Healthy PeopleNCT06006182
The Effects of Freeze-Dried Whole Grape Powder on Chronic Disease and Cardiovascular Risk Factors-a Pilot Study
A study testing Grape Powder in people with Healthy People, run by California State Polytechnic University, Pomona at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy People
- What is being tested?
- Grape Powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2023to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy People
- Being tested
- Grape Powder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grape PowderOther
Freeze-dried grape powder
| Study group | Role | What they receive |
|---|---|---|
| Group A-Grape Powder then Placebo | Experimental | 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 Receives: Other: Grape Powder |
| Group B-Placebo-then Grape Powder | Placebo comparator | Group B block will be the Placebo for the first 8 weeks, and then after the washout period, they will begin the Grape Powder Receives: Other: Grape Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular Risk Blood Indicators
To determine if grape consumption changes (mg/d) fasting blood glucose, total cholesterol, low density lipoproteins, high density lipoproteins, and triacylglycerides
Measured: 8 weeks for placebo, 8 weeks for grape arms
Secondary outcomes (12)
Body Composition Changes-Percent Body Fat
To determine if grape consumption changes percent body fat.
Measured: 8 weeks for placebo, 8 weeks for grape arms
Body Composition Changes-Body Water
To determine if grape consumption changes (Kg) body water.
Measured: 8 weeks for placebo, 8 weeks for grape arms
Body Composition Changes-Lean Body Tissue
To determine if grape consumption changes (Kg) body lean tissue.
Measured: 8 weeks for placebo, 8 weeks for grape arms
Inflammatory Factors-C-Reactive Protein
To determine if grape consumption changes inflammation as measured by changes (pg/mL) in C-reactive protein.
Measured: 8 weeks for placebo, 8 weeks for grape arms
Inflammatory Factors-Tumor Necrosis Factor Alpha
To determine if grape consumption changes inflammation as measured by changes (mg/L) in tumor necrosis factor alpha
Measured: 8 weeks for placebo, 8 weeks for grape arms
Blood Pressure
To determine if grape consumption changes (mm Hg) blood pressure.
Measured: 8 weeks for placebo, 8 weeks for grape arms
Dietary Analysis-Obtain Diet Recalls
To obtain (3) 24-hour diet recalls per person in each treatment arm.
Measured: 8 weeks for placebo, 8 weeks for grape arms
Dietary Analysis- Diet Intake
To assess changes in (g) dietary intake from the (3) 24-hour recalls in each treatment arm.
Measured: 3 times during the 8 weeks of each arm
Dietary Analysis-Diet Antioxidants
To assess changes in (mg) dietary antioxidants consumed and antioxidant supplement use from the (3) 24-hour recalls.
Measured: 8 weeks for placebo, 8 weeks for grape arms
Dietary Analysis-Diet Comparison
To assess changes in diet quality by comparing the placebo diet analyses with the grape diet analyses from the (3) 24-hour recalls.
Measured: 8 weeks for placebo, 8 weeks for grape arms
High Blood Pressure Blood Indicators
To determine if grape consumption changes (mg/d) blood calcium, potassium and sodium.
Measured: 8 weeks for placebo, 8 weeks for grape arms
Satiety
Using a visual analog scale, determine if grape consumption changes satiety.
Measured: 3 times during the 8 weeks of each arm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start10 Oct 2023
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Healthy PeopleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The crossover design can differentiate the diet treatment effect from other effects like secular trends and differential carryover, utilizes a perfect control (the experimental subject is the same person as the control), the subjects will experience all treatments (best for subject retention), and this study design does not require very many participants to provide adequate study power. The alpha is set at 0.05, and the power at 80%. Based on the calculations, the required number of participants in order to see a difference is 22. However, since a crossover study assumes a \>20% dropout rate, the minimum of 20% is added to the minimum sample size of 22 at an alpha of 0.05 and a power of 80 (14). Therefore, we will be recruiting 30 adults. Since a parallel design would require 58 per treatment group (total=116), it was determined by the PIs that the crossover design was the best design for this study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- California State Polytechnic University, Pomona
- Sponsor type
- University, hospital or other
- Collaborators
- The California Table grape Commission
- Responsible party
- Principal investigator, Dr. Bonny Burns-Whitmore, RD, California State Polytechnic University, Pomona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06006182
- Sponsor's protocol ID
- 100060
- Other IDs
- 24-04-101
- Status last verified
- Jul 2024
- First submitted
- 1 Aug 2023
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to share the data with other researchers.
