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

Brief Summary

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.

Primary Outcomes