MegaNatural BP® GSE on Blood Pressure and Cardiometabolic Risk Factors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Difference in change of diastolic blood pressure
研究概览
简要总结
Inflammation and stressors can interfere with the function of the lining of blood vessels and insulin activity, therefore, investigators are aiming to see how the Grape seed Extract (GSE) called MegaNatural BP can help with limiting the effects of these factors. This research will study the effects of taking 150mg of MegaNatural BP GSE per day on blood pressure levels along with influences on heart health through assessing the function of the blood vessel lining and levels of inflammation.
详细描述
This is a research study to determine if an extract made from grape seeds might help control blood pressure. Previous research studies have found that taking this extract as a daily supplement at 300 mg per day in a capsule or a beverage may lower blood pressure in individuals with elevated blood pressure levels. The commercial name of this supplement is called MegaNatural BP®. The principal investigators of this study were part of the original research studies on GSE (both MegaNatural BP GSE and MegaNatural Gold GSE). They are now interested to determine if a lower amount of the grape seed extract might be effective in lowering people's blood pressure when its elevated. There is also some earlier information suggesting the GSE may influence how well insulin works in people's body. This may be helpful for individuals with metabolic conditions like the early stages of pre-diabetes.
The study will last for six weeks. All participants will visit the Clinical Nutrition Research Center (CNRC) seven times over the course of the study. These visits include a screening visit, two ambulatory blood pressure device fitting visits, and four study day visits throughout the six weeks. Blood will be collected to assess insulin activity measures during subject visits to the CNRC. The flexibility of subject's blood vessels will be measured using an ultrasound technique. Flexibility of vessels is important for blood pressure regulation and GSE has been known to help them become more flexible.
SCREENING VISIT
A subject's eligibility for the study is based on the list (inclusion and exclusion criteria). Clinical Research Coordinators will determine if the subject qualifies for the study at the Screening Visit by the following measurements:
- General measurements: height, weight, body composition and body temperature
- Fasting blood glucose from a finger prick
- Blood pressure
- Pregnancy test, for women under the age of 60 During the visit, the subject will be asked to complete a questionnaire or answer questions related to their health, dietary habits, and physical activity history. Based on the results of the blood sugar, questionnaires, measurements and evaluation of their health, the subject may meet the criteria and be invited to participate in 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
- Double (Participant, Investigator)
盲法说明
double-blind
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •40-60 years of age
- •BMI < 30kg/m2
- •elevated blood pressure 120-140 mmHg (systolic) / <90 mmHg (diastolic) at screening visit
- •Has fasting blood glucose concentration between 100-125 mg/dL or HbA1c 5.7-6.4%.
- •Not taking any medications that would interfere with outcomes of the study, i.e. blood pressure lowering medications or anti-diabetes medications.
- •Able to provide informed consent
- •Able to comply and perform the procedures requested by the protocol (including dietary restrictions, consumption of study foods, records of food diary and GI tolerance questionnaire, sample collection procedures and study visit schedule)
- •Able to maintain usual physical activity pattern
- •Able to avoid / abstain from alcohol and vigorous physical activity for 24 hours prior to and during study visit
排除标准
- •Men and women with known or suspected intolerance, allergies or hypersensitivity to study foods or interventions
- •Men and women with diabetes or have documented liver, kidney, cardiac, gastrointestinal, metabolic or respiratory diseases.
- •Men and women with documented physical or mental disease/condition or major surgery as revealed by history or physical examination, which might limit participation in or completion of the study or, that, in the opinion of the investigator, could interfere with the interpretation of the study results.
- •Women who are known to be pregnant or who are intending to become pregnant over the course of the study
- •Women who are lactating
- •Taking medication or dietary supplements that may interfere with the outcomes of the study; This may include anti-inflammatory medication (ibuprofen, Aleve/naproxen, aspirin, etc.)
- •Major trauma or a surgical event within 2 months (or longer depending on trauma or event) and after consultation with PI.
- •Has used antibiotics within the previous 2 months
- •Had colonoscopy within 3 months
- •History of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional
- •Substance (alcohol or drug) abuse within the last 2 years
- •Excessive coffee and tea consumers (> 4 cups/d)
- •Donated blood within last 3 months
- •Men and women who do excessive exercise regularly or are an athlete
- •Unstable weight: gained or lost weight +/- 5 kg (11 lbs) in previous 2 months
- •Women who are taking unstable dose and brand of hormonal contraceptives and/or stable dose and brand less than 6 months
- •Unusual working hours i.e., working overnight (e.g. 3rd shift)
- •Follows a vegan diet or any extreme dietary patterns
研究组 & 干预措施
GSE Capsule
150mg Grapeseed Extract MegaNatural BP
干预措施: MegaNatural-BP SR 150Mg Tablet (Dietary Supplement)
Placebo Capsule
Placebo supplement in place of GSE capsule
干预措施: Placebo Capsule (Other)
结局指标
主要结局
Difference in change of diastolic blood pressure
时间窗: 6 weeks
After 6 weeks of 150mg GSE MegaNatural BP per day the base level blood pressure should change
Difference in change of systolic blood pressure
时间窗: 6 weeks
After 6 weeks of 150mg GSE MegaNatural BP per day the base level blood pressure should change
次要结局
- Change in vessel flexibility(6 weeks)
- Change in inflammatory marker C-reactive protein(6 weeks)
- Change in GSE metabolites profiles(6 weeks)
- Change in fasting and postprandial insulin(6 weeks)
- Change in fasting and postprandial glucose(6 weeks)
- Change in the ratio of arginine:ADMA(6 weeks)