Acute Gastrointestinal Tolerability Following a Single Serving of a Novel Dietary Fiber
Condition: Signs and Symptoms, Digestive
MeSH terms: Signs and Symptoms, Digestive
Study type: Interventional

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.
    

Intervention name(s): Novel Fiber; Positive Fiber control; Negative Control
Intervention type(s): Other; Other; Other
Intervention description(s): novel fiber supplemented beverage provided in one serving; positive control fiber supplemented beverage provided in one serving; No added fiber beverage
Other intervention name(s): Cba-1; Polydextrose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Gastrointestinal tolerability; dietary fiber; clinical trial; healthy subjects