Brain Vascular FunctionNCT07057245
Effects of Protein Supplementation on Brain Function
A study testing Protein supplementation with an animal-based protein isolate and Protein supplementation with a plant-based protein isolate in people with Brain Vascular Function and Cognitive Function, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Protein-rich foods may improve brain insulin-sensitivity, which is important for cognitive and metabolic health, and may also translate into an improved food intake regulation. It is therefore pertinent to delineate the effects of plant-derived proteins, which are a more sustainable alternative to animal-derived… Read more about this study
- Who is it for?
- Ages 60 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Vascular Function, Cognitive Function, Satiety
- What is being tested?
- Protein supplementation with an animal-based protein isolate and Protein supplementation with a plant-based protein isolate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteNetherlands
- Study dates
- 2 Jul 2025to 31 Dec 2025
- 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 60 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women, aged between 60-75 years (older adults)
- BMI between 25-35 kg/m2 (overweight or obese)
- Fasting plasma glucose < 7.0 mmol/L
- Fasting serum total cholesterol < 8.0 mmol/L
- Fasting serum triacylglycerol < 4.5 mmol/L
- Systolic blood pressure < 160 mmHg and diastolic blood pressure < 100 mmHg
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- Stable body weight (weight gain or loss < 3 kg in the past three months)
- Willingness to give up being a blood donor from 8 weeks before the start of the study, during the study and for 4 weeks after completion of the study
- No difficult venipuncture as evidenced during the screening visit
Who cannot join
- Intolerant to milk products or fava bean allergy
- Vegetarians
- Left-handedness
- Current smoker, or smoking cessation < 12 months
- Diabetic patients
- Familial hypercholesterolemia
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- Abuse of drugs
- More than 3 alcoholic consumptions per day
- Use of products or dietary supplements known to interfere with the main outcomes as judged by the principal investigators
- Use medication to treat blood pressure, lipid, or glucose metabolism
- Use of an investigational product within another biomedical intervention trial within the previous 1-month
- Severe medical conditions that might interfere with the study, such as epilepsy, asthma, kidney failure or renal insufficiency, chronic obstructive pulmonary disease, inflammatory bowel diseases, auto inflammatory diseases, and rheumatoid arthritis
- Active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebrovascular accident
- Contra-indications for MRI imaging (e.g., pacemaker, surgical clips/material in body, metal splinter in eye, claustrophobia)
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, 1 recruiting
- Recruiting
Maastricht University Medical Center
Maastricht, Limburg, 6229ER
Peter Joris, PhD, +31-88-3887250, p.joris@maastrichtuniversity.nl
Lucia Kerkhof, MSc, +31-88-3887280, l.kerkhof@maastrichtuniversity.nl
About this study
Official title: Effects of Daily Protein Supplementation on Brain Function in Older Adults With Overweight or Obesity
Protein-rich foods may improve brain insulin-sensitivity, which is important for cognitive and metabolic health, and may also translate into an improved food intake regulation. It is therefore pertinent to delineate the effects of plant-derived proteins, which are a more sustainable alternative to animal-derived proteins, on brain insulin-sensitivity and related functional benefits. The hypothesis is that daily plant-derived or animal-derived protein supplementation improves brain vascular function and insulin-sensitivity, thereby improving cognitive performance and appetite control in overweight or obese older men and women.
The primary objective is to investigate in overweight or obese older adults the effect of daily protein supplementation for two weeks with either a plant-derived protein or an animal-derived protein on vascular function and insulin-sensitivity in the brain, while changes in cognitive performance and appetite-related brain reward activity will also be evaluated (secondary study objectives). Cerebral blood flow responses before (brain vascular function) and after the administration of intranasal insulin spray (brain insulin-sensitivity) will be quantified by the gold standard magnetic resonance imaging (MRI)-perfusion method Arterial Spin Labeling (ASL).
