Gastrointestinal Tolerability Following Multiple Servings 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 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.
    

Intervention name(s): Negative Control; Positive Fiber Control; Novel Fiber; Novel Fiber; Novel Fiber
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): No added fiber beverage; positive control fiber supplemented beverage provided over 4 servings; novel fiber supplemented beverage provided over 4 servings; novel fiber supplemented beverage provided over 4 servings; novel fiber supplemented beverage provided over 4 servings
Other intervention name(s): Polydextrose; Cba-1; Cba-1; Cba-1
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Gastrointestinal tolerability; dietary fiber; clinical trial; healthy subjects