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High-Dairy Food Pattern and Gut-Brain Axis

Longer-term effects of a high-dairy food pattern on the gut-brain axis in adults with overweight or obesity - High-dairy food patterns and gut-brain axis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON58185
Enrollment
80
Registered
2025-08-05
Start date
2025-12-19
Completion date
Unknown
Last updated
2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome, Syndrome X, Insulin Resistance Syndrome Metabool Syndrome

Interventions

Participants will follow either a high-dairy food pattern (4–5 daily servings of dairy products) or a low-dairy food pattern (=1 serving daily), in randomized order. Each intervention will last 8 week

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Men and postmenopausal women (= 2 years since last menstruation);Aged between 40-75 years;BMI between 25-35 kg/m2 (overweight or obese);Low-to-moderate habitual dairy consumption (= 3 servings/day);Fasting serum total cholesterol < 8.0 mmol/L;Fasting serum triacylglycerol < 4.5 mmol/L;Fasting plasma glucose < 7.0 mmol/L;Systolic blood pressure < 160 mmHg and diastolic blood pressure < 100 mmHg;Stable body weight (weight gain or loss < 3 kg in the past three months).

Exclusion criteria

Exclusion criteria: Left-handedness;Milk protein allergy or lactose intolerance; Current smoker, or smoking cessation < 12 months;Familial hypercholesterolemia;Abuse of drugs;Alcoholic intake >3 standard drinks/day;Use of medications, food products or dietary supplements affecting glucose, lipid, or blood pressure regulation, gut microbiota or mental or neurological function, judged by the principal investigator;Use of antibiotics within the previous month;Use of other biomedical investigational products within the previous month;Participation in another clinical trial within the past month;Severe medical conditions including type 2 diabetes, epilepsy, asthma, kidney failure, COPD, inflammatory bowel disease, autoimmune diseases, or rheumatoid arthritis;History of cardiovascular events (e.g., heart attack, stroke) or active cardiovascular disease;Contra-indications for MRI imaging (e.g. pacemaker, metal implants, claustrophobia);Willingness to not donate blood starting from 8 weeks before the study begins, throughout the study, and for 4 weeks after its inclusion;No difficult venipuncture as evidenced during the screening visit.

Design outcomes

Primary

MeasureTime frame
The primary endpoint is effect of a high-dairy food pattern as compared with a low-dairy food pattern on (regional) brain vascular function and insulin-sensitivity, as assessed by the gray-matter CBF response to intranasally administered insulin using MRI ASL. 

Secondary

MeasureTime frame
Secondary objectives include changes in cognitive performance (via the CANTAB neuropsychological test battery), gut microbiota composition (via shotgun metagenomic analysis of fecal samples), and appetite-related brain reward activity (via BOLD-fMRI with food cues). 

Countries

Netherlands

Contacts

Public ContactKMR Nijssen

Universiteit Maastricht

k.nijssen@maastrichtuniversity.nl0433881305

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Mar 20, 2026