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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02713165
Enrollment
18
Registered
2016-03-18
Start date
2016-01-31
Completion date
2016-06-30
Last updated
2017-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammation

Keywords

Gut Microbiota

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.

Interventions

OTHERRaisins

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

Sponsors

Sun-Maid Growers of California
CollaboratorUNKNOWN
University of Florida
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in diversity of gut microbiota 16S rRNA gene sequences with regard to time.Change in Baseline (Day 1), Day 9, and Day 14Compare 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026