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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

Tracking Information
First Submitted Date  ICMJE March 15, 2016
First Posted Date  ICMJE March 18, 2016
Last Update Posted Date September 11, 2017
Study Start Date  ICMJE January 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Adding Raisins to the American Diet on Fecal Microbiota Composition
Official Title  ICMJE Effects of Adding Raisins to the American Diet on Fecal Microbiota Composition
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Inflammation
Intervention  ICMJE Other: Raisins
Participants will consume 84g of raisins per day for 14 days.
Other Name: Sun-Maid California Raisins
Study Arms  ICMJE Experimental: Raisins Enhanced Diet
Participants will be provide with a Raisin Enhanced Diet over a short term period of time.
Intervention: Other: Raisins
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 7, 2017)
18
Original Estimated Enrollment  ICMJE
 (submitted: March 15, 2016)
12
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02713165
Other Study ID Numbers  ICMJE IRB201500607
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University of Florida
Study Sponsor  ICMJE University of Florida
Collaborators  ICMJE Sun-Maid Growers of California
Investigators  ICMJE
Principal Investigator: Volker Mai, PhD, MPH Associate Professor
PRS Account University of Florida
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP