Clinical trial

High-Dairy Food Patterns and Gut-Brain Axis

Opening soon · Not applicable · 1 countries · Registry ID NCT07355309

Opening soonNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age40 Years to 75 Years

SexAll

Healthy volunteersAccepted

ConditionBrain Insulin Sensitivity, Brain Vascular Function, Cerebral Blood Flow, Cognitive Performance, Appetite Control, Gut Microbiota

Full registry 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: * 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); * Willing to donate blood starting from 8 weeks before the study begins, throughout the study, and for 4 weeks after its inclusion; * Difficult to venipuncture as evidenced during the screening visit.

Treatments and study arms

High-dairy food pattern

Dietary Supplement

During the high-dairy period, participants will be instructed to consume 4-5 daily servings of dairy products, including: 1-2 servings of yogurt or cottage cheese (200 mL per serving, ≤1.5% fat), 1-2 servings of milk or buttermilk (250 mL per serving, ≤1.5% fat), and 1-2 servings of cheese (20 g per serving, 20+ or 30+ reduced-fat options).

Low-dairy food pattern

Dietary Supplement

During the low-dairy control period, participants will restrict dairy intake to a maximum of one serving per day

Primary outcomes

Brain Insulin SensitivityChange in brain insulin sensitivity (difference in CBF [mL/100 g tissue/min] before and after intranasal insulin) at the end of an 8-week high-dairy food pattern and an 8-week low-dairy food pattern

Cerebral blood flow measurements before and after a nasal insulin spray as quantified non-invasively by the MRI perfusion method Arterial Spin Labeling (ASL)

Brain vascular functionChange in brain vascular function (CBF in mL/100 g tissue/min) at the end of an 8-week high-dairy food pattern and an 8-week low-dairy food pattern

Cerebral blood flow as quantified non-invasively by the MRI perfusion method Arterial Spin Labeling (ASL)

Study locations

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Maastricht University🇳🇱 Maastricht, Limburg, Netherlands

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Kevin MR Nijssen, PhDContact

Email · Call +3143 3881305