NCT03679195

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 12, 2018

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 20, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2019

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2021

Completed
Last Updated

August 16, 2022

Status Verified

February 1, 2020

Enrollment Period

9 months

First QC Date

September 14, 2018

Last Update Submit

August 15, 2022

Conditions

Hypertension

Keywords

24h ambulatory blood pressure vascular function inflammation

Outcome Measures

Primary Outcomes (1)

  • 24-hour ambulatory diastolic blood pressure

    Comparison of the change from baseline in 24-hr ambulatory diastolic blood pressure at 6-wk between the NO Ultra group and the placebo group.

    6 weeks (end-point value)

Secondary Outcomes (4)

  • 24-hour ambulatory systolic blood pressure

    6 weeks (end-point value)

  • Blood Lipids

    6 weeks (end-point value)

  • Vascular function

    6 weeks (end-point value)

  • Inflammation biomarkers

    6 weeks (end-point value)

Study Arms (2)

NO Ultra (Nitric Oxid Ultra Capsules)

EXPERIMENTAL

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: NO Ultra

Placebo (Cellulose Capsules)

PLACEBO COMPARATOR

Participants will consume cellulose capsules that are similar in shape and size to the NO ultra product, i.e. 2 capsules between breakfast and lunch and 2 other capsules between lunch and dinner.

Dietary Supplement: Placebo

Interventions

NO UltraDIETARY_SUPPLEMENT

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.

NO Ultra (Nitric Oxid Ultra Capsules)
PlaceboDIETARY_SUPPLEMENT

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.

Also known as: Cellulose capsules
Placebo (Cellulose Capsules)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women aged between 18-75 years
  • For women with child-bearing potential, acceptable effective contraceptive methods are: total abstinence, hormonal birth control methods (oral, injectable, transdermal or intra-vaginal), intrauterine devices, confirmed successful vasectomy of partner
  • Stable weight for at least three 3 months (±5lbs)
  • Mean daytime SBP between 125 and 134.9 mmHg and DBP \< 85 mmHg
  • Otherwise healthy individuals

You may not qualify if:

  • Women during a peri-menopausal period
  • Pregnant/breastfeeding women
  • Mean daytime SBP \<125 or \>134.9 mmHg or DBP ≥85 mmHg
  • History of cardiovascular disease, type 2 diabetes, monogenic dyslipidemia or endocrine disorders
  • Use of anticoagulants or thrombocyte aggregation inhibitors, chemotherapeutic agents, anti-inflammatory drugs, medication for blood lipids, diabetes, hypertension, erectile dysfunction or auto-immune diseases
  • Any clinical signs or laboratory evidence for inflammatory, gastrointestinal, endocrine, renal, pulmonary, neurological, cardiovascular, metabolic, haematological problem or cancer
  • Kidney stones
  • Excess alcohol consumption (\> 14 consumptions/week) or drug consumption
  • Hypersensitivity/allergy to one of the ingredients (including non-medicinal ingredients) in NO Ultra supplement/placebo
  • Use of additional cranberry/grape seed extract or citrulline products

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Nutrition and Funtional Foods

Québec, G1V 0A6, Canada

Location

MeSH Terms

Conditions

Hypertension

Interventions

Cellulose

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

GlucansBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Benoît Lamarche, PhD

    Laval University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

September 14, 2018

First Posted

September 20, 2018

Study Start

September 12, 2018

Primary Completion

June 12, 2019

Study Completion

January 15, 2021

Last Updated

August 16, 2022

Record last verified: 2020-02

Locations

CA(1)