NCT06311097

Dairy Products to Your Gut and Brain

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Copenhagen · Academic / Other
• Sex: Female
• Age: 45 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

Participants in the intervention study (n=60) 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 (n=40) 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

Conditions

• Healthy
• Constipation

Interventions

Type	Name	Description
OTHER	Fermented dairy	Participants will consume 300g of yogurt daily for 4 weeks as an integral part of their habitual diet, substituting other food items.
OTHER	Non-fermented dairy	Participants will consume 300g of milk daily for 4 weeks as an integral part of their habitual diet, substituting other food items.

Timeline

• Start date: 2024-04-08
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2024-03-15
• Last updated: 2024-04-15

Locations

1 site across 1 country: Denmark