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Effect of Polyphenols Combined to L-citrulline on Ambulatory Blood Pressure

NCT03679195 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2022-08-16

No results posted yet for this study

Summary

The general objective of this project is to investigate the chronic effect of consuming supplements combining polyphenols from cranberry and grape seed extracts and L-citrulline (Nitric Oxide Ultra capsules, Pure Encapsulations, Sudbury, MA) on 24-hour ambulatory blood pressure, markers of vascular function and plasma biomarkers of inflammation in adults with pre-hypertension.

The study will be undertaken according to a double-blind, parallel, randomized, placebo controlled design and will be conducted at the Institute of Nutrition and Functional Foods (INAF) of Laval University. The study will involve a total of 73 adult men and women. Included subjects will be randomly assigned to a 6-week period of supplementation with Nitric Oxide (NO) Ultra capsules or placebo (cellulose capsules). The outcomes are the chronic changes after supplementation with NO Ultra capsules compared with the placebo in: 24-hour ambulatory diastolic and systolic blood pressure, levels of blood lipids and inflammation markers, levels of blood and cutaneous markers of vascular function.

Conditions

Interventions

DIETARY_SUPPLEMENT

NO Ultra

6-week supplementation period with 764 mg/day of cranberry and grape seed extracts (containing polyphenols) and 2 g/day of L-citrulline Participants will have to take daily 2 NO Ultra capsules (containing 382 mg cranberry and grape seed extracts / 1 g L-citrulline) between breakfast and lunch and 2 other NO Ultra capsules between lunch and dinner.

DIETARY_SUPPLEMENT

Placebo

6-week supplementation period with placebo capsules (the active ingredients will be replaced by cellulose) Participants will have to take 2 capsules of cellulose between breakfast and lunch and 2 capsules between lunch and dinner to match the number of capsules ingested daily by the NO Ultra group.

Sponsors & Collaborators

  • Atrium Innovations

    collaborator INDUSTRY

  • Laval University

    lead OTHER

Principal Investigators

  • Benoît Lamarche, PhD · Laval University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-12
Primary Completion
2019-06-12
Completion
2021-01-15

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03679195 on ClinicalTrials.gov