The Effect of Grape Consumption on Increasing the Good Bacteria in the Human Intestine

NCT05025189 | Completed

• 1 other identifier: 18-001635
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Change in intestinal microbiome composition

  Stool samples will be collected at week 4 and 8 of the intervention periods

  Baseline (week 0) to Week 8

Secondary Outcomes (4)

• change in fecal cholesterol, cholesterol metabolites, and bile acids

  Baseline (week 0) to Week 8

• change in blood total cholesterol, LDL and HDL-cholesterol,

  Baseline (week 0) to Week 8

• digestive Health and General Wellness questionnaires (Rand SF-36)

  Baseline (week 0) to Week 8

• urine content of syringic acid, and ellagic acid metabolites - ellagic acid, and dimethylellagic acid glucuronide

  Baseline (week 0) to Week 8

Study Arms (2)

Table Grape

ACTIVE COMPARATOR

Subjects will consume 4 weeks of (two servings) of standardized Freeze-Dried Whole Table Grape Powder

Other: Table Grape Powder

Beige Diet

PLACEBO COMPARATOR

Subjects will consume 4 weeks of a beige diet (low in fiber and low in polyphenols)

Other: Beige Diet

Interventions

Table Grape Powder OTHER

Freeze Dried Whole Table Grape Powder

Table Grape

Beige Diet OTHER

Low Fiber, low polyphenol Diet

Beige Diet

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• The California Table grape Commission: collaborator

Study Sites (1)

UCLA Center for Human Nutrition

Los Angeles, California, 90024, United States

Location

Study Officials

• Zhaoping Li, MD, PhD

  UCLA Center for Human Nutrition

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of Clinical Nutrition

Model Details: This will be a two phase intervention study.

Study Record Dates

• First Submitted: August 24, 2021
• First Posted: August 27, 2021
• Study Start: October 5, 2020
• Primary Completion: March 6, 2021
• Study Completion: July 30, 2021
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)