Impact of a Supplementation With Grape Seed and Cranberry Extracts on Ambulatory Blood Pressure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 2
- 主要终点
- 24-hour ambulatory diastolic blood pressure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
24-hour ambulatory diastolic blood pressure
时间窗: 6 weeks (end-point value)
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.
次要结局
- 24-hour ambulatory systolic blood pressure(6 weeks (end-point value))
- Blood Lipids(6 weeks (end-point value))
- Inflammation biomarkers(6 weeks (end-point value))
- Vascular function(6 weeks (end-point value))