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

NCT ID: NCT03679195

Last Updated: 2022-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-12
• Study Completion Date: 2021-01-15

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.

Detailed Description

There is now evidence that blood pressure, vascular function and inflammation are intimately associated with cardiovascular disease. It is also clear that several dietary components including polyphenols and L-citrulline can modify blood pressure control. However, based on the studies available so far, it is difficult to draw firm conclusion on the potential impact of a dietary supplement combining polyphenols and L-citrulline on ambulatory blood pressure in pre-hypertensive subjects at risk to develop hypertension and cardiovascular disease. To the best of our knowledge, no study has yet investigated the chronic impact of combined polyphenols and L-citrulline on both ambulatory blood pressure and vascular function/inflammation.

The present supplementation based on polyphenols and L-citrulline may represent for pre-hypertensive subjects a new dietary modality to manage blood pressure as part of healthy eating.

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. A total of 73 adult men and women will be recruited based primarily on blood pressure criteria in the Quebec City metropolitan area. Participants will be randomly assigned to a 6-week period of supplementation with Nitric Oxide Ultra capsules or placebo (cellulose capsules). Participants in the NO Ultra group will be supplemented 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 capsules (NO Ultra or placebo) between breakfast and lunch and 2 capsules (NO Ultra or placebo) between lunch and dinner. Specifically, capsules will be taken with water and no foods, and at least one-hour apart meals. Office and 24-hour ambulatory blood pressure, blood lipids, cutaneous and plasma markers of vascular function, plasma inflammation biomarkers and anthropometric characteristics will be measured at the beginning and at the end of the study.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

NO Ultra (Nitric Oxid Ultra Capsules)

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.

Group Type: EXPERIMENTAL

NO Ultra

Intervention Type: DIETARY_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.

Placebo (Cellulose Capsules)

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Cellulose capsules

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Atrium Innovations

INDUSTRY

Sponsor Role: collaborator

Laval University

OTHER

Sponsor Role: lead

Responsible Party

Benoit Lamarche

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Benoît Lamarche, PhD

Role: PRINCIPAL_INVESTIGATOR

Laval University

Locations

Institute of Nutrition and Funtional Foods

Québec, , Canada

Countries

Canada

Other Identifiers

INAF_NO_2017-207

Identifier Type: -

Identifier Source: org_study_id