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

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.

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Key information

Conditions

Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emerging Pathogens Institiute

Gainesville, Florida, 32608, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Raisins

Other

Participants will consume 84g of raisins per day for 14 days.

Other names: Sun-Maid California Raisins

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

Sun-Maid Growers of California

Registry information

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2016
First posted: Mar 18, 2016
Registry last updated: Sep 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed