Is a
Clinical Study attributes
NCT Number
Trial Recruitment Size
450
Trial Sponsor
Clinical Trial Start Date
2014
0Primary Completion Date
2015
0Study Completion Date
2015
0Clinical Trial Study Type
Interventional0
Intervention Type
Other0
Intervention Name
Negative Control0
Positive Fiber Control0
Novel Fiber0
Interventional Trial Phase
Not Applicable0
Official Name
A Randomized, Double-Blind, Crossover Study to Assess Gastrointestinal Tolerability of Cba-1, a Novel Dietary Fiber, Using Three Dose Levels at Multiple Eating Occasions in Healthy Men and Women0
Last Updated
August 26, 2015
0Allocation Type
Randomized0
Intervention Model
Crossover Assignment0
Masking Type
Quadruple0
Masked Party
Participant0
Outcomes Assessor0
Investigator0
Care Provider0
Study summary
The study will assess the gastrointestinal tolerability of multiple servings 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. Multiple servings over 24h, with data collection at 24 and 48h 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.
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