HealthyNCT05025189
The Effect of Grape Consumption on Increasing the Good Bacteria in the Human Intestine
A study testing Table Grape Powder and Beige Diet in people with Healthy, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This pilot study will assess the ability of daily consumption of one dose (2 servings) of freeze-dried whole table grape powder, made from conventionally grown grapes to alter the composition of the bacteria that live in the intestines in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Table Grape Powder and Beige Diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2020to 30 Jul 2021
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy human adults age 18-55 years old (females have to be premenopausal)
- Typically consume low fiber/polyphenol diet (beige diet)
Who cannot join
- Eating a high fiber/polyphenol diet or taking any medication or dietary supplement, which interfere with the absorption of polyphenols.
- History of gastrointestinal surgery, diabetes mellitus on medications, or other serious medical condition, such as chronic hepatic or renal disease, bleeding disorder, congestive heart disease, chronic diarrhea disorders, myocardial infarction, coronary artery bypass graft, angioplasty within 6 months prior to screening, current diagnosis of uncontrolled hypertension (defined as systolic BP >160mmHg, diastolic BP > 95mmHg), active or chronic gastrointestinal disorders, bulimia, anorexia, laxative abuse, or endocrine diseases (except thyroid disease requiring medication) as indicated by medical history or routine physical examination.
- Screening laboratory value outside of the laboratory normal range that is considered clinically significant for study participation by the investigator.
- Is unable or unwilling to comply with the study protocol.
- Using prebiotics, probiotics, yogurt, and/or any fiber supplements regularly
- Allergy or sensitivity to grapes. Subjects will be excluded if there is a prior history of such sensitivity. Since these foods are commonly eaten and allergies are rare, subjects should be aware of this sensitivity prior to entering the study. To determine this, a positive affirmation by the subject of grape ingestion without incident will be requested.
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- Taking antibiotics or laxatives within the past 3 months
- Allergy or sensitivity to grapes. Subjects will be excluded if there is a prior history of such sensitivity. Since these foods are commonly eaten and allergies are rare, subjects should be aware of this sensitivity prior to entering the study. To determine this, a positive history of grape ingestion without incident will be requested. In addition, any subject with a history of allergy or anaphylaxis of any kind will be excluded
- Subjects with known allergy to food coloring dyes.
- In the opinion of the study investigator, any subject who demonstrate a risk of non-compliance with study procedure, or one who cannot read, understand or complete study - related materials.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Center for Human Nutrition
Los Angeles, California, 90024
About this study
Official title: Effect of Grape Consumption on the Microbiome in Healthy Subjects: A Pilot Study
This pilot study will assess the ability of daily consumption of one dose (2 servings) of freeze-dried whole table grape powder, made from conventionally grown grapes to alter the composition of the bacteria that live in the intestines in healthy subjects. The grape powder contains 46g of individually quick frozen (IQF) grapes, which is equivalent to 252g fresh fruit. 20 subjects will will consume the beige diet for 4 weeks followed by one dose (two servings) of standardized Freeze-Dried Whole Table Grape Powder (46g) daily for 4 weeks. The primary objective of this pilot study is to determine changes in the gut microbiome. Stool samples will be collected at 4 and 8 weeks for bacterial DNA to determine changes in the bacteria that live in the intestines. You will be asked to avoid foods rich in polyphenols including dark chocolate and cocoa products, dried herbs, berries, coffee, tea, flaxseeds, nuts (chestnut, hazelnut), olive and artichoke for the duration of the study.
Read the detailed description
The bacterial composition of the intestinal microbiome has been linked to the development of chronic diseases including obesity, metabolic syndrome, type II diabetes and heart disease. Grapes provide a rich source of polyphenols and fiber. It has been demonstrated in animal studies that fruits with high polyphenol content and fiber exhibit prebiotic effects leading to changes in the gut microbiome, decrease in symptoms of metabolic syndrome, improvement in insulin resistance and decrease in intestinal and systemic inflammation. Several human intervention studies have also been performed that demonstrated beneficial effects of high polyphenol fruits on the intestinal microbiome. No information is available about the effect of grape consumption on the gut microbiome. This proposed pilot study will assess the ability of consumption of two servings of grapes daily to alter the gut microbiome composition, leading to increased bile secretion, increased fecal cholesterol degradation/excretion, decreased plasma cholesterol and improved intestinal wellbeing in a free-living population. 20 subjects will consume the beige diet for 4 weeks followed by one dose (two servings) of standardized Freeze-Dried Whole Table Grape Powder (46g) daily for 4 weeks. The primary objective of this pilot study is to determine changes in the gut microbiome. Secondary outcome will be fecal bile and cholesterol and their metabolites, plasma cholesterol and intestinal wellbeing questionnaire at 4 and 8 weeks Stool samples will be collected at 4 and 8 weeks for sequencing of bacterial DNA to determine changes in the microbiota. Changes in fecal bile, cholesterol, and cholesterol metabolites will be analyzed by gas chromatography. The objective of the proposed pilot study is to determine whether intake of 2 servings of grapes per day will alter the intestinal microflora leading to an increase in intestinal cholesterol degradation, decreased plasma cholesterol and increased intestinal wellbeing. This project will provide novel preliminary data for future research studies and to develop new consumer messages on the gut health benefits of grapes. New consumer information about the health benefit of grapes will enhance the The California Table Grape industry domestic and export marketing programs and increase consumption of grapes.
