Skip to main content
OpenTrials
Completed

NCT Number: NCT03625596

Nutritional Supplements and Nitric Oxide Bioactivity

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

40 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Center

Maastricht, Limburg, 6229 ER, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

L-Arginine

Dietary Supplement

Acute intervention (3 hours)

Nitrate / Nitrite

Dietary Supplement

Acute intervention (3 hours)

Placebo

Dietary Supplement

Acute intervention (3 hours)

Primary outcomes

  1. Nitric oxide bioavailability

    Time frame: Change from baseline at 2 hours after supplement intake

    Flow-mediated vasodilation (FMD) of the brachial artery

Secondary outcomes

  1. Nitric oxide bioavailability

    Time frame: During 3 hours following supplement intake

    Plasma cyclic guanosine monophosphate (cGMP)

  2. Vascular function markers

    Time frame: Change from baseline at 2 hours after supplement intake

    Retinal microvascular calibers

  3. Cardiometabolic risk markers (1)

    Time frame: Change from baseline at 2 hours after supplement intake

    Plasma markers for low-grade systemic inflammation (CRP)

  4. Cardiometabolic risk markers (2)

    Time frame: Change from baseline at 2 hours after supplement intake

    Plasma markers for endothelial dysfunction (NOx)

  5. Cardiometabolic risk markers (3)

    Time frame: Change from baseline at 2 hours after supplement intake

    Office blood pressure

  6. Postprandial metabolism (1)

    Time frame: During 3 hours following supplement intake

    Serum lipid metabolism

  7. Postprandial metabolism (2)

    Time frame: During 3 hours following supplement intake

    Plasma glucose metabolism

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Nutricia Research

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 10, 2018
Registry last updated
Feb 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.