The Effects of Freeze-Dried Whole Grape Powder on Chronic Disease and Cardiovascular Risk Factors, Hunger, Satiety, and Body Composition in Free-Living People-a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Cardiovascular Risk Blood Indicators
研究概览
简要总结
Cardiovascular disease (CVD) is responsible for 1 out of every 5 deaths, is the number one killer of Americans, killing about 700K US adults per year (1). Our proposed research is a clinical trial that will determine the effects of feeding California freeze-dried grapes (which are directly comparable to fresh table grapes), on cardiovascular and chronic disease risk factors, namely, blood glucose and lipids (total cholesterol, LDL, HDL, and triacylglycerides), electrolyte and blood indicators (such as sodium, calcium, potassium, etc.), c-reactive protein (hs-CRP) and tumor necrosis factor alpha (TNF-alpha) (measures of inflammation and CVD risk), body composition (body weight, body fat percentage, lean tissue weight, body water amount and Kcal requirement to maintain body composition status), and blood pressure (BP) in 30 adults. The investigators will test satiety and hunger to see if grape antioxidants decrease both, implying that there will be a decrease in caloric intake and result in body composition improvements.
详细描述
METHODOLOGY/EXPERIMENTAL DESIGN-CROSSOVER
We plan to test the effects of feeding grapes (using the supplied freeze-dried grape powder from the California Table Grape Commission) in subjects aged 18 years of age or older. This study will be done in a free-living population, using a double-blinded randomized clinical trial (RCT) crossover study design at California Polytechnic University, Pomona
There will be a 3-month recruitment and screening period in which approximately 60 persons will be screened. There will be two 8-week randomized diet periods (to either Group A or B) separated by a washout period. Subjects will follow each of the randomly assigned diets: Freeze-Dried Grapes (Experimental/Treatment) for 8 weeks or Freeze-Dried Control (supplied by California Table Grape Commission), once a day for 8 weeks. The control diet-consumed during one of the treatment arm periods-will consist of the person's normal (habitual) diet with the absence of grapes in any form (including alcohol) and a grape-look alike placebo. The experimental diet will consist of the normal (habitual) diet of each subject, with the addition of the freeze-dried grapes in a 6 oz glass of water per day and the absence of grapes in any form. There will be a 5-8 week washout period between the two treatments.
Blood drawings, BP, hs-CRP and TNF-alpha, and body composition measurements will be performed on each subject at week 0, and after 8 weeks of each period arms. A phlebotomist at the California Polytechnic University, Pomona (CPP) Student Health Center, will draw the blood samples. An independent laboratory will analyze the coded blood samples for triglycerides, glucose, hs-CRP and TNF-alpha, total blood cholesterol, LDL, and HDL cholesterol levels.
Body composition will be measured using a Tanita Bioimpedance scale (T-310) and blood pressure will be taken with the OMRON blood pressure monitor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
盲法说明
Double blinded
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Apparently healthy adults
- •Attend school at or are employed by Cal Poly Pomona
- •Not sensitive or allergic to grapes or grape products.
- •Must be available 8 weeks during both Fall (2023) and Spring (2024) semesters.
排除标准
- •Do not attend or are not employed by Cal Poly Pomona
- •Pregnancy
- •Any allergies to or dislike of grapes
- •Cross-reactive allergies to grapes such as any of the following: peach, tree nuts, mustard, mulberry, cabbage, figs, kiwi, bananas, melon, apple, cherries, strawberries
- •Thyroid disease
- •Insulin dependent diabetes
- •Non-insulin dependent diabetes
- •Cardiovascular diseases
- •Body piercings that cannot be removed
- •Implanted devices
- •Not available for 8 weeks during both (2023) and Spring (2024) semesters.
结局指标
主要结局
Cardiovascular Risk Blood Indicators
时间窗: 8 weeks for placebo, 8 weeks for grape arms
To determine if grape consumption changes (mg/d) fasting blood glucose, total cholesterol, low density lipoproteins, high density lipoproteins, and triacylglycerides
次要结局
- Body Composition Changes-Percent Body Fat(8 weeks for placebo, 8 weeks for grape arms)
- Inflammatory Factors-C-Reactive Protein(8 weeks for placebo, 8 weeks for grape arms)
- Dietary Analysis- Diet Intake(3 times during the 8 weeks of each arm)
- Body Composition Changes-Body Water(8 weeks for placebo, 8 weeks for grape arms)
- Dietary Analysis-Obtain Diet Recalls(8 weeks for placebo, 8 weeks for grape arms)
- Blood Pressure(8 weeks for placebo, 8 weeks for grape arms)
- Dietary Analysis-Diet Comparison(8 weeks for placebo, 8 weeks for grape arms)
- High Blood Pressure Blood Indicators(8 weeks for placebo, 8 weeks for grape arms)
- Body Composition Changes-Lean Body Tissue(8 weeks for placebo, 8 weeks for grape arms)
- Inflammatory Factors-Tumor Necrosis Factor Alpha(8 weeks for placebo, 8 weeks for grape arms)
- Dietary Analysis-Diet Antioxidants(8 weeks for placebo, 8 weeks for grape arms)
- Satiety(3 times during the 8 weeks of each arm)
研究者
Dr. Bonny Burns-Whitmore, RD
Professor/Researcher
California State Polytechnic University, Pomona