- Conditions
- Healthy
- Being tested
- Table Grape Powder, Beige Diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Table Grape PowderOther
Freeze Dried Whole Table Grape Powder
Beige DietOther
Low Fiber, low polyphenol Diet
| Study group | Role | What they receive |
|---|---|---|
| Table Grape | Active comparator | Subjects will consume 4 weeks of (two servings) of standardized Freeze-Dried Whole Table Grape Powder Receives: Other: Table Grape Powder |
| Beige Diet | Placebo comparator | Subjects will consume 4 weeks of a beige diet (low in fiber and low in polyphenols) Receives: Other: Beige Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in intestinal microbiome composition
Stool samples will be collected at week 4 and 8 of the intervention periods
Measured: Baseline (week 0) to Week 8
Secondary outcomes (4)
change in fecal cholesterol, cholesterol metabolites, and bile acids
Stool samples will be collected at week 4 and 8 of the intervention periods
Measured: Baseline (week 0) to Week 8
change in blood total cholesterol, LDL and HDL-cholesterol,
Total cholesterol in blood will be analyzed spectrophotometrically using cholesterol reagent
Measured: Baseline (week 0) to Week 8
digestive Health and General Wellness questionnaires (Rand SF-36)
The Weekly Digestive Symptom Log measures gastrointestinal symptoms (gas, bloating, diarrhea, etc.) and will be completed daily by all subjects. The Rand SF-36 will be completed at baseline (week 0), and week 4 visits to report on patients' overall well-being
Measured: Baseline (week 0) to Week 8
urine content of syringic acid, and ellagic acid metabolites - ellagic acid, and dimethylellagic acid glucuronide
as biomarkers for compliance
Measured: Baseline (week 0) to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start5 Oct 2020
- Primary completion6 Mar 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This will be a two phase intervention study.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- The California Table grape Commission
- Responsible party
- Principal investigator, Zhaoping Li, University of California, Los Angeles
- Investigators
- Zhaoping Li, MD, PhD, Principal investigator, UCLA Center for Human Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05025189
- Sponsor's protocol ID
- 18-001635
- Status last verified
- May 2023
- First submitted
- 24 Aug 2021
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Grape Consumption on the Microbiome in Healthy Subjects: A Pilot Study
- ClinicalTrials.gov ID
- NCT05025189
- Acronym / sponsor ID
- 18-001635
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- The California Table grape Commission
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- 6 Mar 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 27 Aug 2021 (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.
This pilot study will assess the ability of daily consumption of one dose (2 servings) of freeze-dried whole table grape powder, made from conventionally grown grapes to alter the composition of the bacteria that live in the intestines in healthy subjects. The grape powder contains 46g of individually quick frozen (IQF) grapes, which is equivalent to 252g fresh fruit. 20 subjects will will consume the beige diet for 4 weeks followed by one dose (two servings) of standardized Freeze-Dried Whole Table Grape Powder (46g) daily for 4 weeks. The primary objective of this pilot study is to determine changes in the gut microbiome. Stool samples will be collected at 4 and 8 weeks for bacterial DNA to determine changes in the bacteria that live in the intestines. You will be asked to avoid foods rich in polyphenols including dark chocolate and cocoa products, dried herbs, berries, coffee, tea, flaxseeds, nuts (chestnut, hazelnut), olive and artichoke for the duration of the study.
