Gastrointestinal Toleration of Inulin Products

University of Minnesota (UMN)

Status: Completed

Conditions: Healthy

Treatments: Dietary Supplement: Inulin Fiber Supplement

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00958529

0805M32121

Details and patient eligibility

About

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.

Full description

0, 5, and 10 grams of inulin

Enrollment: 26 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

inulin

Experimental group

Description:

0, 5, 10 g inulin

Treatment:

Dietary Supplement: Inulin Fiber Supplement