NitrateNO-BRAINSNCT04700241

Nitrate and Brain Insulin-Sensitivity

A study testing Potassium nitrate in people with Nitrate and Brain Insulin-sensitivity, run by Maastricht University Medical Center at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 60 years, men onlyHealthy volunteers can take part
Conditions the study is for: Nitrate, Brain Insulin-sensitivity, Vascular Function
What is being tested?: Potassium nitrate
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 18 participants
Where: 1 siteNetherlands
Study dates: 21 Jan 2021to 5 May 2021
Phase: Interventional
Are there results?: None posted in the registry

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 18 to 60 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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;

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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;
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.

Who cannot join

Women;
Left-handedness;
Current smoker, or smoking cessation < 12 months;
Diabetic patients;
Familial hypercholesterolemia;
Abuse of drugs;

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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 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;
Specific contra-indications for MRI imaging, including pacemakers, surgical clips/material in body, metal splinters in eye, claustrophobia, or tattoos in the facial area, such as permanent make-up.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

Maastricht University Medical Center
Maastricht, Limburg, 6229 ER

Other trials in Netherlands

About this study

Official title: Acute Effects of Inorganic Nitrate on Brain Insulin-sensitivity in Abdominally Obese Men

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.

Conditions: Nitrate, Brain Insulin-sensitivity, Vascular Function
Being tested: Potassium nitrate, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Potassium nitrateDietary supplement
Acute intervention (5.5 hours)
PlaceboDietary supplement
Acute intervention (5.5 hours)

Study groups in NCT04700241
Study group	Role	What they receive
Potassium nitrate	Active comparator	During this experimental day, men will receive 10 mmol of potassium nitrate Receives: Dietary Supplement: Potassium nitrate
Placebo	Placebo comparator	During this experimental day, men will receive an isomolar dose of potassium chloride Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Brain insulin sensitivity
MRI arterial spin labeling, cerebral blood flow measurements before and after a nasal insulin spray
Measured: Change from placebo intervention at 2 hours after supplement intake

Secondary outcomes (9)

Brain vascular function
MRI arterial spin labeling, cerebral blood flow measurements
Measured: Change from placebo intervention at 2 hours after supplement intake
Vascular function markers
Flow-mediated vasodilation (FMD) of the brachial and femoral artery
Measured: Change from fasting at 4 hours after supplement intake
Cold pressure test
Carotid artery response to cold pressure test
Measured: Change from placebo at 4 hours after supplement intake
Cardiometabolic risk markers (1)
Plasma markers for low-grade systemic inflammation (CRP)
Measured: Change from placebo at 4 hours after supplement intake
Cardiometabolic risk markers (2)
Plasma marker for endothelial dysfunction (NOx)
Measured: Change from placebo at 4 hours after supplement intake
Cardiometabolic risk markers (3)
Office blood pressure
Measured: Change from placebo at 4 hours after supplement intake
Cardiometabolic risk markers (4)
Plasma brain derived neurotrophic factor (BDNF)
Measured: During the 5.5 hours following supplement intake
Postprandial metabolism (1)
Serum lipid metabolism
Measured: During the 5.5 hours following supplement intake
Postprandial metabolism (2)
Plasma glucose metabolism
Measured: During the 5.5 hours following supplement intake

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Jan 20215 May 2021

First posted7 Jan 2021
Study start21 Jan 2021
Primary completion5 May 2021
Study completion5 May 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for NitrateStudies 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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04700241
Sponsor's protocol ID: METC 20-0.78
Acronym: NO-BRAINS
Status last verified: Apr 2021
First submitted: 6 Jan 2021
Last updated: 9 Jun 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Kleinloog JPD, Mensink RP, Smeets ETHC, Ivanov D, Joris PJ. Acute inorganic nitrate intake increases regional insulin action in the brain: Results of a double-blind, randomized, controlled cross-over trial with abdominally obese men. Neuroimage Clin. 2022;35:103115. doi: 10.1016/j.nicl.2022.103115. Epub 2022 Jul 14.
PubMed 35843050

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Exercise Training Intensity and Nitrate Supplementation in Post-Menopausal Females on Hormone Therapy
Postmenopausal Female Patients, Vasomotor Symptoms
Not yet recruiting
Post-exercise Blood Pressure With Inorganic Nitrate
Obese Individuals, Central Adiposity
RecruitingPhase 4
Preoperative Coadministration of Low-concentration Carbohydrate and Nitrates Loading vs Low- Concentration Carbohydrate Loading Alone in Patients Undergoing Open Gynecological Surgeries
Length of Hospital Stay
Enrolling by invitation
Beetroot Juice and Neuromuscular Performance in Female Basketball Players
Nitrate, Placebo - Control
Not yet recruiting
Effectiveness of Silver Nitrate Cauterization vs Conservative Management in Tympanic Membrane Perforation Closure
Tympanic Membrane Perforation

