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

Sponsor
University of Florida (Other)
Overall Status
Completed
CT.gov ID
NCT02713165
Collaborator
Sun-Maid Growers of California (Other)
18
Enrollment
1
Location
1
Arm
5
Duration (Months)
3.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Raisins
 N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
18 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Effects of Adding Raisins to the American Diet on Fecal Microbiota Composition
Study Start Date :
Jan 1, 2016
Actual Primary Completion Date :
May 1, 2016
Actual Study Completion Date :
Jun 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Raisins Enhanced Diet

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

Other: Raisins
Participants will consume 84g of raisins per day for 14 days.
Other Names:
  • Sun-Maid California Raisins

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Changes in diversity of gut microbiota 16S rRNA gene sequences with regard to time. [Change in Baseline (Day 1), Day 9, and Day 14]

      Compare the overall gut microbial diversity of individual subjects before and after the implementation of a controlled and observed diet of raisins, using 16S ribosomal RNA (rRNA) sequencing of fecal samples.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Emerging Pathogens Institiute Gainesville Florida United States 32608

    Sponsors and Collaborators

    • University of Florida
    • Sun-Maid Growers of California

    Investigators

    • Principal Investigator: Volker Mai, PhD, MPH, Associate Professor

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Florida
    ClinicalTrials.gov Identifier:
    NCT02713165
    Other Study ID Numbers:
    • IRB201500607
    First Posted:
    Mar 18, 2016
    Last Update Posted:
    Sep 11, 2017
    Last Verified:
    Sep 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Florida
    Gut Microbiota
    Additional relevant MeSH terms:
    Inflammation

    Study Results

    No Results Posted as of Sep 11, 2017