Clinical trial NCT03625596: Nutritional Supplements and Nitric Oxide Bioactivity
Official title: The Effects of Nutritional Supplements on Postprandial Nitric Oxide Bioactivity in Abdominally Obese Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nitric Oxide
Vascular Function
L-Arginine
Nitrate / Nitrite
Postprandial Metabolism
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Nutricia Research
First posted: 2018-08-10
Enrollment: 20
Sex: MALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover assignment
Primary purpose: PREVENTION

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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)
* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Nitric oxide bioavailability
timeFrame: Change from baseline at 2 hours after supplement intake
Secondary outcomes:
measure: Nitric oxide bioavailability
timeFrame: During 3 hours following supplement intake
measure: Vascular function markers
timeFrame: Change from baseline at 2 hours after supplement intake
measure: Cardiometabolic risk markers (1)
timeFrame: Change from baseline at 2 hours after supplement intake
measure: Cardiometabolic risk markers (2)
timeFrame: Change from baseline at 2 hours after supplement intake
measure: Cardiometabolic risk markers (3)
timeFrame: Change from baseline at 2 hours after supplement intake
measure: Postprandial metabolism (1)
timeFrame: During 3 hours following supplement intake
measure: Postprandial metabolism (2)
timeFrame: During 3 hours following supplement intake
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: Peter J Joris, PhD
role: PRINCIPAL_INVESTIGATOR
References: