Effects of Adding Raisins to the American Diet on Fecal Microbiota Composition
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|ClinicalTrials.gov Identifier: NCT02713165|
Recruitment Status : Completed
First Posted : March 18, 2016
Last Update Posted : September 11, 2017
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Raisins Enhanced Diet
Participants will be provide with a Raisin Enhanced Diet over a short term period of time.
Participants will consume 84g of raisins per day for 14 days.
Other Name: Sun-Maid California Raisins
- 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.
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
|United States, Florida|
|Emerging Pathogens Institiute|
|Gainesville, Florida, United States, 32608|
|Principal Investigator:||Volker Mai, PhD, MPH||Associate Professor|