Clinical trial NCT05025189: The Effect of Grape Consumption on Increasing the Good Bacteria in the Human Intestine
Official title: Effect of Grape Consumption on the Microbiome in Healthy Subjects: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: The California Table grape Commission
First posted: 2021-08-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This will be a two phase intervention study.
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Healthy human adults age 18-55 years old (females have to be premenopausal)
* Typically consume low fiber/polyphenol diet (beige diet)

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Change in intestinal microbiome composition
timeFrame: Baseline (week 0) to Week 8
Secondary outcomes:
measure: change in fecal cholesterol, cholesterol metabolites, and bile acids
timeFrame: Baseline (week 0) to Week 8
measure: change in blood total cholesterol, LDL and HDL-cholesterol,
timeFrame: Baseline (week 0) to Week 8
measure: digestive Health and General Wellness questionnaires (Rand SF-36)
timeFrame: Baseline (week 0) to Week 8
measure: urine content of syringic acid, and ellagic acid metabolites - ellagic acid, and dimethylellagic acid glucuronide
timeFrame: Baseline (week 0) to Week 8
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Center for Human Nutrition
state: California
Study officials:
affiliation: UCLA Center for Human Nutrition
name: Zhaoping Li, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: