The Effects Grapes on Health Indices



Status:Completed
Conditions:Obesity Weight Loss, Other Indications, Peripheral Vascular Disease
Therapuetic Areas:Cardiology / Vascular Diseases, Endocrinology, Other
Healthy:No
Age Range:18 - 70
Updated:4/21/2016
Start Date:August 2012
End Date:April 2015

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Pilot Study: The Effects of Whole Grapes on Markers of Health

The investigators hope to learn about the effects of whole grapes, in the form of
freeze-dried grape powder, on markers of health. Phytochemical rich food consumption is
associated with protection against chronic diseases such as cardiovascular disease (CVD)
demonstrating the ability to modify endothelial function and lipemia, but exact causal
mechanisms are still not well understood. The investigators will examine metabolic and
mechanistic effects of consumption of whole grape powder in chronic as well as acute
settings in response to meal challenges by testing blood samples to determine if markers of
health have improved.

The central hypothesis of this project is that consumption of grapes in the form of a
polyphenol-rich freeze-dried whole grape powder (WGP) will attenuate chronic and meal
induced oxidative stress and inflammatory responses in obese individuals.

The specific aims are to:

1. Assess the effect of WGP compared to placebo on biomarkers of oxidative stress and
inflammation in obese subjects over 4 week intervention periods in a randomized,
cross-over, double-blind study.

2. Determine the effects of WGP compared to placebo on lipid and apolipoprotein
parameters, and on biomarkers endothelial dysfunction, in obese subjects.

3. Investigate and characterize the effects of WGP compared to placebo on mononuclear
cells (MNC) from obese subjects in response to the oxidative challenge of a high fat,
high carbohydrate (HFHC) meal by examining monocyte indices such as oxidant
stress-related transcription factors and downstream gene targets.

Health promotion and prevention of chronic diseases in the face of a continuing obesity
epidemic is the most pressing public health issue today. Epidemiologic evidence supports a
protective effect of plant food-rich dietary patterns, and an inverse relationship of fruit
and vegetable consumption with chronic conditions like cardiovascular disease (CVD).
However, the underlying causal mechanisms are not well understood. Prospective human studies
examining consumption of polyphenol-rich whole grapes or their components have found
benefits on markers of oxidative stress and blood lipids as have other food examples such as
blackcurrant juice and strawberries. Putative mechanisms underlying the positive actions of
polyphenol-rich grapes have been well described in recent reviews. A number of in-vitro cell
culture and in-vivo animal studies with WGP and extracts support these mechanisms. However,
relatively fewer human studies have been conducted examining biomarkers and potential
mechanisms for attenuation of chronic inflammatory responses and meal-induced postprandial
oxidative stress and inflammation in obese humans.

Obesity is a metabolic state recognized as being pro-inflammatory, leading to dysregulation
of endothelial function, glucose and lipoprotein metabolism and cardiovascular risk.
Consumption of high fat diets can further impair vascular reactivity in the postprandial
period. Circulating MNC provide a representation of the overall inflammatory status of the
body, which is accessible and can be used to examine mechanistic processes in response to
chronic and meal-induced oxidative stress. Recent literature reports have described the
effect of polyphenol-rich food consumption and Mediterranean diet patterns to reduce NF-κB
activation as well as changes in downstream inflammatory gene expression in peripheral blood
MNC's. Therefore, the proposed study will exploit this approach to examine short-term
responses to a meal challenge as well as longer-term responses to daily consumption of whole
grapes as assessed by plasma and mononuclear cell indices. This research will shed light on
oxidant stress-related transcription factors and downstream gene targets involved in the
anti-inflammatory effects of grape consumption in obese individuals who are at increased
risk of chronic diseases.

Additional scientific data is needed to understand the links between diet and health and to
develop effective dietary strategies to improve health outcomes, particularly in obesity.
The use of polyphenol-rich whole grape powder to attenuate inflammatory mediators and
biomarkers in blood and mononuclear cells of obese humans represents a targeted intervention
approach in an at-risk population. The goal for the study is to examine the link between the
beneficial effects of grapes as a food and health in a significant public health chronic
disease. The outcomes of the study design will provide preliminary data which bridges
well-controlled human translational research and fundamental research by examining cellular
responses to grape consumption in a human clinical trial. The approach will generate new and
unique data to extend scientific knowledge and allow for the development of a mechanistic
component to a human feeding intervention.

Inclusion Criteria:

- Men and women 18 years of age or older in good health

- BMI >30

Exclusion Criteria:

- Smokers

- Chronic disease, such as diabetes, cancer, and renal, liver or thyroid dysfunction

- History of gastrointestinal disease

- History of cardiovascular events

- If pregnant or lactating

- Regular users of statin drugs, aspirin, anti-inflammatory medications, antioxidants
or botanical supplements

- Allergy to grapes
We found this trial at
1
site
Davis, California 95616
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from
Davis, CA
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