Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Negative control | Placebo Comparator | No added fiber |
|
| Positive fiber control | Active Comparator | 90g positive control fiber |
|
| Novel fiber 30g | Experimental | 30g novel fiber |
|
| Novel fiber 60g | Experimental | 60g novel fiber |
|
| Novel fiber 90g | Experimental | 90g novel fiber |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Negative Control | Other | No added fiber beverage |
| |
| Positive Fiber Control |
| Measure | Description | Time Frame |
|---|---|---|
| Composite Gastrointestinal GI Symptom Score among conditions | Composite score will be calculated for each intake level as the sum of the ratings of the individual components (abdominal distention/bloating, gas/flatulence, borborygmus/stomach rumbling, and abdominal cramping). The ratings will be coded using a 4-point scale, in which 1 = none, 2 = mild, 3 = moderate, and 4 = severe. | 24 hours |
| Composite Gastrointestinal GI Symptom Score among conditions | Composite score will be calculated for each intake level as the sum of the ratings of the individual components (abdominal distention/bloating, gas/flatulence, borborygmus/stomach rumbling, and abdominal cramping). The ratings will be coded using a 4-point scale, in which 1 = none, 2 = mild, 3 = moderate, and 4 = severe. | 48 hours |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C033375 | polydextrose |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Other |
positive control fiber supplemented beverage provided over 4 servings |
|
|
| Novel Fiber | Other | novel fiber supplemented beverage provided over 4 servings |
|
|
| Novel Fiber | Other | novel fiber supplemented beverage provided over 4 servings |
|
|
| Novel Fiber | Other | novel fiber supplemented beverage provided over 4 servings |
|
|