All Nitrate trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Acute Effects of Inorganic Nitrate on Brain Insulin-sensitivity in Abdominally Obese Men
ClinicalTrials.gov ID: NCT04700241
Acronym / sponsor ID: NO-BRAINS / METC 20-0.78
Conditions: Nitrate, Brain Insulin-sensitivity, Vascular Function
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Maastricht University Medical CenterUniversity, hospital or other
Study start: 21 Jan 2021 (actual)
Primary completion: 5 May 2021 (actual)
Study completion: 5 May 2021 (actual)
First posted: 7 Jan 2021 (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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Potassium nitrate	Active comparator	Dietary Supplement: Potassium nitrateDuring this experimental day, men will receive 10 mmol of potassium nitrate
Placebo	Placebo comparator	Dietary Supplement: PlaceboDuring this experimental day, men will receive an isomolar dose of potassium chloride

Who may qualify

Ages: 18 to 60 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 listed)

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;

Key exclusion criteria (14 listed)

Women;
Left-handedness;
Current smoker, or smoking cessation < 12 months;
Diabetic patients;
Familial hypercholesterolemia;

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
Potassium nitrateAcute intervention (5.5 hours)	Dietary supplement	Potassium nitrate
PlaceboAcute intervention (5.5 hours)	Dietary supplement	Placebo

Primary outcome

Brain insulin sensitivity
Time frame: Change from placebo intervention at 2 hours after supplement intake
MRI arterial spin labeling, cerebral blood flow measurements before and after a nasal insulin spray

9 secondary outcomes

Brain vascular function
Time frame: Change from placebo intervention at 2 hours after supplement intake
Vascular function markers
Time frame: Change from fasting at 4 hours after supplement intake
Cold pressure test
Time frame: Change from placebo at 4 hours after supplement intake
Cardiometabolic risk markers (1)
Time frame: Change from placebo at 4 hours after supplement intake
Cardiometabolic risk markers (2)
Time frame: Change from placebo at 4 hours after supplement intake
Cardiometabolic risk markers (3)
Time frame: Change from placebo at 4 hours after supplement intake
Cardiometabolic risk markers (4)
Time frame: During the 5.5 hours following supplement intake
Postprandial metabolism (1)
Time frame: During the 5.5 hours following supplement intake
Postprandial metabolism (2)
Time frame: During the 5.5 hours following supplement intake

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
Derived from this study: PubMed 35843050Kleinloog JPD, Mensink RP, Smeets ETHC, Ivanov D, Joris PJ. Acute inorganic nitrate intake increases regional insulin action in the brain: Results of a double-blind, randomized, controlled cross-over trial with abdominally obese men. Neuroimage Clin. 2022;35:103115. doi: 10.1016/j.nicl.2022.103115. Epub 2022 Jul 14.
Individual participant dataSharing planned: No

Related trials for Nitrate

Not yet recruiting
Exercise Training Intensity and Nitrate Supplementation in Post-Menopausal Females on Hormone Therapy
Postmenopausal Female Patients, Vasomotor Symptoms
Not yet recruiting
Post-exercise Blood Pressure With Inorganic Nitrate
Obese Individuals, Central Adiposity
RecruitingPhase 4
Preoperative Coadministration of Low-concentration Carbohydrate and Nitrates Loading vs Low- Concentration Carbohydrate Loading Alone in Patients Undergoing Open Gynecological Surgeries
Length of Hospital Stay
Enrolling by invitation
Beetroot Juice and Neuromuscular Performance in Female Basketball Players
Nitrate, Placebo - Control
Not yet recruiting
Effectiveness of Silver Nitrate Cauterization vs Conservative Management in Tympanic Membrane Perforation Closure
Tympanic Membrane Perforation

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. This study is not recruiting at the moment.

Peter J. Joris, Dr principal investigator

Maastricht University

Ronald P.M. Mensink, Dr 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 Potassium nitrate in people with Nitrate and Brain Insulin-sensitivity, 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 10 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: finished, as of the sponsor's last update on 9 Jun 2021. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Brain insulin sensitivity (time frame: Change from placebo intervention at 2 hours after supplement intake). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04700241, which also lists 1 linked publication.

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 Jun 2021.