Prebiotic Effects of a Polyphenol-rich Food Product | NCT03659240

Studies
Prebiotic Effects of a Polyphenol-rich Food Product

NCT03659240

Sponsor

Iowa State University

Status

Completed

Last Update Posted

Mar 2, 2023Actual

Enrollment

25Actual

Phase

Not Applicable

Conditions

Dysbiosis

Interventions

Cranberry beverage
Placebo beverage

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

Feb 2023

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

Oct 9, 2018Actual

Primary Completion Date

Feb 24, 2019Actual

Completion Date

Feb 24, 2019Actual

First Submitted Date

Sep 3, 2018

First Submission Date that Met QC Criteria

Sep 3, 2018

First Posted Date

Sep 6, 2018Actual

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

Feb 28, 2023

Last Update Posted Date

Mar 2, 2023Actual

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

The specific aim for this project will be to investigate a cranberry beverage as a means to restore balance in terms of the relative proportions of the various bacteria that inhabit the large intestine.

Detailed Description

Not provided

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

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cranberry beverage	Experimental		Other: Cranberry beverage
Placebo beverage	Placebo Comparator		Other: Placebo beverage

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cranberry beverage	Other	During the intervention period, research participants will consume a cranberry beverage daily.	Cranberry beverage

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fecal microbial community composition and structure	We will investigate if specific bacterial taxa are stimulated by daily consumption of a cranberry beverage.	Changes in the fecal microbiota will be measured after a 20-day intervention period

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

BMI 27-35 kg/m2
High waist circumference (men >102 cm and women >88 cm)

Exclusion Criteria:

Cigarette smoking
Regular intensive exercise
Pregnancy or lactation
Chronic diarrhea, constipation, or other gastrointestinal complaint
Diabetes mellitus, autoimmune disease, or other chronic disease known to alter the gut microbiota
Use of medications that affect inflammation or the gut microbiota
Use of prebiotics, probiotics, synbiotics, vitamins, or other dietary supplements known to affect the gut microbiota
Aversion to cranberries
Food allergies
Lactose intolerance
Vegetarianism

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nutrition and Wellness Research Center		Ames	Iowa	50011	United States

Condition Browse Module

MeSH Terms

ID	Term
D064806	Dysbiosis

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided