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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02713165
Recruitment Status : Completed
First Posted : March 18, 2016
Last Update Posted : September 11, 2017
Sponsor:
Collaborator:
Sun-Maid Growers of California
Information provided by (Responsible Party):
University of Florida

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
Inflammation Other: Raisins Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : January 2016
Actual Primary Completion Date : May 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

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 Name: Sun-Maid California Raisins




Primary Outcome Measures :
  1. Changes in diversity of gut microbiota 16S rRNA gene sequences with regard to time. [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02713165


Locations
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United States, Florida
Emerging Pathogens Institiute
Gainesville, Florida, United States, 32608
Sponsors and Collaborators
University of Florida
Sun-Maid Growers of California
Investigators
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Principal Investigator: Volker Mai, PhD, MPH Associate Professor
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02713165    
Other Study ID Numbers: IRB201500607
First Posted: March 18, 2016    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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Inflammation
Pathologic Processes