthy control group
- •Aged between 19 and 35 years
- •No diagnosis of chronic diseases
- •Body mass index (BMI) between 25 and 40 kg/m²
- •No use of oral contraceptives, insulin sensitizers, or anti-androgen medications in the last three months
排除标准
- •For all study groups:
- •Being in the menopause, pregnancy, or lactation period
- •Having a diagnosis of any chronic disease (e.g., hypertension, diabetes mellitus, cardiovascular disease, etc.) other than PCOS, as determined by a physician
- •Having hyperprolactinemia, congenital adrenal hyperplasia, androgen-secreting tumors, thyroid disorders, Cushing's syndrome, hepatic or renal dysfunction
- •Using antihyperlipidemic, antihypertensive, or glucocorticoid medications
- •Following any specific dietary treatment
研究组 & 干预措施
PCOS+ER
Women with PCOS following energy-restricted diet for 12 weeks
干预措施: Dietary Intervention (energy restricted dietary intervention) (Other)
PCOS+TRF
Women with PCOS following time-restricted feeding model (16:8) for 12 weeks
干预措施: Dietary Intervention (time-restricted feeding model (16:8)) (Other)
Control+TRF
Healthy women following time-restricted feeding model (16:8) for 12 weeks
干预措施: Dietary Intervention (time-restricted feeding model (16:8)) (Other)
结局指标
主要结局
Changes in body mass index (BMI)
时间窗: Beginning of the experiment (week 0), 2nd, 4th, 6th, 8th, 10th study weeks and end of the experiment for each participants (week 12).
BMI will be calculated using weight (kg) and height (m²). Weight and height will be measured separately and used to derive BMI as a single reported outcome.
Changes in serum fasting glucose and lipit profile
时间窗: Beginning of the experiment (week 0) and end of the experiment for each participants (12th study week)
Changes in fasting glucose, triglycerides, total cholesterol, low density lipoprotein-cholesterol, and high density lipoprotein-cholesterol (HDL-C) levels will be measured via enzymatic biochemical analysis. All values will be reported in millimolar (mM) and analyzed collectively as metabolic biomarkers.
Changes in appetite-related hormones (insulin, glucagon, ghrelin, glucagon-like peptid-1, and gastric inhibitory peptide)
时间窗: At both the beginning (week 0) and completion of the experiment for each participant (12th study week) , measurements were taken at the start of the open buffet breakfast and subsequently at the 30th, 60th, 90th, and 120th minutes.
Changes in insulin, glucagon, ghrelin, glucagon-like peptide-1, and gastric inhibitory peptide levels will be measured via enzyme-linked immunosorbent assay (ELISA kits). All values will be reported in nanomolar (nM) and analyzed collectively as appetite-regulating hormones.
次要结局
- Food craving(Beginning (week 0), week 2, 4, 6, 8, 10, and end of the study (week 12))
- Sleep quality(Beginning (week 0), week 2, 4, 6, 8, 10, and end of the study (week 12))
- Physical activity(Beginning (week 0), week 2, 4, 6, 8, 10, and end of the study (week 12))
- Change in daily energy intake(0-12 weeks)
- Blood pressure(Beginning (week 0), week 2, 4, 6, 8, 10, and end of the study (week 12))
- Visual analogue scale score(At both the beginning (week 0) and completion of the experiment for each participant (12th study week) , measurements were taken at the start of the open buffet breakfast and subsequently at the 30th, 60th, 90th, and 120th minutes.)
研究者
Aylin Acikgoz Pinar
Associated Proffessor Doctor
Hacettepe University