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

July 17, 2024 updated by: Dr. Bonny Burns-Whitmore, RD, California State Polytechnic University, Pomona

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

As well, three 24-hour randomized diet recalls will be administered during each treatment to obtain information regarding the subject's diet and adherence to the diet protocol, and ESHA Research Food Processor will be used to analyze the diet. Adherence to the assigned diets will be assessed using an Unusual Diet Diary, which is filled out by the participant when unusual quantities of foods or accidental grape consumption occurs, medical treatment is required, pharmaceuticals/antioxidant supplements are consumed, or the participant exercises to excess. Visual Analog Questionnaires will be used to determine satiety and hunger during both study periods the day after the diet recall is obtained.

Subjects will pick up their study material allotment every week from the PI's office which is in room #119 in the Don B. Huntley College of Agriculture at Cal Poly Pomona. After Informed Consent is obtained, subjects will be instructed on how to mix the freeze-dried powder into the water as per the California Table Grape protocol.

Timetable The study timeline is 1 year, (includes subject recruitment, the study duration, laboratory analyses, and 2-3 months to organize and analyze the data, provide a report to the funders, and publish the results). The study, after obtaining participants, will commence at the beginning of August 2023, and end July 31, 2024. The two Co-PIs, two graduate students and 4 undergraduate students will conduct this study. The undergraduate students will help in recruitment and retention as well as performing, input and analysis of the 24-hour recalls in the ESHA software, Tanita measurements, passing out the subject's allocations, and tabulating the questionnaires.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Pomona, California, United States, 91768
        • Cal Poly Pomona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A-Grape Powder then Placebo
Group A block will be the Grape Powder for the first 8 weeks, and then after the washout period, they will begin the Placebo. The experimental Grape Powder is a food-it is simply freeze-dried grape powder
Other: Grape Powder
Freeze-dried grape powder
Placebo Comparator: Group B-Placebo-then Grape Powder
Group B block will be the Placebo for the first 8 weeks, and then after the washout period, they will begin the Grape Powder
Other: Grape Powder
Freeze-dried grape powder

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular Risk Blood Indicators
Time Frame: 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
8 weeks for placebo, 8 weeks for grape arms

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Composition Changes-Percent Body Fat
Time Frame: 8 weeks for placebo, 8 weeks for grape arms
To determine if grape consumption changes percent body fat.
8 weeks for placebo, 8 weeks for grape arms
Body Composition Changes-Body Water
Time Frame: 8 weeks for placebo, 8 weeks for grape arms
To determine if grape consumption changes (Kg) body water.
8 weeks for placebo, 8 weeks for grape arms
Body Composition Changes-Lean Body Tissue
Time Frame: 8 weeks for placebo, 8 weeks for grape arms
To determine if grape consumption changes (Kg) body lean tissue.
8 weeks for placebo, 8 weeks for grape arms
Inflammatory Factors-C-Reactive Protein
Time Frame: 8 weeks for placebo, 8 weeks for grape arms
To determine if grape consumption changes inflammation as measured by changes (pg/mL) in C-reactive protein.
8 weeks for placebo, 8 weeks for grape arms
Inflammatory Factors-Tumor Necrosis Factor Alpha
Time Frame: 8 weeks for placebo, 8 weeks for grape arms
To determine if grape consumption changes inflammation as measured by changes (mg/L) in tumor necrosis factor alpha
8 weeks for placebo, 8 weeks for grape arms
Blood Pressure
Time Frame: 8 weeks for placebo, 8 weeks for grape arms
To determine if grape consumption changes (mm Hg) blood pressure.
8 weeks for placebo, 8 weeks for grape arms
Dietary Analysis-Obtain Diet Recalls
Time Frame: 8 weeks for placebo, 8 weeks for grape arms
To obtain (3) 24-hour diet recalls per person in each treatment arm.
8 weeks for placebo, 8 weeks for grape arms
Dietary Analysis- Diet Intake
Time Frame: 3 times during the 8 weeks of each arm
To assess changes in (g) dietary intake from the (3) 24-hour recalls in each treatment arm.
3 times during the 8 weeks of each arm
Dietary Analysis-Diet Antioxidants
Time Frame: 8 weeks for placebo, 8 weeks for grape arms
To assess changes in (mg) dietary antioxidants consumed and antioxidant supplement use from the (3) 24-hour recalls.
8 weeks for placebo, 8 weeks for grape arms
Dietary Analysis-Diet Comparison
Time Frame: 8 weeks for placebo, 8 weeks for grape arms
To assess changes in diet quality by comparing the placebo diet analyses with the grape diet analyses from the (3) 24-hour recalls.
8 weeks for placebo, 8 weeks for grape arms
High Blood Pressure Blood Indicators
Time Frame: 8 weeks for placebo, 8 weeks for grape arms
To determine if grape consumption changes (mg/d) blood calcium, potassium and sodium.
8 weeks for placebo, 8 weeks for grape arms
Satiety
Time Frame: 3 times during the 8 weeks of each arm
Using a visual analog scale, determine if grape consumption changes satiety.
3 times during the 8 weeks of each arm

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

California State Polytechnic University, Pomona

Collaborators

The California Table grape Commission

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2023

Primary Completion (Actual)

June 30, 2024

Study Completion (Actual)

June 30, 2024

Study Registration Dates

First Submitted

August 1, 2023

First Submitted That Met QC Criteria

August 20, 2023

First Posted (Actual)

August 23, 2023

Study Record Updates

Last Update Posted (Actual)

July 19, 2024

Last Update Submitted That Met QC Criteria

July 17, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 100060
  • 24-04-101 (Other Identifier: Agriculture Research Institute)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We do not plan to share the data with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy People

Clinical Trials on Grape Powder

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ireland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe