The Effects of Freeze-Dried Whole Grape Powder on Chronic Disease and Cardiovascular Risk Factors-a Pilot Study

Completed · Not applicable · Has a placebo group

Conditions studied: Healthy People

In brief

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.

Key facts

Study ID

NCT06006182

Run by

California State Polytechnic University, Pomona

People needed

30

Starts

2023-10-10

Expected to finish

2024-06-30

Last updated by the study team

2024-07-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• Do not attend or are not employed by Cal Poly Pomona
• Smokers
• 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
• Cancer
• Cardiovascular diseases
• Body piercings that cannot be removed
• Implanted devices
• Not available for 8 weeks during both (2023) and Spring (2024) semesters.

Where it is running

• Cal Poly Pomona — Pomona, California, United States

Full record on ClinicalTrials.gov

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