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Acute Gastrointestinal Tolerability Following a Single Serving of a Novel Dietary Fiber

NCT02530762 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2015-08-21

No results posted yet for this study

Summary

The study will assess the gastrointestinal tolerability of a single serving of a novel dietary fiber at three different dose levels in generally healthy men and women. Double-blind controlled, cross-over clinical trial with negative (no added fiber) and positive controls. Single dose, with 24 hours data collection and 1 week wash-out between cross-overs. 45 randomized, generally healthy men and women, 18-54 y, BMI higher or equal to 18.5 and smaller or equal to 39.99 kg/m2. Novel dietary fiber ingredient and positive control will be delivered in 240 ml beverages.

Conditions

  • Signs and Symptoms, Digestive

Interventions

OTHER

Novel Fiber

novel fiber supplemented beverage provided in one serving

OTHER

Positive Fiber control

positive control fiber supplemented beverage provided in one serving

OTHER

Negative Control

No added fiber beverage

Sponsors & Collaborators

  • Cargill

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
54 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2014-12-31
Completion
2015-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02530762 on ClinicalTrials.gov