- Conditions
- Brain Vascular Function, Cognitive Function, Satiety, Cerebral Blood Flow, Brain Insulin Sensitivity
- Being tested
- Protein supplementation with an animal-based protein isolate, Protein supplementation with a plant-based protein isolate, Control arm - cornstarch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein supplementation with an animal-based protein isolateDietary supplement
Study participants will consume, in random order, twice daily (2 x ~20 g) a plant protein (fava bean protein isolate), animal protein (milk protein isolate) or control (cornstarch providing no extra protein)
Protein supplementation with a plant-based protein isolateDietary supplement
Study participants will consume, in random order, twice daily (2 x ~20 g) a plant protein (fava bean protein isolate), animal protein (milk protein isolate) or control (cornstarch providing no extra protein)
Control arm - cornstarchOther
Study participants will consume, in random order, twice daily (2 x ~20 g) a plant protein (fava bean protein isolate), animal protein (milk protein isolate) or control (cornstarch providing no extra protein)
| Study group | Role | What they receive |
|---|---|---|
| Plant-based protein | Experimental | Not described Receives: Dietary Supplement: Protein supplementation with a plant-based protein isolate |
| Animal-based protein | Experimental | Not described Receives: Dietary Supplement: Protein supplementation with an animal-based protein isolate |
| Control arm | Other | Cornstarch providing no extra protein Receives: Other: Control arm - cornstarch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral blood flow responses before (brain vascular function) and after the administration of intranasal insulin spray (brain insulin-sensitivity)
Measured: Measured after 2 weeks of supplementation with protein isolate or control
Secondary outcomes (2)
Cognitive performance
Cognitive performance will be assessed with a neuropsychological test battery
Measured: Measured after 2 weeks of supplementation with protein isolate or control
Appetite-related brain reward activity
Blood oxygenation level-dependent (BOLD)-functional MRI (fMRI) response to food cues
Measured: Measured after 2 weeks of supplementation with protein isolate or control
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start2 Jul 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Vascular FunctionStudies 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Cosun
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07057245
- Sponsor's protocol ID
- METC 24-053
- Status last verified
- May 2025
- First submitted
- 2 May 2025
- Last updated
- 9 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Daily Protein Supplementation on Brain Function in Older Adults With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT07057245
- Acronym / sponsor ID
- METC 24-053
- Conditions
- Brain Vascular Function, Cognitive Function, Satiety, Cerebral Blood Flow, Brain Insulin Sensitivity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Cosun
- Study start
- 2 Jul 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 9 Jul 2025 (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.
Protein-rich foods may improve brain insulin-sensitivity, which is important for cognitive and metabolic health, and may also translate into an improved food intake regulation. It is therefore pertinent to delineate the effects of plant-derived proteins, which are a more sustainable alternative to animal-derived proteins, on brain insulin-sensitivity and related functional benefits. The hypothesis is that daily plant-derived or animal-derived protein supplementation improves brain vascular function and insulin-sensitivity, thereby improving cognitive performance and appetite control in overweight or obese older men and women.
The primary objective is to investigate in overweight or obese older adults the effect of daily protein supplementation for two weeks with either a plant-derived protein or an animal-derived protein on vascular function and insulin-sensitivity in the brain, while changes in cognitive performance and appetite-related brain reward activity will also be evaluated (secondary study objectives). Cerebral blood flow responses before (brain vascular function) and after the administration of intranasal insulin spray (brain insulin-sensitivity) will be quantified by the gold standard magnetic resonance imaging (MRI)-perfusion method Arterial Spin Labeling (ASL).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Plant-based protein | Experimental | Dietary Supplement: Protein supplementation with a plant-based protein isolate |
| Animal-based protein | Experimental | Dietary Supplement: Protein supplementation with an animal-based protein isolate |
| Control arm | Other | Other: Control arm - cornstarchCornstarch providing no extra protein |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Men and women, aged between 60-75 years (older adults)
- BMI between 25-35 kg/m2 (overweight or obese)
- Fasting plasma glucose < 7.0 mmol/L
- Fasting serum total cholesterol < 8.0 mmol/L
- Fasting serum triacylglycerol < 4.5 mmol/L
Key exclusion criteria (14 listed)
- Intolerant to milk products or fava bean allergy
- Vegetarians
- Left-handedness
- Current smoker, or smoking cessation < 12 months
- Diabetic patients
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 |
|---|---|---|
| Protein supplementation with an animal-based protein isolateStudy participants will consume, in random order, twice daily (2 x ~20 g) a plant protein (fava bean protein isolate), animal protein (milk protein isolate) or control (cornstarch providing no extra protein) | Dietary supplement | Animal-based protein |
| Protein supplementation with a plant-based protein isolateStudy participants will consume, in random order, twice daily (2 x ~20 g) a plant protein (fava bean protein isolate), animal protein (milk protein isolate) or control (cornstarch providing no extra protein) | Dietary supplement | Plant-based protein |
| Control arm - cornstarchStudy participants will consume, in random order, twice daily (2 x ~20 g) a plant protein (fava bean protein isolate), animal protein (milk protein isolate) or control (cornstarch providing no extra protein) | Other | Control arm |
Primary outcome
Cerebral blood flow responses before (brain vascular function) and after the administration of intranasal insulin spray (brain insulin-sensitivity)
Time frame: Measured after 2 weeks of supplementation with protein isolate or control
2 secondary outcomes
Cognitive performance
Time frame: Measured after 2 weeks of supplementation with protein isolate or control
Appetite-related brain reward activity
Time frame: Measured after 2 weeks of supplementation with protein isolate or control
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 9 Jul 2025.
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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.
Maastricht University Medical Center
Maastricht, Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein supplementation with an animal-based protein isolate and Protein supplementation with a plant-based protein isolate in people with Brain Vascular Function and Cognitive 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 14 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: looking for participants now, as of the sponsor's last update on 9 Jul 2025. 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. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral blood flow responses before (brain vascular function) and after the administration of intranasal insulin spray (brain insulin-sensitivity) (time frame: Measured after 2 weeks of supplementation with protein isolate or control). 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 9 Jul 2025.