Ignite Creation Date:
2024-05-06 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06204965
Status:
RECRUITING
Last Update Posted:
2024-01-17
First Post:
2024-01-03
Brief Title:
The Impact of Time-restricted Eating on the Outcomes Associated With Polycystic Ovary Syndrome
Sponsor:
Joanna Bajerska
Organization:
Poznan University of Life Sciences
Study Overview
Official Title:
The Impact of Time-restricted Eating on the Composition of the Intestinal Microbiota and Metabolic and Neurohormonal Parameters of Women With Polycystic Ovary Syndrome
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Polycystic Ovary Syndrome PCOS is a disorder that affects approximately 10-15 of women of reproductive age Increased activity of the hypothalamic-pituitary-ovarian HPO axis is considered to be one of the main factors associated with the pathogenesis of PCOS The regulation of the activity of this axis is influenced by the following factors insulin resistance and the activity of kisspeptins in the hypothalamus It is suggested that intestinal dysbiosis may also play a key role in the pathogenesis of PCOS It was noticed that the presence of bacteria producing gamma-aminobutyric acid in the intestine is positively correlated with the concentration of luteinizing hormone LH in the serum which indicates the relationship between the functioning of the gut-brain axis and PCOS A dysbiotic factor is an incorrect diet and inappropriate timing of its consumption which may also lead to inhibition of kisspeptin expression in the hypothalamus and cause menstrual disorders
Due to the fact that most obese women with PCOS eat significantly more meals in the second part of the day and these meals are characterized by a significant supply of fat and simple sugars intestinal dysbiosis seems to be an important cause of the observed disorders while the use of chrononutrition consisting in synchronizing meal times with endogenous 24-hour circadian rhythms may partially restore eubiosis in the intestine and improve the reproductive metabolic and neurohormonal health of women with PCOS Time-restricted feeding TRF which involves eating food usually within 8 hours followed by 16 hours of fasting seems to be a regime that allows restoring eubiosis in the intestinal microbiota and improving the quality of life of women with PCOS So far only one study has been conducted among women with PCOS who used TRF for 5 weeks and a number of positive changes were demonstrated hormonal or metabolic However this study did not include an assessment of the microbial and neurohormonal parameters which seems to be a key issue
Taking the above into account it was hypothesized that TRF may be an appropriate therapeutic tool for women with PCOS which will positively affect metabolic and hormonal parameters by changing the composition of the intestinal microbiota Therefore the main aim of the experiment is to investigate the impact of TRF on the composition of the intestinal microbiota its metabolites and metabolic and neurohormonal parameters in women with PCOS
Due to the fact that most obese women with PCOS eat significantly more meals in the second part of the day and these meals are characterized by a significant supply of fat and simple sugars intestinal dysbiosis seems to be an important cause of the observed disorders while the use of chrononutrition consisting in synchronizing meal times with endogenous 24-hour circadian rhythms may partially restore eubiosis in the intestine and improve the reproductive metabolic and neurohormonal health of women with PCOS Time-restricted feeding TRF which involves eating food usually within 8 hours followed by 16 hours of fasting seems to be a regime that allows restoring eubiosis in the intestinal microbiota and improving the quality of life of women with PCOS So far only one study has been conducted among women with PCOS who used TRF for 5 weeks and a number of positive changes were demonstrated hormonal or metabolic However this study did not include an assessment of the microbial and neurohormonal parameters which seems to be a key issue
Taking the above into account it was hypothesized that TRF may be an appropriate therapeutic tool for women with PCOS which will positively affect metabolic and hormonal parameters by changing the composition of the intestinal microbiota Therefore the main aim of the experiment is to investigate the impact of TRF on the composition of the intestinal microbiota its metabolites and metabolic and neurohormonal parameters in women with PCOS
Detailed Description:
Fifty two women aged 18-40 will be recruited for the study The investigators calculated the sample size using GPower software RRIDSCR_013726 the sample size of the participants was also determined The effect size was calculated to be 104 on the basis of the differences in body fat mass between baseline values and values after 6-weeks of application of time-restricted eating by PCOS women With an alpha value of 005 a sample size of eight mice per group would yield a power of 095
