Dairy Products to Your Gut and Brain

NCT06311097 | Recruiting

• 1 other identifier: M402
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Constipation

Keywords

Diet; Fermented dairy; Gut-brain axis; Microbiota

Outcome Measures

Primary Outcomes (1)

• Difference in change from baseline in defecation frequency between the interventions

  Participants will report all bowel movements in a defecation diary in the week leading up to the intervention (baseline) and in the last week of the intervention (week 4)

  Baseline and 4 weeks

Secondary Outcomes (7)

• Difference in change from baseline in cognitive performance between the interventions

  Baseline and 4 weeks

• Difference in change from baseline in phase-amplitude coupling between gastric slow-wave activity and cortical alpha activity between the interventions

  Baseline and 4 weeks

• Difference in change from baseline in whole gut transit time between the interventions

  Baseline and 4 weeks

• Difference in change from baseline in stool consistency between the interventions

  Baseline and 4 weeks

• Difference in change from baseline in stool moisture between the interventions

  Baseline and 4 weeks

Other Outcomes (21)

• Difference in change from baseline in gut microbiota between the interventions

  Baseline and 4 weeks

• Difference in change from baseline in fecal pH between the interventions

  Baseline and 4 weeks

• Difference in change from baseline in breath hydrogen and methane levels between the interventions

  Baseline and 4 weeks

Study Arms (2)

Fermented dairy

EXPERIMENTAL

The fermented dairy product is Arla A38® naturel 1,5% yogurt. The yogurt contains Lactobacillus acidophilus culture.

Other: Fermented dairy

Non-fermented dairy

PLACEBO COMPARATOR

The non-fermented dairy product is Arla® Letmælk 1,5% (semi-skimmed milk). The fermented- and non-fermented dairy products are isocaloric and matched in macronutrient content.

Other: Non-fermented dairy

Interventions

Fermented dairy OTHER

Participants will consume 300g of yogurt daily for 4 weeks as an integral part of their habitual diet, substituting other food items.

Fermented dairy

Non-fermented dairy OTHER

Participants will consume 300g of milk daily for 4 weeks as an integral part of their habitual diet, substituting other food items.

Non-fermented dairy

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self-reported defecations every second day or less (intervention study only)
• Willing to consume 300g milk/yogurt on a daily basis (intervention study only)
• Owns a smartphone (iOS 11.0 and later or Android 5.0 and up)
• Understand Danish or English

You may not qualify if:

• Current pregnancy or lactation
• Dairy allergy or intolerance
• Prior diagnosis of psychiatric or neurological illness
• Current diagnosis of depression, anxiety, or stress
• Prior diagnosis of metabolic or gastrointestinal disease (e.g., cardiovascular disease, diabetes, chronic constipation or diarrhea, inflammatory bowel diseases (IBD), celiac disease, small intestinal bacterial overgrowth (SIBO), cancer, etc.)
• Use of antibiotics within the last month
• Use of peroral corticosteroids (inhalers excepted)
• Use of medications that alter normal bowel function and metabolism (e.g., laxatives, antidiarrheal agents, narcotics, diuretics, anticonvulsants, etc.)
• Use of neuroactive medications (e.g., antidepressants, anxiolytics, anticonvulsants, antipsychotics, antiparkinsonian, etc.)
• Concurrent participation in another trial
• Any condition that makes the project responsible researcher doubt the feasibility of the volunteer´s participation

Sponsors & Collaborators

• University of Copenhagen: lead
• University of Aarhus: collaborator
• APC Microbiome Ireland: collaborator

Study Sites (1)

University of Copenhagen, Department of Nutrition, Exercise and Sports

Copenhagen, Denmark

RECRUITING

MeSH Terms

Conditions

Constipation

Interventions

Cultured Milk Products

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Fermented Foods; Dairy Products; Food; Food and Beverages

Central Study Contacts

Henrik M Roager, PhD

CONTACT

+4535324928; hero@nexs.ku.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Two 4-week intervention periods separated by a washout period of at least 4 weeks. The crossover intervention will include 60 participants. Another 40 participants will only complete the first (baseline) visit.

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: March 15, 2024
• Study Start: April 8, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: April 15, 2024

Record last verified: 2024-04

Locations

DK (1)