NCT00958529

Brief Summary

The intake of inulin products has been linked to multiple health benefits which has lead to inulin fortification in food products. The investigators hypothesis that doses of up to 10 grams of inulin products should be well tolerated and not result in a significant increase in gastrointestinal symptoms.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Aug 2008

Shorter than P25 for not_applicable healthy

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

August 1, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 13, 2009

Completed
Last Updated

February 10, 2017

Status Verified

February 1, 2017

Enrollment Period

2 months

First QC Date

August 12, 2009

Last Update Submit

February 9, 2017

Conditions

Healthy

Keywords

fiberinulingastrointestinal tolerance

Outcome Measures

Primary Outcomes (1)

  • Gastrointestinal Tolerance Score

    Aug 2008 thru Oct 2008

Study Arms (1)

inulin

EXPERIMENTAL

0, 5, 10 g inulin

Dietary Supplement: Inulin Fiber Supplement

Interventions

Inulin Fiber SupplementDIETARY_SUPPLEMENT

Orange juice fortified with 0, 5g, and 10g of 2 inulin products

inulin

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • english speaking
  • healthy men and women
  • and 60 years of age
  • non-smoking
  • non-dieting
  • BMI less than 30
  • standard diet consisting of no more than 15 grams fiber
  • not taking medications

You may not qualify if:

  • BMI more than 30
  • CVD
  • Diabetes Mellitus
  • cancer in prior 5 years
  • renal or hepatic disease
  • bacterial infection in past 2 weeks
  • more than 5 kg weight loss in past 3 months
  • history of drug or alcohol abuse in past 6 months
  • use of weight loss, lipid-lowering, anti-hypertensive, or anti- inflammatory medications
  • concurrent or recent intervention study participation
  • consumption of laxatives
  • history of gastrointestinal disorders
  • food allergies
  • pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota: Nutrition and Food Science Department

Minneapolis, Minnesota, 55108, United States

Location

Study Officials

  • Joanne L Slavin, PhD

    University of Minnesota

    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

August 12, 2009

First Posted

August 13, 2009

Study Start

August 1, 2008

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

February 10, 2017

Record last verified: 2017-02

Locations

US(1)