Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06311097
Status:
RECRUITING
Last Update Posted:
2024-04-15
First Post:
2024-03-07
Brief Title:
Dairy Products to Your Gut and Brain
Sponsor:
University of Copenhagen
Organization:
University of Copenhagen
Study Overview
Official Title:
Dairy Products to Your Gut and Brain
Status:
RECRUITING
Status Verified Date:
2024-04
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:
YourGutBrain
Brief Summary:
The goal of this intervention study is to compare the effects of fermented dairy and non-fermented dairy on bowel habits and cognitive performance in healthy women with defecations every other day or less Furthermore the study aims to explore underlying mechanisms linking the gut and the brain
In addition a sub-study will be conducted to explore differences in gut and brain measures between women with daily reference group and few intervention group weekly bowel movements respectively and to explore associations between measures of gut- and brain function
In addition a sub-study will be conducted to explore differences in gut and brain measures between women with daily reference group and few intervention group weekly bowel movements respectively and to explore associations between measures of gut- and brain function
Detailed Description:
Participants in the intervention study n60 will consume 300g of fermented dairy yogurt or non-fermented dairy milk daily for 4 weeks After a washout period of at least 4 weeks the participants will consume the alternative dairy product yogurt or milk for 4 weeks The participants will collect samples at home and be tested at the institute before and after each condition yogurt or milk
Participants in the sub-study n40 will not undergo any dairy interventions and they will only take part in the baseline assessments
Prior to all visits at the institute the participants are asked to complete some study activities at home including
consumption of sweet corns to estimate whole gut transit time
collection of fecal- and urine samples
measurement of methane and hydrogen in breath
reporting of gastrointestinal symptoms including stool frequency and Bristol Stool Scale
During all visits at the institute the participants will undergo tests and measurements including
measurement of methane and hydrogen in fasting breath
collection of fasting blood samples
completion of cognitive tests
recordings of electrophysiological signals of the gut and the brain
completion of questionnaires assessing mood quality of life and physical activity among others
Participants in the sub-study n40 will not undergo any dairy interventions and they will only take part in the baseline assessments
Prior to all visits at the institute the participants are asked to complete some study activities at home including
consumption of sweet corns to estimate whole gut transit time
collection of fecal- and urine samples
measurement of methane and hydrogen in breath
reporting of gastrointestinal symptoms including stool frequency and Bristol Stool Scale
During all visits at the institute the participants will undergo tests and measurements including
measurement of methane and hydrogen in fasting breath
collection of fasting blood samples
completion of cognitive tests
recordings of electrophysiological signals of the gut and the brain
completion of questionnaires assessing mood quality of life and physical activity among others
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