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

NCT02713165 | Completed

• 1 other identifier: IRB201500607
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammation

Keywords

Gut Microbiota

Outcome Measures

Primary Outcomes (1)

• 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.

  Change in Baseline (Day 1), Day 9, and Day 14

Study Arms (1)

Raisins Enhanced Diet

EXPERIMENTAL

Participants will be provide with a Raisin Enhanced Diet over a short term period of time.

Other: Raisins

Interventions

Raisins OTHER

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

Also known as: Sun-Maid California Raisins

Raisins Enhanced Diet

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• Sun-Maid Growers of California: collaborator

Study Sites (1)

Emerging Pathogens Institiute

Gainesville, Florida, 32608, United States

Location

Related Publications (1)

• 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.

  PMID: 30845997 DERIVED

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Volker Mai, PhD, MPH

  Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2016
• First Posted: March 18, 2016
• Study Start: January 1, 2016
• Primary Completion: May 1, 2016
• Study Completion: June 1, 2016
• Last Updated: September 11, 2017

Record last verified: 2017-09

Locations

US (1)