Brain Insulin SensitivityNCT07355309
High-Dairy Food Patterns and Gut-Brain Axis
A study testing High-dairy food pattern and Low-dairy food pattern in people with Brain Insulin Sensitivity and Brain Vascular Function, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Insulin Sensitivity, Brain Vascular Function, Cerebral Blood Flow
- What is being tested?
- High-dairy food pattern and Low-dairy food pattern
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- 22 Dec 2025to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
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- 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).
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site
Maastricht University
Maastricht, Limburg, 6229ER
Kevin MR Nijssen, PhD, +3143 3881305, k.nijssen@maastrichtuniversity.nl
About this study
Official title: Longer-term Effects of High-dairy Food Patterns on the Gut-brain Axis in Adults With Overweight or Obesity
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.
- Conditions
- Brain Insulin Sensitivity, Brain Vascular Function, Cerebral Blood Flow, Cognitive Performance, Appetite Control, Gut Microbiota
- Being tested
- High-dairy food pattern, Low-dairy food pattern
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-dairy food patternDietary 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 patternDietary supplement
During the low-dairy control period, participants will restrict dairy intake to a maximum of one serving per day
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | High-Dairy Food Pattern Receives: Dietary Supplement: High-dairy food pattern |
| Control | Placebo comparator | Low-Dairy Food Pattern Receives: Dietary Supplement: Low-dairy food pattern |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain Insulin Sensitivity
Cerebral blood flow measurements before and after a nasal insulin spray as quantified non-invasively by the MRI perfusion method Arterial Spin Labeling (ASL)
Measured: Change 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
Brain vascular function
Cerebral blood flow as quantified non-invasively by the MRI perfusion method Arterial Spin Labeling (ASL)
Measured: Change 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
Secondary outcomes (3)
Cognitive Performance
Cambridge Neuropsychological Test Automated Battery (CANTAB)
Measured: Change in cognitive performance (test-specific standardized scores) at the end of an 8-week high-dairy food pattern and an 8-week low-dairy food pattern
Gut microbial composition
Shotgun metagenomics of fecal samples
Measured: Change in gut microbial composition (shannon index indicating α-diversity) using gene relative abundance profiles at the start and end of an 8-week high-dairy food pattern and an 8-week low-dairy food pattern
Appetite-related brain reward activity
Appetite-related brain reward activity will be assessed by blood oxygenation level-dependent (BOLD) functional MRI responses to standardized food cues
Measured: Change in appetite-related brain reward activity (functional connectivity [BOLD signal changes]) at the end of an 8-week high-dairy food pattern and an 8-week low-dairy food pattern
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start22 Dec 2025 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Insulin SensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study is a randomized, controlled, crossover intervention trial. Each participant will complete two 8-week intervention periods (high-dairy and low-dairy food patterns) separated by a washout period of at least 8 weeks, resulting in a total study duration of approximately 24 weeks.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Dairy Council
- Responsible party
- Sponsor
- Investigators
- Ronald P Mensink, PhD, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07355309
- Sponsor's protocol ID
- METC25-043
- Status last verified
- Jan 2026
- First submitted
- 10 Dec 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longer-term Effects of High-dairy Food Patterns on the Gut-brain Axis in Adults With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT07355309
- Acronym / sponsor ID
- METC25-043
- Conditions
- Brain Insulin Sensitivity, Brain Vascular Function, Cerebral Blood Flow, Cognitive Performance, Appetite Control, Gut Microbiota
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- National Dairy Council
- Study start
- 22 Dec 2025 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a randomized, controlled, crossover intervention trial. Each participant will complete two 8-week intervention periods (high-dairy and low-dairy food patterns) separated by a washout period of at least 8 weeks, resulting in a total study duration of approximately 24 weeks.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Dietary Supplement: High-dairy food patternHigh-Dairy Food Pattern |
| Control | Placebo comparator | Dietary Supplement: Low-dairy food patternLow-Dairy Food Pattern |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (15 listed)
- Left-handedness;
- Milk protein allergy or lactose intolerance;
- Current smoker, or smoking cessation < 12 months;
- Familial hypercholesterolemia;
- Abuse of drugs;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-dairy food patternDuring 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). | Dietary supplement | Experimental |
| Low-dairy food patternDuring the low-dairy control period, participants will restrict dairy intake to a maximum of one serving per day | Dietary supplement | Control |
Primary outcome
Brain Insulin Sensitivity
Time frame: Change 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 function
Time frame: Change 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)
3 secondary outcomes
Cognitive Performance
Time frame: Change in cognitive performance (test-specific standardized scores) at the end of an 8-week high-dairy food pattern and an 8-week low-dairy food pattern
Gut microbial composition
Time frame: Change in gut microbial composition (shannon index indicating α-diversity) using gene relative abundance profiles at the start and end of an 8-week high-dairy food pattern and an 8-week low-dairy food pattern
Appetite-related brain reward activity
Time frame: Change in appetite-related brain reward activity (functional connectivity [BOLD signal changes]) at the end of an 8-week high-dairy food pattern and an 8-week low-dairy food pattern
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ronald P Mensink, PhD principal investigator
Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-dairy food pattern and Low-dairy food pattern in people with Brain Insulin Sensitivity and Brain Vascular Function, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kevin MR Nijssen, PhD (+31433881305, k.nijssen@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain Insulin Sensitivity (time frame: Change 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.