NCT06440252已完成3 期
The Effectiveness of a Grape Seed Extract on Circulatory Measures in Healthy Adults: a Randomised, Double-blind, Placebo-controlled Crossover Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Change in Diastolic blood pressure (arm)
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, 2 arm crossover study conducted over 11 weeks, with participants randomised to a product for 4 weeks, followed by a 3-week washout period before completing the second product for 4 weeks, to study the effectiveness of a grape seed extract on circulatory measures in healthy adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 25 years or older
- •Generally healthy
- •BMI 18 - 35kg/m2
- •Able to provide informed consent
- •Have prehypertensive blood pressure (systolic 120-139 mmHg and/or diastolic 80-89 mmHg)
- •Agree to not change current diet and/or exercise frequency or intensity during entire study period
- •Agree to not participate in another clinical trial while enrolled in this trial
排除标准
- •Those with a history of myocardial infarction, angina or bleeding disorders
- •Those who have uncontrolled thyroid diseases
- •Currently taking dietary supplements for circulation (e.g. fatty acids, CoQ10, L-arginine, red ginseng, ginseng, natto, ginkgo) or use of these in the last 1 month
- •Currently taking inflammation or circulatory associated medications (e.g. Pentoxifylline and vasodilators like nitroglycerin) or use of these in the last 1 month
- •Currently taking statins medication including atorvastatin (e.g. Lipitor, Lorstat), fluvastatin (e.g. Lescol or Vastin), pravastatin (e.g. Pravachol, Cholstat), rosuvastatin (e.g. Cavstat, Crestor) or simvastatin (e,g, Lipex, Zocor, Zimstat).
- •Currently taking Coumadin, Marevan (Warfarin), Heparin, Dalteparin, Enoxaparin or other anticoagulation therapy, or substrates of P-glycoprotein including (but not limited to) calcium channel blockers, cyclosporin, digoxin, erythromycin and protease inhibitors(1).
- •Have a serious illness(2) e.g. mood disorders such as bipolar disorder, neurological disorders such as MS, kidney disease, liver disease or heart conditions
- •Have an unstable illness(3) (i.e., changing medication/treatment)
- •Malignancy or treatment for malignancy within the previous 2 years (this excludes non-melanoma (e.g. BCC and SCC) skin cancers not requiring radiation or chemotherapy)
- •Active smokers, nicotine use or drug (prescription or illegal substances) abuse
- •Chronic past and/or current alcohol use (>14 alcoholic drinks week)
- •Allergic to any of the ingredients in active or placebo formula
- •Pregnant or lactating woman or women trying to conceive
- •Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
- •Participated in another trial in the past 1 month
- •Any participant that begins taking antiplatelet medication during the trial will be excluded from the study
- •A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments.
- •An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity.
研究组 & 干预措施
Grape Seed Extract
Active Comparator
Grape seed extract 600mg per day - 1 capsule per day
干预措施: Grape Seed Extract (Drug)
Maltodextrin
Placebo Comparator
Maltodextrin - 1 capsule per day
干预措施: Maltodextrin (Drug)
结局指标
主要结局
Change in Diastolic blood pressure (arm)
时间窗: Baseline, week 4, week 8, week 11
Change in Diastolic blood pressure (arm) as measured by blood pressure machine
次要结局
- Change in Peripheral systolic and diastolic blood pressure (leg)(Baseline, week 4, week 8, week 11)
- Change in HGB(Baseline, week 4, week 8, week 11)
- Change in WBC(Baseline, week 4, week 8, week 11)
- Change in RBC(Baseline, week 4, week 8, week 11)
- Change in Platelet Aggregation(Baseline, week 4, week 8, week 11)
- Change in Systolic blood pressure (arm)(Baseline, week 4, week 8, week 11)
- Change in (endothelial nitric oxide synthase) eNOS(Baseline, week 4, week 8, week 11)
- Change in endogenous nitric oxide (NO)(Baseline, week 4, week 8, week 11)
- Change in Tibial artery structure(Baseline, week 4, week 8, week 11)
- Change in triglycerides(Baseline, week 4, week 8, week 11)
- Change in blood flow of the right leg(Baseline, week 4, week 8, week 11)
- Change in oxygen saturation(Baseline, week 4, week 8, week 11)
- Change in resting pulse rate(Baseline, week 4, week 8, week 11)
- Change in weight(Baseline, week 4, week 8, week 11)
- Change in Body Mass Index (BMI)(Baseline, week 4, week 8, week 11)
- Change in waist and hip circumference(Baseline, week 4, week 8, week 11)
- Change in 36-Item Short Form Health Survey (SF-36)(Baseline, week 4, week 8, week 11)
- Change in E/LFT(Baseline, week 4, week 8, week 11)
- Change in cholesterol(Baseline, week 4, week 8, week 11)
- Change in blood glucose(Baseline, week 4, week 8, week 11)
- Change in adverse events(Baseline, week 4, week 8, week 11)
研究者
研究点 (1)
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