Nutritional Supplements and Nitric Oxide Bioactivity

NCT03625596 | Completed

• 1 other identifier: METC 18-3-010
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Nitric oxide bioavailability

  Flow-mediated vasodilation (FMD) of the brachial artery

  Change from baseline at 2 hours after supplement intake

Secondary Outcomes (7)

• Nitric oxide bioavailability

  During 3 hours following supplement intake

• Vascular function markers

  Change from baseline at 2 hours after supplement intake

• Cardiometabolic risk markers (1)

  Change from baseline at 2 hours after supplement intake

• Cardiometabolic risk markers (2)

  Change from baseline at 2 hours after supplement intake

• Cardiometabolic risk markers (3)

  Change from baseline at 2 hours after supplement intake

Study Arms (5)

High L-arginine

ACTIVE COMPARATOR

During this experimental day, men will receive a high-fat shake with a high dose of L-arginine.

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.

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.

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.

Dietary Supplement: Nitrate / Nitrite

Placebo

PLACEBO COMPARATOR

During this experimental day, men will receive a high-fat shake without supplement.

Dietary Supplement: Placebo

Interventions

L-Arginine DIETARY_SUPPLEMENT

Acute intervention (3 hours)

High L-arginine; Low L-arginine + Nitrate / Nitrite; Medium L-arginine + Nitrate / Nitrite

Nitrate / Nitrite DIETARY_SUPPLEMENT

Acute intervention (3 hours)

Low L-arginine + Nitrate / Nitrite; Medium L-arginine + Nitrate / Nitrite; Nitrate / Nitrite

Placebo DIETARY_SUPPLEMENT

Acute intervention (3 hours)

Placebo

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Nutricia Research: collaborator

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6229 ER, Netherlands

Location

MeSH Terms

Interventions

Arginine; Nitrates; Nitrites

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential; Anions; Ions; Electrolytes; Inorganic Chemicals; Nitric Acid; Nitrogen Compounds; Organic Chemicals; Nitrous Acid

Study Officials

• Peter J Joris, PhD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Crossover assignment

Study Record Dates

• First Submitted: July 24, 2018
• First Posted: August 10, 2018
• Study Start: December 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: February 20, 2020

Record last verified: 2020-02

Locations

NL (1)