Women recruited for the study will be provided with detailed information regarding the purpose of the study the study protocol the measurements performed and the duration of the study Recruitment will take place via social networking sites ie Facebook where target groups will be found bringing together women with PCOS and posts with an announcement and a contact form will be placed there After obtaining consent to participate in the study a group of qualified women will undergo a general medical interview by Jakub Noskiewicz PhD which will include a personal interview including current medications and supplements taken medical history and a basic physical examination - examination percussion If the interview reveals an existing infection a chronic disease in the acute phase a suspicion of eg anemia infectious skin diseases or malnutrition or the intake of medications constituting an exclusion criterion the patient will not be qualified for the study During this interview participants will be asked to provide medical documentation confirming they suffer from PCOS
Participants will be randomly assigned using a specialized program to two groups - control and intervention Research participants assigned to the control group will receive dietary recommendations consistent with the healthy eating plate Additionally the recommended daily energy intake will be individually determined for each patient Participants assigned to the TRF group will be instructed to continue eating their usual diet during the experiment without any qualitative or quantitative restrictions but to eat it within a limited time frame - from 900 am to 500 pm and then fast until the next day protocol 816 The duration of the study will be 3 months 12 weeks
A nutritional assessment of the diet will be carried out KomPAN questionnaire The nutritional assessment will be additionally supplemented by an interview from the last 24 hours Then the recruited women will be randomly assigned to the intervention group using time-restricted nutrition or the control group using the principles of the healthy eating plate The duration of the experiment will be 12 weeks with follow-up visits scheduled at 4-week intervals At the beginning of the experiment and at follow-up visits women will have blood drawn per 18 ml to assess biochemical parameters Each time a stool sample will also be collected to assess the composition of the intestinal microbiota and short-chain fatty acids and an analysis of body composition bone density and anthropometric parameters will be carried out During the last visit in week 12 women will be asked to fill out the KomPAN questionnaire again which will be supplemented by an interview from the last 24 hours Each time an interview will be conducted regarding the womens well-being and adherence to the recommendations provided The level of adherence to the eating window will be verified using a diary in which women will write down each day when they ate their first and last meals
The following specific analyses are planned
Assessment of anthropometric parameters body weight height waist circumference hip circumference as well as body composition and bone density
Assessment of carbohydrate metabolism parameters concentration of glucose insulin calculation of HOMA-IR HOMA-β QUICKI lipid metabolism concentration of total cholesterol T-C LDL cholesterol LDL-C HDL cholesterol HDL-C non-HDL cholesterol non-HDL-C and triglycerides
Assessment of hormonal parameters FSH LH testosterone SHBG and lipopolysaccharide in the blood
Assessment of neurohormonal parameters kisspeptin gamma-aminobutyric acid in the blood
Assessment of the composition of intestinal microbiota and short-chain fatty acids in womens feces
Normality of the obtained data distribution will be tested using the Shapiro-Wilk test The Kruskal-Wallis test then will be used for nonnormally distributed data and the Tukey HSD test will be used for normally distributed data A p value of less than 005 was considered statistically The microbiota composition will be analyzed using RStudio R version 403 2020-10-10 with packages including phyloseq microbiome and vegan Taxa will be filtered by removing all those not assigned to any phylum Only taxa with abundances over 025 in at least one sample will left in the dataset All analyses of gut microbiota composition will be performed on the basis of the relative abundances RA of the OTUs
The data collected in the planned studies will include the results of measurements and their statistical analyzes All data will be collected directly by team members and coded Detailed instructions on data collection will be prepared by the team leader and each member will need to read and receive appropriate training All biochemical and anthropometric measurements will be performed in at least two repetitions and will be checked by another team member All used specialized equipment will be properly calibrated before each use scale body composition analyzer Nanodrop spectrophotometer
