NCT01495182

Brief Summary

The purpose of the study will be to assess the gastrointestinal effects of a dietary fiber in healthy, adult volunteers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

December 14, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 19, 2011

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

April 21, 2016

Status Verified

December 1, 2011

Enrollment Period

1 year

First QC Date

December 14, 2011

Last Update Submit

April 20, 2016

Conditions

Gastrointestinal Health

Keywords

Dietary fiberGastrointestinal tolerationFecal weight

Outcome Measures

Primary Outcomes (1)

  • Gastrointestinal tolerability

    Questionnaire to assess symptoms such as nausea, bloating, and flatulence

    subjects will report weekly for 6 weeks

Secondary Outcomes (1)

  • Fecal output

    subjects will collect fecal output for 12 days within a six-week period

Study Arms (3)

Dietary Fiber - Dose 1

EXPERIMENTAL

Dietary fiber will be added to study foods

Other: Dietary fiber

Dietary Fiber - Dose 2

EXPERIMENTAL

Dietary fiber will be added to study foods

Other: Dietary fiber

Control

ACTIVE COMPARATOR

Study foods with no added fiber will be given

Other: Dietary fiber

Interventions

Dietary fiberOTHER

A proprietary fiber will be given to subjects

ControlDietary Fiber - Dose 1Dietary Fiber - Dose 2

Eligibility Criteria

Age18 Years - 54 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy men and women
  • age 18 - 54 years
  • BMI \< 30 kg/m2

You may not qualify if:

  • presence of GI or other serious diseases known to affect GI function
  • recent use of antibiotics
  • very high fiber intake
  • use of medications known to affect GI function
  • presence of allergies to study foods

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Provident Clinical Research and Consulting Inc

Glen Ellyn, Illinois, 60137, United States

Location

MeSH Terms

Interventions

Dietary Fiber

Intervention Hierarchy (Ancestors)

Dietary CarbohydratesCarbohydratesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Kevin Maki, PhD

    Provident Clinical Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2011

First Posted

December 19, 2011

Study Start

December 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

April 21, 2016

Record last verified: 2011-12

Locations

US(1)