NCT02530762

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

A Randomized, Double-Blind, Crossover Study to Assess the Acute Gastrointestinal Tolerability Following a Single Serving of Cba-1, a Novel Dietary Fiber, 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 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.

Detailed description

This is a randomized, double-blind, crossover study consisting of one screening visit (visit 1, day -7) and 10 test visits (days 0, 1, 7, 8, 14, 15, 21, 22, 28, 29). At the screening visit (visit 1, day -7), after subjects have provided informed consent, medical history and clinic visit procedures will be performed. Subjects who meet initial study inclusion/exclusion 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 24 h prior to the next clinic visit (visit 2, day 0). Additional instructions will include avoiding use of non-steroidal anti-inflammatory drugs (NSAIDS), antacids, proton pump inhibitors (PPIs), and H2 receptor antagonists for 24 h prior to the next clinic visit (visit 2, day 0). At visit 2 (day 0), eligible subjects will return to the clinic following an overnight fast (9-14 h) to undergo clinic visit procedures. Adverse events (AEs) will also be assessed. Eligible subjects will then be randomly assigned to a test sequence wherein five test periods will be completed in a crossover design. Subjects will be administered one serving of their assigned study product to be consumed in-clinic. Subjects will be instructed to consume the study product in its entirety within 15 min with a standard breakfast. Subjects will be dispensed a daily Bowel Habits Diary, which includes the Bristol Stool Scale, to record the frequency and consistency of bowel movements over the following 24 h (t = 0 is the time of study product consumption). Subjects will also be dispensed a 1-day diet record to record all foods/beverages consumed. Subjects will be instructed to record all foods/beverages for the following 24 h, beginning with study product consumption (t = 0 h). Subjects will be dismissed from the clinic with instructions to avoid foods/ beverages that cause GI-distress, as well as high-fiber foods, and to avoid use of non-steroidal anti-inflammatory drugs (NSAIDS), antacids, proton pump inhibitors (PPIs), and H2 receptor antagonists for the following 24 h until the next clinic visit (visit 3, day 1). At visit 3 (day 1), subjects will arrive at the clinic 24 h after study product consumption following an overnight fast (9-14 h). Concomitant medication/supplement use, review of inclusion/exclusion, AEs will be assessed and subjects will complete a GI Tolerability Questionnaire. Subjects will also return their 1-day diet records and Bowel Habits Diary; this visit will be scheduled to ensure the entire 24 h period following study product consumption (t = 0 h) is captured. Prior to being dismissed from the clinic, subjects will be reminded of subsequent study visit instructions, including: fasting compliance (9-14 h, water only); maintenance of usual dietary and physical activity practices; avoiding use of non-steroidal anti-inflammatory drugs (NSAIDS), antacids, proton pump inhibitors (PPIs), and H2 receptor antagonists for 24 h prior to the next clinic visit (visit 4, day 7); and avoidance of foods/beverages that may cause GI distress, as well as high-fiber foods for 24 h prior to, and for the duration of the subsequent test visit (visit 4, day 7)\]. Visit 2 procedures will be replicated at visits 4, 6, 8, and 10, which will be separated by a washout period of 7 ± 3 days. In addition, each subject will receive a copy of his or her 1-Day Diet Record from the first test visit (visit 2) and will be asked to replicate, as closely as possible, consumption of the same foods and to avoid foods/ beverages that cause GI-distress, as well as high-fiber foods. Visit 3 procedures will be replicated at visits 5, 7, 9, and 11.

Conditions

• Signs and Symptoms, Digestive

Interventions

Type	Name	Description
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

Timeline

• Start date: 2014-09-01
• Primary completion: 2014-12-01
• Completion: 2015-03-01
• First posted: 2015-08-21
• Last updated: 2015-08-21