Publications
1. Centers for Disease Control and Prevention, National Center for Health Statistics. About Multiple Cause of Death, 1999-2020. CDC WONDER Online Database website. Atlanta, GA: Centers for Disease Control and Prevention; 2022. Accessed January 14, 2023
2. Diabetes in Control. New and Information for Medical Professionals. Hyperglycemia Starts at 90mg.dL, That's Right Hyperglycemia. Online website. Accessed January 14, 2023
Nelson RH. Hyperlipidemia as a risk factor for cardiovascular disease. Prim Care. 2013 Mar;40(1):195-211. doi: 10.1016/j.pop.2012.11.003. Epub 2012 Dec 4.
PubMed 234024694. Centers for Disease Control and Prevention. CDC 24/7: Saving Lives, Protecting People. Salt. Sodium, Potassium and Health. Online website. Accessed January 14, 2023.
Arulselvan P, Fard MT, Tan WS, Gothai S, Fakurazi S, Norhaizan ME, Kumar SS. Role of Antioxidants and Natural Products in Inflammation. Oxid Med Cell Longev. 2016;2016:5276130. doi: 10.1155/2016/5276130. Epub 2016 Oct 10.
PubMed 278037626. National Center for Complementary and Integrative Health (NCCIH). Antioxidants: In Depth. https://nccih.nih.gov/health/antioxidants/introduction.htm. Online website. Accessed January 14, 2023.
7. USDA Oxygen Radical Absorbance Capacity (ORAC) of Selected Foods, Release 2 (2010). http://www.orac-info-portal.de/download/ORAC_R2.pdf Accessed January 12, 2024.
Aune D, Giovannucci E, Boffetta P, Fadnes LT, Keum N, Norat T, Greenwood DC, Riboli E, Vatten LJ, Tonstad S. Fruit and vegetable intake and the risk of cardiovascular disease, total cancer and all-cause mortality-a systematic review and dose-response meta-analysis of prospective studies. Int J Epidemiol. 2017 Jun 1;46(3):1029-1056. doi: 10.1093/ije/dyw319.
PubMed 28338764Miller V, Mente A, Dehghan M, Rangarajan S, Zhang X, Swaminathan S, Dagenais G, Gupta R, Mohan V, Lear S, Bangdiwala SI, Schutte AE, Wentzel-Viljoen E, Avezum A, Altuntas Y, Yusoff K, Ismail N, Peer N, Chifamba J, Diaz R, Rahman O, Mohammadifard N, Lana F, Zatonska K, Wielgosz A, Yusufali A, Iqbal R, Lopez-Jaramillo P, Khatib R, Rosengren A, Kutty VR, Li W, Liu J, Liu X, Yin L, Teo K, Anand S, Yusuf S; Prospective Urban Rural Epidemiology (PURE) study investigators. Fruit, vegetable, and legume intake, and cardiovascular disease and deaths in 18 countries (PURE): a prospective cohort study. Lancet. 2017 Nov 4;390(10107):2037-2049. doi: 10.1016/S0140-6736(17)32253-5. Epub 2017 Aug 29.
PubMed 2886433110. Mayo Clinic. Healthy Lifestyle. Nutrition and healthy eating. DASH diet: Healthy eating to lower your blood pressure. Online website. Accessed December 12, 2022.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06006182
- Acronym / sponsor ID
- 100060
- Conditions
- Healthy People
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- California State Polytechnic University, PomonaUniversity, hospital or other
- Collaborators
- The California Table grape Commission
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 23 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The crossover design can differentiate the diet treatment effect from other effects like secular trends and differential carryover, utilizes a perfect control (the experimental subject is the same person as the control), the subjects will experience all treatments (best for subject retention), and this study design does not require very many participants to provide adequate study power. The alpha is set at 0.05, and the power at 80%. Based on the calculations, the required number of participants in order to see a difference is 22. However, since a crossover study assumes a >20% dropout rate, the minimum of 20% is added to the minimum sample size of 22 at an alpha of 0.05 and a power of 80 (14). Therefore, we will be recruiting 30 adults. Since a parallel design would require 58 per treatment group (total=116), it was determined by the PIs that the crossover design was the best design for this study.
