Dairy Products to Your Gut and Brain

University of Copenhagen96 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Healthy Constipation

Interventions

Fermented dairyOTHER

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

Non-fermented dairyOTHER

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

Eligibility

Sex: FEMALEMin age: 45 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Locations (1)

University of Copenhagen, Department of Nutrition, Exercise and Sports

Copenhagen, Denmark

Outcomes

Primary Outcomes

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)

Time frame: Baseline and 4 weeks

Secondary Outcomes

Difference in change from baseline in cognitive performance between the interventions

Changes in cognitive performance will be quantified by cognitive index comprising memory, attention, and psychomotor speed. A composite cognitive score will be calculated as the standard score. Z-score will be assessed with the baseline variance between 0 and 1. Memory: number of errors made by the participant. Lower number of errors indicating better outcome. Attention: latency (speed of response), probability of false alarms and sensitivity. Faster speed of response indicating better outcome and lower number of false alarms indicating better outcome. Psychomotor speed: lower values indicating faster reaction time and better outcome

Time frame: 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

Gastric and cortical electrical activity will be measured by electrogastrography (EGG) and electroencephalography (EEG), respectively, to investigate the phase-amplitude coupling between the infra-slow (\~ 0.05 Hz) gastric phase and the amplitude of the cortical alpha rhythm (10-11 Hz)

Time frame: Baseline and 4 weeks

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

Whole gut transit time will be estimated by sweet-corn passage time

Time frame: Baseline and 4 weeks

Difference in change from baseline in stool consistency between the interventions

Data from ClinicalTrials.gov

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