Gastrointestinal Tolerability Following Multiple Servings of a Novel Dietary Fiber

NCT02532985 | Completed DMC

• 1 other identifier: BIO-1411
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Signs and Symptoms, Digestive

Keywords

Gastrointestinal tolerability; dietary fiber; clinical trial; healthy subjects

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (5)

Negative control

PLACEBO COMPARATOR

No added fiber

Other: Negative Control

Positive fiber control

ACTIVE COMPARATOR

90g positive control fiber

Other: Positive Fiber Control

Novel fiber 30g

EXPERIMENTAL

30g novel fiber

Other: Novel Fiber

Novel fiber 60g

EXPERIMENTAL

60g novel fiber

Other: Novel Fiber

Novel fiber 90g

EXPERIMENTAL

90g novel fiber

Other: Novel Fiber

Interventions

Negative Control OTHER

No added fiber beverage

Negative control

Positive Fiber Control OTHER

positive control fiber supplemented beverage provided over 4 servings

Also known as: Polydextrose

Positive fiber control

Novel Fiber OTHER

novel fiber supplemented beverage provided over 4 servings

Also known as: Cba-1

Novel fiber 30g

Eligibility Criteria

• Age: 18 Years - 54 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subject is male or female, 18-54 years of age, inclusive.
• Subject has body mass index (BMI) ≥18.50 and ≤39.99 kg/m2 at visit 1 (day -7) and has been weight stable (± 4.5 kg) for the previous 3 months.
• Subject is judged to be in good health on the basis of medical history.
• Subject is willing to maintain his or her habitual diet and physical activity patterns, including habitual use of study approved medications and/or dietary supplements throughout the study period.
• Subject is willing to avoid foods/beverages that cause GI-distress, as well as high-fiber foods for 24 h prior to test visits.
• Subject understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigators.

You may not qualify if:

• Subject reports any clinically important GI condition that would potentially interfere with the evaluation of the study product (e.g., inflammatory bowel disease, irritable bowel syndrome, history of surgery for weight loss, gastroparesis, and clinically important lactose intolerance).
• History or presence of clinically important endocrine (including type 1 or 2 diabetes mellitus), cardiovascular, pulmonary, biliary, renal, hepatic, pancreatic, or neurologic disorders that, in the opinion of the Investigator, could interfere with the interpretation of the study results.
• Recent history (within 6 weeks of screening, visit 1) of constipation (defined as \<3 bowel movements per week), and/or diarrhea (defined as ≥3 loose or liquid stools/d).
• Recent (within 6 weeks of screening, visit 1) episode of acute GI illness such as nausea, vomiting or diarrhea.
• Daily use of non-steroidal anti-inflammatory drugs (NSAIDS),
• Daily use of antacids, proton pump inhibitors, and/or H2 blockers.
• Recent use of antibiotics (within 3 months of visit 2, day 0).
• Use of medications (over-the-counter and prescription) or dietary supplements (within 3 weeks of visit 2, day 0) known to influence GI function such as constipation medications and supplements (including laxatives, enemas, fiber supplements and/or suppositories); anti-diarrheal agents; anti-spasmodic; prebiotic and probiotic supplements.
• Extreme dietary habits, including but not limited to vegetarian diets and intentional consumption of a high fiber diet.
• Known allergy or sensitivity to food ingredients such as: soy, dairy (milk), wheat, egg, peanuts, tree nuts, fin fish and crustacean.
• Uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg at visit 1, day -7).
• History of cancer in the prior two years, except for non-melanoma skin cancer.
• Any major trauma or surgical event within 2 months of visit 2, day 0.
• Females who are pregnant, planning to be pregnant during the study period, lactating, or women of childbearing potential who were unwilling to commit to use of a medically approved form of contraception throughout the study period.
• Exposure to any non-registered drug product within 30 days previous to the screening visit.

Sponsors & Collaborators

• Cargill: lead

MeSH Terms

Conditions

Signs and Symptoms, Digestive

Interventions

polydextrose

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2015
• First Posted: August 26, 2015
• Study Start: October 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: May 1, 2015
• Last Updated: August 26, 2015

Record last verified: 2015-08