| Arm | Type | Receives |
|---|---|---|
| Group A-Grape Powder then Placebo | Experimental | Other: Grape PowderGroup 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 |
| Group B-Placebo-then Grape Powder | Placebo comparator | Other: Grape PowderGroup B block will be the Placebo for the first 8 weeks, and then after the washout period, they will begin the Grape Powder |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Grape PowderFreeze-dried grape powder | Other | Group A-Grape Powder then Placebo, Group B-Placebo-then Grape Powder |
Primary outcome
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
12 secondary outcomes
Body Composition Changes-Percent Body Fat
Time frame: 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
Body Composition Changes-Lean Body Tissue
Time frame: 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
Inflammatory Factors-Tumor Necrosis Factor Alpha
Time frame: 8 weeks for placebo, 8 weeks for grape arms
Blood Pressure
Time frame: 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
Dietary Analysis- Diet Intake
Time frame: 3 times during the 8 weeks of each arm
Dietary Analysis-Diet Antioxidants
Time frame: 8 weeks for placebo, 8 weeks for grape arms
Dietary Analysis-Diet Comparison
Time frame: 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
Satiety
Time frame: 3 times during the 8 weeks of each arm
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- Background1. Centers for Disease Control and Prevention, National Center for Health Statistics. About Multiple Cause of Death, 1999-2020. CDC WONDER Online Database website. Atlanta, GA: Centers for Disease Control and Prevention; 2022. Accessed January 14, 2023
- Background2. Diabetes in Control. New and Information for Medical Professionals. Hyperglycemia Starts at 90mg.dL, That's Right Hyperglycemia. Online website. Accessed January 14, 2023
- Background: PubMed 23402469Nelson RH. Hyperlipidemia as a risk factor for cardiovascular disease. Prim Care. 2013 Mar;40(1):195-211. doi: 10.1016/j.pop.2012.11.003. Epub 2012 Dec 4.
- Background4. Centers for Disease Control and Prevention. CDC 24/7: Saving Lives, Protecting People. Salt. Sodium, Potassium and Health. Online website. Accessed January 14, 2023.
- Background: PubMed 27803762Arulselvan P, Fard MT, Tan WS, Gothai S, Fakurazi S, Norhaizan ME, Kumar SS. Role of Antioxidants and Natural Products in Inflammation. Oxid Med Cell Longev. 2016;2016:5276130. doi: 10.1155/2016/5276130. Epub 2016 Oct 10.
- Background6. National Center for Complementary and Integrative Health (NCCIH). Antioxidants: In Depth. https://nccih.nih.gov/health/antioxidants/introduction.htm. Online website. Accessed January 14, 2023.
- Background7. USDA Oxygen Radical Absorbance Capacity (ORAC) of Selected Foods, Release 2 (2010). http://www.orac-info-portal.de/download/ORAC_R2.pdf Accessed January 12, 2024.
- Background: PubMed 28338764Aune D, Giovannucci E, Boffetta P, Fadnes LT, Keum N, Norat T, Greenwood DC, Riboli E, Vatten LJ, Tonstad S. Fruit and vegetable intake and the risk of cardiovascular disease, total cancer and all-cause mortality-a systematic review and dose-response meta-analysis of prospective studies. Int J Epidemiol. 2017 Jun 1;46(3):1029-1056. doi: 10.1093/ije/dyw319.
- Background: PubMed 28864331Miller V, Mente A, Dehghan M, Rangarajan S, Zhang X, Swaminathan S, Dagenais G, Gupta R, Mohan V, Lear S, Bangdiwala SI, Schutte AE, Wentzel-Viljoen E, Avezum A, Altuntas Y, Yusoff K, Ismail N, Peer N, Chifamba J, Diaz R, Rahman O, Mohammadifard N, Lana F, Zatonska K, Wielgosz A, Yusufali A, Iqbal R, Lopez-Jaramillo P, Khatib R, Rosengren A, Kutty VR, Li W, Liu J, Liu X, Yin L, Teo K, Anand S, Yusuf S; Prospective Urban Rural Epidemiology (PURE) study investigators. Fruit, vegetable, and legume intake, and cardiovascular disease and deaths in 18 countries (PURE): a prospective cohort study. Lancet. 2017 Nov 4;390(10107):2037-2049. doi: 10.1016/S0140-6736(17)32253-5. Epub 2017 Aug 29.
- Background10. Mayo Clinic. Healthy Lifestyle. Nutrition and healthy eating. DASH diet: Healthy eating to lower your blood pressure. Online website. Accessed December 12, 2022.
- Individual participant dataSharing planned: No. We do not plan to share the data with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Grape Powder in people with Healthy People, run by California State Polytechnic University, Pomona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular Risk Blood Indicators (time frame: 8 weeks for placebo, 8 weeks for grape arms). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06006182, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2024.