Effect of Strawberry Consumption on the Microbiome

NCT04217122 | Completed

• 1 other identifier: IRB#18-000312
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study will assess the ability of daily consumption of two servings of California strawberries to alter gut microbiome composition, leading to increased bile secretion and decreased plasma cholesterol in a free-living population.

Conditions

Microbiome

Keywords

Strawberry; polyphenols; cholesterol

Outcome Measures

Primary Outcomes (1)

• Change in microbiome composition

  Change in phyla, genes and species of gut bacteria

  4 weeks

Study Arms (2)

Strawberry intervention group

EXPERIMENTAL

Participants consume two packages of 13 g of standard strawberry powder in the morning and afternoon/evening per day for 4 weeks

Other: strawberry powder

Placebo group

PLACEBO COMPARATOR

Participants consume two packages of 13 grams placebo powder in the morning and afternoon/evening for 4 weeks.

Other: placebo powder

Interventions

strawberry powder OTHER

Participants consume 2 packages of standard strawberry powder (13 g x 2) daily for 4 weeks

Strawberry intervention group

placebo powder OTHER

Participants consume 2 packages of placebo powder (13 g x 2) daily for 4 weeks

Placebo group

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 known HIV positive (subjects who are HIV positive are known to have high evels of LDL cholesterol and generalized heart inflammation).
• Is unable or unwilling to comply with the study protocol.
• Using prebiotics, probiotics, yogurt, and/or any fiber supplements regularly
• Allergy or sensitivity to strawberries. 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 strawberry ingestion without incident will be requested. In addition, any subject with a history of allergy or anaphylaxis of any kind will be excluded.
• Taking antibiotics or laxatives within the past 3 months
• Any subject who demonstrate a risk of non-compliance with study procedure, or one who cannot read, understand or complete study - related materials in the opinion of the study investigator.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Center for Human Nutrition, 1000 Veteran Ave.

Los Angeles, California, 90095, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 30, 2019
• First Posted: January 3, 2020
• Study Start: September 11, 2018
• Primary Completion: February 21, 2019
• Study Completion: December 19, 2019
• Last Updated: January 7, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)