Effects of Adding Raisins to the American Diet on Fecal M... | NCT02713165

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

NCT02713165

Sponsor

University of Florida

Status

Completed

Last Update Posted

Sep 11, 2017Actual

Enrollment

18Actual

Phase

Not Applicable

Conditions

Inflammation

Interventions

Raisins

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2016

Primary Completion Date

May 2016Actual

Completion Date

Jun 2016Actual

First Submitted Date

Mar 15, 2016

First Submission Date that Met QC Criteria

Mar 15, 2016

First Posted Date

Mar 18, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 7, 2017

Last Update Posted Date

Sep 11, 2017Actual

Name	Class
Sun-Maid Growers of California	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Raisins Enhanced Diet	Experimental	Participants will be provide with a Raisin Enhanced Diet over a short term period of time.	Other: Raisins

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Raisins	Other	Participants will consume 84g of raisins per day for 14 days.	Raisins Enhanced Diet

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Volker Mai, PhD, MPH	Associate Professor	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Emerging Pathogens Institiute		Gainesville	Florida	32608	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30845997	Derived	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.

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms