NCT07355309Not yet recruiting
High-Dairy Food Patterns and Gut-Brain Axis
Longer-term Effects of High-dairy Food Patterns on the Gut-brain Axis in Adults With Overweight or Obesity
Source: ClinicalTrials.gov · Last updated 21 Jan 2026
Brief summary (registry, in English)
Disturbances in brain insulin sensitivity are associated not only with obesity and type 2 diabetes, but also with brain aging and cognitive decline. Longitudinal studies suggest that dietary patterns, particularly those high in dairy intake, may impact brain function via the gut-brain axis. Indeed, dairy foods are known to modulate gut microbiota and may, through this pathway, not only improve brain insulin sensitivity and cognitive performance, but also mental health and appetite regulation. However, underlying mechanisms remain largely unexplored. The primary objective of this study is to evaluate, in older adults with overweight or obesity, the effects of a high-dairy food pattern (4-5 daily servings of (butter)milk, cheese, yogurt, or cottage cheese) compared to a low-dairy food pattern (≤1 serving daily) on (regional) brain vascular function and insulin sensitivity. These outcomes will be quantified using the non-invasive MRI perfusion technique Arterial Spin Labeling (ASL), which assesses cerebral blood flow (CBF) in response to intranasal insulin, a validated physiological marker of brain insulin sensitivity. 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). Exploratory analyses include conventional cardiometabolic risk markers (blood pressure, lipid and glucose metabolism), and perceivable (consumer) benefits.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 10 Dec 2025
- Start date
- 22 Dec 2025
- Primary completion date
- 1 Apr 2027
- Lead sponsor
- Maastricht University Medical Center
- Diseases
- Obesity
- NCT number
- NCT07355309
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 22 Dec 2025 to the primary completion date, 1 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Abuse of drugs;
- Use of antibiotics within the previous month;
- Use of other biomedical investigational products within the previous month;
- Contra-indications for MRI imaging (e.g. pacemaker, metal implants, claustrophobia);
- Willing to donate blood starting from 8 weeks before the study begins, throughout the study, and for 4 weeks after its inclusion;
Other illness
- Milk protein allergy or lactose intolerance;
- 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;
Lab values
- 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;
Other
- Left-handedness;
- Current smoker, or smoking cessation \< 12 months;
- Familial hypercholesterolemia;
- Alcoholic intake \>3 standard drinks/day;
- Participation in another clinical trial within the past month;
- Difficult to venipuncture as evidenced during the screening visit.
Who the study is looking for
- 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).
Age in the registry: 40 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Maastricht University Coordinator of this site? Confirm its status | Maastricht | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.