Women recruited for the study will be provided with detailed information regarding the purpose of the study the study protocol the measurements performed and the duration of the study Recruitment will take place via social networking sites ie Facebook where target groups will be found bringing together women with PCOS and posts with an announcement and a contact form will be placed there After obtaining consent to participate in the study a group of qualified women will undergo a general medical interview by Jakub Noskiewicz PhD which will include a personal interview including current medications and supplements taken medical history and a basic physical examination - examination percussion If the interview reveals an existing infection a chronic disease in the acute phase a suspicion of eg anemia infectious skin diseases or malnutrition or the intake of medications constituting an exclusion criterion the patient will not be qualified for the study During this interview participants will be asked to provide medical documentation confirming they suffer from PCOS
Participants will be randomly assigned using a specialized program to two groups - control and intervention Research participants assigned to the control group will receive dietary recommendations consistent with the healthy eating plate Additionally the recommended daily energy intake will be individually determined for each patient Participants assigned to the TRF group will be instructed to continue eating their usual diet during the experiment without any qualitative or quantitative restrictions but to eat it within a limited time frame - from 900 am to 500 pm and then fast until the next day protocol 816 The duration of the study will be 3 months 12 weeks
A nutritional assessment of the diet will be carried out KomPAN questionnaire The nutritional assessment will be additionally supplemented by an interview from the last 24 hours Then the recruited women will be randomly assigned to the intervention group using time-restricted nutrition or the control group using the principles of the healthy eating plate The duration of the experiment will be 12 weeks with follow-up visits scheduled at 4-week intervals At the beginning of the experiment and at follow-up visits women will have blood drawn per 18 ml to assess biochemical parameters Each time a stool sample will also be collected to assess the composition of the intestinal microbiota and short-chain fatty acids and an analysis of body composition bone density and anthropometric parameters will be carried out During the last visit in week 12 women will be asked to fill out the KomPAN questionnaire again which will be supplemented by an interview from the last 24 hours Each time an interview will be conducted regarding the womens well-being and adherence to the recommendations provided The level of adherence to the eating window will be verified using a diary in which women will write down each day when they ate their first and last meals
The following specific analyses are planned
Assessment of anthropometric parameters body weight height waist circumference hip circumference as well as body composition and bone density
Assessment of carbohydrate metabolism parameters concentration of glucose insulin calculation of HOMA-IR HOMA-β QUICKI lipid metabolism concentration of total cholesterol T-C LDL cholesterol LDL-C HDL cholesterol HDL-C non-HDL cholesterol non-HDL-C and triglycerides
Assessment of hormonal parameters FSH LH testosterone SHBG and lipopolysaccharide in the blood
Assessment of neurohormonal parameters kisspeptin gamma-aminobutyric acid in the blood
Assessment of the composition of intestinal microbiota and short-chain fatty acids in womens feces
Normality of the obtained data distribution will be tested using the Shapiro-Wilk test The Kruskal-Wallis test then will be used for nonnormally distributed data and the Tukey HSD test will be used for normally distributed data A p value of less than 005 was considered statistically The microbiota composition will be analyzed using RStudio R version 403 2020-10-10 with packages including phyloseq microbiome and vegan Taxa will be filtered by removing all those not assigned to any phylum Only taxa with abundances over 025 in at least one sample will left in the dataset All analyses of gut microbiota composition will be performed on the basis of the relative abundances RA of the OTUs
The data collected in the planned studies will include the results of measurements and their statistical analyzes All data will be collected directly by team members and coded Detailed instructions on data collection will be prepared by the team leader and each member will need to read and receive appropriate training All biochemical and anthropometric measurements will be performed in at least two repetitions and will be checked by another team member All used specialized equipment will be properly calibrated before each use scale body composition analyzer Nanodrop spectrophotometer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None