Nitric OxideNCT03625596
Nutritional Supplements and Nitric Oxide Bioactivity
A study testing L-Arginine and Nitrate / Nitrite in people with Nitric Oxide and Vascular Function, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Obese people have a disturbed postprandial metabolism and thereby a decreased postprandial vascular function. Nitric oxide plays an important role in the postprandial vascular function. Read more about this study
- Who is it for?
- Ages 40 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Nitric Oxide, Vascular Function, L-Arginine
- What is being tested?
- L-Arginine and Nitrate / Nitrite
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Dec 2018to 31 Dec 2019
- 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 40 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men
- Aged between 40-70 years
- Waist circumference ≥ 102
- Fasting plasma glucose < 7.0 mmol/L
- Fasting serum total cholesterol < 8.0 mmol/L
- Stable body weight (weight gain or loss < 3 kg in the past three months)
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- 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
- No current smoker
- No diabetic patients
- No familial hypercholesterolemia
- No abuse of drugs
- No more than 3 alcoholic consumptions per day
- No use of medication known to treat blood pressure, lipid or glucose metabolism
- No use of an investigational product within another biomedical intervention trial within the previous 1-month
- No 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
- No active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebrovascular accident
- Willingness to give up the use of antibacterial mouth wash or antibacterial toothpaste, chewing-gum and tongue- scraping on the morning of each experimental test day
Who cannot join
- Women
- Fasting plasma glucose ≥ 7.0 mmol/L
- Fasting serum total cholesterol ≥ 8.0 mmol/L
- 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
- Unstable body weight (weight gain or loss > 3 kg in the past three months)
- Use medication known 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
- Not willing to give up being a blood donor from 8 weeks before the start of the study, during the study or for 4 weeks after completion of the study
- Not or difficult to venipuncture as evidenced during the screening visit
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center
Maastricht, Limburg, 6229 ER
About this study
Official title: The Effects of Nutritional Supplements on Postprandial Nitric Oxide Bioactivity in Abdominally Obese Men
Obese people have a disturbed postprandial metabolism and thereby a decreased postprandial vascular function. Nitric oxide plays an important role in the postprandial vascular function. Multiple studies already focused on various nutritional compounds to improve the postprandial vascular function by increasing the nitric oxide bioactivity. However, the vast majority of the trials has been performed with relatively high doses of the individual components, which are problematic to convert into daily food measures, thereby preventing translation of these findings. Well-designed trails studying the effect of feasible amounts of nutritional supplements on the bioactivity of nitric oxide and vascular function are missing.
- Being tested
- L-Arginine, Nitrate / Nitrite, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-ArginineDietary supplement
Acute intervention (3 hours)
Nitrate / NitriteDietary supplement
Acute intervention (3 hours)
PlaceboDietary supplement
Acute intervention (3 hours)
| Study group | Role | What they receive |
|---|---|---|
| High L-arginine | Active comparator | During this experimental day, men will receive a high-fat shake with a high dose of L-arginine. Receives: Dietary Supplement: L-Arginine |
| Medium L-arginine + Nitrate / Nitrite | Experimental | During this experimental day, men will receive a high-fat shake with a medium dose of L-arginine enriched with nitrate and nitrite. Receives: Dietary Supplement: L-Arginine; Dietary Supplement: Nitrate / Nitrite |
| Low L-arginine + Nitrate / Nitrite | Experimental | During this experimental day, men will receive a high-fat shake with a low dose of L-arginine enriched with nitrate and nitrite. Receives: Dietary Supplement: L-Arginine; Dietary Supplement: Nitrate / Nitrite |
| Nitrate / Nitrite | Experimental | During this experimental day, men will receive a high-fat shake with nitrate and nitrite. Receives: Dietary Supplement: Nitrate / Nitrite |
| Placebo | Placebo comparator | During this experimental day, men will receive a high-fat shake without supplement. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nitric oxide bioavailability
Flow-mediated vasodilation (FMD) of the brachial artery
Measured: Change from baseline at 2 hours after supplement intake
Secondary outcomes (7)
Nitric oxide bioavailability
Plasma cyclic guanosine monophosphate (cGMP)
Measured: During 3 hours following supplement intake
Vascular function markers
Retinal microvascular calibers
Measured: Change from baseline at 2 hours after supplement intake
Cardiometabolic risk markers (1)
Plasma markers for low-grade systemic inflammation (CRP)
Measured: Change from baseline at 2 hours after supplement intake
Cardiometabolic risk markers (2)
Plasma markers for endothelial dysfunction (NOx)
Measured: Change from baseline at 2 hours after supplement intake
Cardiometabolic risk markers (3)
Office blood pressure
Measured: Change from baseline at 2 hours after supplement intake
Postprandial metabolism (1)
Serum lipid metabolism
Measured: During 3 hours following supplement intake
Postprandial metabolism (2)
Plasma glucose metabolism
Measured: During 3 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.
