Effects of Adding Raisins to the American Diet on Fecal Microbiota Composition

NCT ID: NCT02713165

Last Updated: 2017-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-06-30

Brief Summary

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Raisins contain a significant amount of dietary fiber and polyphenolic compounds that represent an important substrate for microbiota fermentation which generates potentially beneficial end products, such as short-chain fatty acids. The mammalian gut contains a phylogenetically as well as functionally diverse microbiota that contributes to host physiology. To date, little is known about how increased raisin intake affects human gut microbiota composition.

This research study will assess the effects of adding raisins to the diet of healthy adults on the bacteria from feces of human subjects and resulting self-reported GI symptoms as well as markers of immune function. The hypothesis is that by adding raisins to the diet this will result in changes in gut microbiota. Furthermore, the changes in microbiota will largely be beneficial, as evaluated by an increase in butyrate producers and bacteria associated with anti-inflammatory properties.

Detailed Description

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The research study design is a 14 day international focus on increasing raising intake. Participants will be provided with a commercial raisin product for a 14 day period. Participants will consume 2 servings/day (84g of raisins). While participants will be told to substitute raisins for other diet ingredients, they will be free to choose what to substitute according to their preferences. Participants will keep daily food records and will be told that raisin consumption will be monitored in their fecal samples (qPCR). Fecal samples will be collected before the start (Day1), during (Day5-7) and at the end (Day 12-14) of the intervention using a stool collection kit (Sigma). Participants will complete a GI health questionnaire on a weekly basis to determine tolerance to increased raisin intake.

Conditions

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Inflammation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Raisins Enhanced Diet

Participants will be provide with a Raisin Enhanced Diet over a short term period of time.

Group Type EXPERIMENTAL

Raisins

Intervention Type OTHER

Participants will consume 84g of raisins per day for 14 days.

Interventions

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Raisins

Participants will consume 84g of raisins per day for 14 days.

Intervention Type OTHER

Other Intervention Names

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Sun-Maid California Raisins

Eligibility Criteria

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Inclusion Criteria

* Good Health
* No systemic antibiotics during the preceding two months
* No medication suppressing immune function
* Willingness to provide basic demographic as well as medical history data

Exclusion Criteria

* Gastric Ulcers
* Inflammatory Bowel Disease (IBD) or Irritable Bowel Syndrome (IBS)
* Chronic constipation/diarrhea
* Body Mass Index (BMI) \> 30
* Dietary restrictions that prevent legume intake
* Currently on any medication that can affect GI transit time
* Consumption of \>3 servings/week of raisins BEFORE study begins
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sun-Maid Growers of California

UNKNOWN

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Volker Mai, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Associate Professor

Locations

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Emerging Pathogens Institiute

Gainesville, Florida, United States

Site Status

Countries

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United States

References

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Wijayabahu AT, Waugh SG, Ukhanova M, Mai V. Dietary raisin intake has limited effect on gut microbiota composition in adult volunteers. Nutr J. 2019 Mar 7;18(1):14. doi: 10.1186/s12937-019-0439-1.

Reference Type DERIVED
PMID: 30845997 (View on PubMed)

Other Identifiers

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IRB201500607

Identifier Type: -

Identifier Source: org_study_id

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