Nitrate and Brain Insulin-Sensitivity (NCT04700241) | Clinical Trial Compass
CompletedNot Applicable
Nitrate and Brain Insulin-Sensitivity
Netherlands18 participantsStarted 2021-01-21
Plain-language summary
Disturbances in brain insulin-sensitivity are not only observed in abdominal obesity and type 2 diabetes mellitus (T2D), but also during brain aging and in dementia. Inorganic nitrate may improve brain insulin-sensitivity, which can be quantified by measuring the gray-matter cerebral blood flow (CBF) response to intranasally administered insulin, through beneficial effects on brain vascular function. Therefore, we now hypothesize that inorganic nitrate, which can be found in several vegetables such as beetroot, improves brain insulin-sensitivity, as assessed by the gray-matter CBF response to intranasally administered insulin, in abdominally obese men.
Who can participate
Age range
18 Years – 60 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Men;
* Aged between 18 - 60 years;
* Waist circumference \> 102 cm (abdominally obese);
* Fasting plasma glucose ≤ 7.0 mmol/L;
* Fasting serum total cholesterol ≤ 8.0 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);
* 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;
* Willingness not to use antibacterial mouth wash or toothpaste, chewing-gum and tongue-scraping a week before the study;
* No difficult venipuncture as evidenced during the screening visit.
Exclusion Criteria:
* Women;
* Left-handedness;
* Current smoker, or smoking cessation \< 12 months;
* Diabetic patients;
* Familial hypercholesterolemia;
* 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;
* Pharmacological treatment advised based on the Dutch general practitioners' association (NHG) for cardiovascular risk management;
* 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 obst…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Brain insulin sensitivity
Timeframe: Change from placebo intervention at 2 hours after supplement intake