- First posted10 Aug 2018
- Study start1 Dec 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nitric OxideStudies 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
- Crossover assignment
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Nutricia Research
- Responsible party
- Sponsor
- Investigators
- Peter J Joris, PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03625596
- Sponsor's protocol ID
- METC 18-3-010
- Status last verified
- Feb 2020
- First submitted
- 24 Jul 2018
- Last updated
- 20 Feb 2020
- 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 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Nutritional Supplements on Postprandial Nitric Oxide Bioactivity in Abdominally Obese Men
- ClinicalTrials.gov ID
- NCT03625596
- Acronym / sponsor ID
- METC 18-3-010
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Nutricia Research
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 10 Aug 2018 (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.
Obese people have a disturbed postprandial metabolism and thereby a decreased postprandial vascular function. Nitric oxide plays an important role in the postprandial vascular function. Multiple studies already focused on various nutritional compounds to improve the postprandial vascular function by increasing the nitric oxide bioactivity. However, the vast majority of the trials has been performed with relatively high doses of the individual components, which are problematic to convert into daily food measures, thereby preventing translation of these findings. Well-designed trails studying the effect of feasible amounts of nutritional supplements on the bioactivity of nitric oxide and vascular function are missing.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- Crossover assignment
| Arm | Type | Receives |
|---|---|---|
| High L-arginine | Active comparator | Dietary Supplement: L-ArginineDuring this experimental day, men will receive a high-fat shake with a high dose of L-arginine. |
| Medium L-arginine + Nitrate / Nitrite | Experimental | Dietary Supplement: L-Arginine, Dietary Supplement: Nitrate / NitriteDuring this experimental day, men will receive a high-fat shake with a medium dose of L-arginine enriched with nitrate and nitrite. |
| Low L-arginine + Nitrate / Nitrite | Experimental | Dietary Supplement: L-Arginine, Dietary Supplement: Nitrate / NitriteDuring this experimental day, men will receive a high-fat shake with a low dose of L-arginine enriched with nitrate and nitrite. |
| Nitrate / Nitrite | Experimental | Dietary Supplement: Nitrate / NitriteDuring this experimental day, men will receive a high-fat shake with nitrate and nitrite. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboDuring this experimental day, men will receive a high-fat shake without supplement. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Men
- Aged between 40-70 years
- Waist circumference ≥ 102
- Fasting plasma glucose < 7.0 mmol/L
- Fasting serum total cholesterol < 8.0 mmol/L
Key exclusion criteria (15 listed)
- Women
- Fasting plasma glucose ≥ 7.0 mmol/L
- Fasting serum total cholesterol ≥ 8.0 mmol/L
- 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 |
|---|---|---|
| L-ArginineAcute intervention (3 hours) | Dietary supplement | High L-arginine, Low L-arginine + Nitrate / Nitrite, Medium L-arginine + Nitrate / Nitrite |
| Nitrate / NitriteAcute intervention (3 hours) | Dietary supplement | Low L-arginine + Nitrate / Nitrite, Medium L-arginine + Nitrate / Nitrite, Nitrate / Nitrite |
| PlaceboAcute intervention (3 hours) | Dietary supplement | Placebo |
Primary outcome
Nitric oxide bioavailability
Time frame: Change from baseline at 2 hours after supplement intake
Flow-mediated vasodilation (FMD) of the brachial artery
7 secondary outcomes
Nitric oxide bioavailability
Time frame: During 3 hours following supplement intake
Vascular function markers
Time frame: Change from baseline at 2 hours after supplement intake
Cardiometabolic risk markers (1)
Time frame: Change from baseline at 2 hours after supplement intake
Cardiometabolic risk markers (2)
Time frame: Change from baseline at 2 hours after supplement intake
Cardiometabolic risk markers (3)
Time frame: Change from baseline at 2 hours after supplement intake
Postprandial metabolism (1)
Time frame: During 3 hours following supplement intake
Postprandial metabolism (2)
Time frame: During 3 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 20 Feb 2020.
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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. This study is not recruiting at the moment.
Peter J Joris, PhD principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L-Arginine and Nitrate / Nitrite in people with Nitric Oxide and 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 18 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: finished, as of the sponsor's last update on 20 Feb 2020. 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?
Nitric oxide bioavailability (time frame: Change from baseline 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?
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 20 Feb 2020.