Detailed description
The bacterial composition of the intestinal microbiome has been linked to the development of chronic diseases including obesity, metabolic syndrome, type II diabetes and heart disease. Grapes provide a rich source of polyphenols and fiber. It has been demonstrated in animal studies that fruits with high polyphenol content and fiber exhibit prebiotic effects leading to changes in the gut microbiome, decrease in symptoms of metabolic syndrome, improvement in insulin resistance and decrease in intestinal and systemic inflammation. Several human intervention studies have also been performed that demonstrated beneficial effects of high polyphenol fruits on the intestinal microbiome. No information is available about the effect of grape consumption on the gut microbiome. This proposed pilot study will assess the ability of consumption of two servings of grapes daily to alter the gut microbiome composition, leading to increased bile secretion, increased fecal cholesterol degradation/excretion, decreased plasma cholesterol and improved intestinal wellbeing in a free-living population. 20 subjects will consume the beige diet for 4 weeks followed by one dose (two servings) of standardized Freeze-Dried Whole Table Grape Powder (46g) daily for 4 weeks. The primary objective of this pilot study is to determine changes in the gut microbiome. Secondary outcome will be fecal bile and cholesterol and their metabolites, plasma cholesterol and intestinal wellbeing questionnaire at 4 and 8 weeks Stool samples will be collected at 4 and 8 weeks for sequencing of bacterial DNA to determine changes in the microbiota. Changes in fecal bile, cholesterol, and cholesterol metabolites will be analyzed by gas chromatography. The objective of the proposed pilot study is to determine whether intake of 2 servings of grapes per day will alter the intestinal microflora leading to an increase in intestinal cholesterol degradation, decreased plasma cholesterol and increased intestinal wellbeing. This project will provide novel preliminary data for future research studies and to develop new consumer messages on the gut health benefits of grapes. New consumer information about the health benefit of grapes will enhance the The California Table Grape industry domestic and export marketing programs and increase consumption of grapes.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This will be a two phase intervention study.
| Arm | Type | Receives |
|---|---|---|
| Table Grape | Active comparator | Other: Table Grape PowderSubjects will consume 4 weeks of (two servings) of standardized Freeze-Dried Whole Table Grape Powder |
| Beige Diet | Placebo comparator | Other: Beige DietSubjects will consume 4 weeks of a beige diet (low in fiber and low in polyphenols) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy human adults age 18-55 years old (females have to be premenopausal)
- Typically consume low fiber/polyphenol diet (beige diet)
Key exclusion criteria (10 listed)
- Eating a high fiber/polyphenol diet or taking any medication or dietary supplement, which interfere with the absorption of polyphenols.
- History of gastrointestinal surgery, diabetes mellitus on medications, or other serious medical condition, such as chronic hepatic or renal disease, bleeding disorder, congestive heart disease, chronic diarrhea disorders, myocardial infarction, coronary artery bypass graft, angioplasty within 6 months prior to screening, current diagnosis of uncontrolled hypertension (defined as systolic BP >160mmHg, diastolic BP > 95mmHg), active or chronic gastrointestinal disorders, bulimia, anorexia, laxative abuse, or endocrine diseases (except thyroid disease requiring medication) as indicated by medical history or routine physical examination.
- Screening laboratory value outside of the laboratory normal range that is considered clinically significant for study participation by the investigator.
- Is unable or unwilling to comply with the study protocol.
- Using prebiotics, probiotics, yogurt, and/or any fiber supplements regularly
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 |
|---|---|---|
| Table Grape PowderFreeze Dried Whole Table Grape Powder | Other | Table Grape |
| Beige DietLow Fiber, low polyphenol Diet | Other | Beige Diet |
Primary outcome
Change in intestinal microbiome composition
Time frame: Baseline (week 0) to Week 8
Stool samples will be collected at week 4 and 8 of the intervention periods
4 secondary outcomes
change in fecal cholesterol, cholesterol metabolites, and bile acids
Time frame: Baseline (week 0) to Week 8
change in blood total cholesterol, LDL and HDL-cholesterol,
Time frame: Baseline (week 0) to Week 8
digestive Health and General Wellness questionnaires (Rand SF-36)
Time frame: Baseline (week 0) to Week 8
urine content of syringic acid, and ellagic acid metabolites - ellagic acid, and dimethylellagic acid glucuronide
Time frame: Baseline (week 0) to Week 8
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 6 May 2023.
- Individual participant dataSharing planned: No
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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.
Zhaoping Li, MD, PhD principal investigator
UCLA Center for Human Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Table Grape Powder and Beige Diet in people with Healthy, run by University of California, Los Angeles 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 2 inclusion and 10 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 6 May 2023. 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?
Change in intestinal microbiome composition (time frame: Baseline (week 0) to Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2023.