Nutritional Supplements and Nitric Oxide Bioactivity

Vascular Function Clinical Trial

Official title:

The Effects of Nutritional Supplements on Postprandial Nitric Oxide Bioactivity in Abdominally Obese Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03625596
• Other study ID #: METC 18-3-010
• Status: Completed
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2020
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• L-Arginine
• Nitrate / Nitrite
• Nitric Oxide
• Postprandial Metabolism
• Vascular Function

Intervention

Dietary Supplement:
• L-Arginine
Acute intervention (3 hours)
• Nitrate / Nitrite
Acute intervention (3 hours)
• Placebo
Acute intervention (3 hours)

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Nutricia Research

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nitric oxide bioavailability	Flow-mediated vasodilation (FMD) of the brachial artery	Change from baseline at 2 hours after supplement intake
Secondary	Nitric oxide bioavailability	Plasma cyclic guanosine monophosphate (cGMP)	During 3 hours following supplement intake
Secondary	Vascular function markers	Retinal microvascular calibers	Change from baseline at 2 hours after supplement intake
Secondary	Cardiometabolic risk markers (1)	Plasma markers for low-grade systemic inflammation (CRP)	Change from baseline at 2 hours after supplement intake
Secondary	Cardiometabolic risk markers (2)	Plasma markers for endothelial dysfunction (NOx)	Change from baseline at 2 hours after supplement intake
Secondary	Cardiometabolic risk markers (3)	Office blood pressure	Change from baseline at 2 hours after supplement intake
Secondary	Postprandial metabolism (1)	Serum lipid metabolism	During 3 hours following supplement intake
Secondary	Postprandial metabolism (2)	Plasma glucose metabolism	During 3 hours following supplement intake