Hypertension Clinical Trial
Official title:
Impact of a Supplementation With Grape Seed and Cranberry Extracts on Ambulatory Blood Pressure
Verified date | February 2020 |
Source | Laval University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 73 |
Est. completion date | January 15, 2021 |
Est. primary completion date | June 12, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Institute of Nutrition and Funtional Foods | Québec |
Lead Sponsor | Collaborator |
---|---|
Laval University | Atrium Innovations |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 24-hour ambulatory systolic blood pressure | Comparison of the change from baseline in 24-hr ambulatory systolic blood pressure at 6-wk between the NO Ultra group and the placebo group. | 6 weeks (end-point value) | |
Secondary | Blood Lipids | Comparison of the change from baseline in serum total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, non HDL cholesterol, TG, and apolipoprotein B levels as well as in the total cholesterol/HDL cholesterol ratio at 6-wk between the NO Ultra group and the placebo group. The concentration of the above lipids will be assessed on a Roche/Hitachi Modular analytical system (Roche Diagnostics) according to the manufacturer's specifications and using proprietary reagents. Serum LDL cholesterol concentrations will be calculated using the Friedewald equation. |
6 weeks (end-point value) | |
Secondary | Vascular function | Comparison of the change from baseline in serum markers of vascular function including concentrations of angiotensin-converting enzyme (ACE), angiotensin-II (A-II), aldosterone (ALDOS), soluble forms of intercellular adhesion molecules (sICAM-1), soluble form of vascular cell adhesion molecule-1 (sVCAM-1) and soluble form of E-selectin (sE-selectin), as well as in the skin concentration of advanced glycation end products (AGEs) at 6-wk between the NO Ultra group and the placebo group. Plasma concentrations of ACE, A-II, aldosterone ALDOS, sICAM-1, sVCAM-1 and sE-selectin will be determined using commercial ELISA kits for the human form of these markers. Measurement of the skin concentration of AGEs iwill be performed using a sensitive optical measurement device called AGE scanner (DiagnOptics, Groningen, The Netherlands). |
6 weeks (end-point value) | |
Secondary | Inflammation biomarkers | Comparison of the change from baseline in serum levels of C-reactive protein (CRP), interleukin-6 (IL-6), IL-18 and tumor necrosis factor alpha (TNF-a) at 6-wk between the NO Ultra group and the placebo group. Serum CRP concentrations will be measured using of the Behring Latex-Enhanced highly sensitive assay on the Behring Nephelometer BN-100 system. Serum IL-6, IL-18, and TNF-alpha concentrations will be determined using commercial ELISA kits for the human form of these cytokines. |
6 weeks (end-point value) |
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