NCT02532985

Gastrointestinal Tolerability Following Multiple Servings of a Novel Dietary Fiber

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 Women

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Cargill · Industry
• Sex: All
• Age: 18 Years – 54 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a randomized, double-blind, five test periods crossover study consisting of a screening visit (visit 1, day -7) and 10 test visits (days 0, 2, 7, 9, 14, 16, 21, 23, 28, 30). At the screening visit, after subjects have provided informed consent, medical history and clinic visit procedures will be performed. Subjects who meet the study criteria will be instructed to maintain habitual diet and physical activity patterns throughout the study period. Subjects will also be instructed to avoid foods/ beverages that cause Gastrointestinal (GI)-distress, as well as high-fiber foods for the 24 h prior to and throughout each 48 h test period. Additional instructions will include avoiding the use of non-steroidal anti-inflammatory drugs (NSAIDS), antacids, proton pump inhibitors (PPIs), and H2 receptor antagonists for the 48 h prior to the next clinic visit (visit 2, day 0). At the test visits, eligible subjects will undergo clinic visit procedures, including assessment of adverse events (AEs). At the beginning of each test period (Visits 2, 4, 6, 8, and 10), subjects will arrive at the clinic after a 9-14 h fast and will be administered one serving of their assigned study product to consume within 15 min with a standard breakfast meal (t = 0 h). Subjects will remain in the clinic and will be provided a second serving of their assigned study product to consume within 15 min with a standard lunch meal at t= 4 ± 0.5 h. Subjects will then be provided the third and fourth servings of their assigned study product and instructed to consume the study product in its entirety within 15 min of their also provided afternoon snack, and evening dinner, respectively, and to allow at least 3 h between eating occasions. Compliance with dispensed product and meal consumption will be confirmed with a diet record. Subjects will be also instructed to complete a GI Tolerability Questionnaire the next morning (t=24h) after an overnight fast (9-14h). A Bowel Habits Diary will be completed from the initial study product consumption (t= 0) until the subsequent clinic visit (t= 48 h). Subjects will return to the clinic at t= 48 h (Visits 3, 5, 7, 9, and 11) after an overnight fast (9-14 h) to complete the test period, at which time a 48 h GI Tolerability Questionnaire will also be completed. A washout period of 7 d will occur between each test period (e.g., before Visits 4, 6, 8, and 10), after which subjects will return to the clinic to cross over to the next study product in their test sequence.

Conditions

• Signs and Symptoms, Digestive

Interventions

Type	Name	Description
OTHER	Negative Control	No added fiber beverage
OTHER	Positive Fiber Control	positive control fiber supplemented beverage provided over 4 servings
OTHER	Novel Fiber	novel fiber supplemented beverage provided over 4 servings
OTHER	Novel Fiber	novel fiber supplemented beverage provided over 4 servings
OTHER	Novel Fiber	novel fiber supplemented beverage provided over 4 servings

Timeline

• Start date: 2014-10-01
• Primary completion: 2015-03-01
• Completion: 2015-05-01
• First posted: 2015-08-26
• Last updated: 2015-08-26