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OpenTrials
Completed

NCT Number: NCT00958529

Gastrointestinal Toleration of Inulin Products

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.

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Key information

Conditions

Healthy

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota: Nutrition and Food Science Department

Minneapolis, Minnesota, 55108, United States

About this study

0, 5, and 10 grams of inulin

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • english speaking
  • healthy men and women
  • 18 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

Exclusion criteria

  • 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

Treatment and study plan

Inulin Fiber Supplement

Dietary Supplement

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

Primary outcomes

  1. Gastrointestinal Tolerance Score

    Time frame: Aug 2008 thru Oct 2008

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • Cargill

Registry information

Official study title

Effect of Two Doses of Inulin Products on Gastrointestinal Tolerance

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Aug 13, 2009
Registry last updated
Feb 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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