Effects of Adding Raisins to the American Diet on Fecal Microbiota Composition
Primary Purpose
Inflammation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Raisins
Sponsored by

About this trial
This is an interventional other trial for Inflammation focused on measuring Gut Microbiota
Eligibility 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
Sites / Locations
- Emerging Pathogens Institiute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Raisins Enhanced Diet
Arm Description
Participants will be provide with a Raisin Enhanced Diet over a short term period of time.
Outcomes
Primary Outcome Measures
Changes in diversity of gut microbiota 16S rRNA gene sequences with regard to time.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02713165
First Posted
March 15, 2016
Last Updated
September 7, 2017
Sponsor
University of Florida
Collaborators
Sun-Maid Growers of California
1. Study Identification
Unique Protocol Identification Number
NCT02713165
Brief Title
Effects of Adding Raisins to the American Diet on Fecal Microbiota Composition
Official Title
Effects of Adding Raisins to the American Diet on Fecal Microbiota Composition
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
Sun-Maid Growers of California
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation
Keywords
Gut Microbiota
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Raisins Enhanced Diet
Arm Type
Experimental
Arm Description
Participants will be provide with a Raisin Enhanced Diet over a short term period of time.
Intervention Type
Other
Intervention Name(s)
Raisins
Other Intervention Name(s)
Sun-Maid California Raisins
Intervention Description
Participants will consume 84g of raisins per day for 14 days.
Primary Outcome Measure Information:
Title
Changes in diversity of gut microbiota 16S rRNA gene sequences with regard to time.
Description
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.
Time Frame
Change in Baseline (Day 1), Day 9, and Day 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Volker Mai, PhD, MPH
Organizational Affiliation
Associate Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emerging Pathogens Institiute
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30845997
Citation
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.
Results Reference
derived
Learn more about this trial
Effects of Adding Raisins to the American Diet on Fecal Microbiota Composition
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