Status:
UNKNOWN
A Double Blind Study on the Gastrointestinal Effects of Arabinoxylan (Leaf Fiber Extract).
Lead Sponsor:
Comet Bio Inc.
Collaborating Sponsors:
Biofortis, Merieux NutriSciences
Conditions:
Gastrointestinal Tolerance
Eligibility:
All Genders
21-65 years
Phase:
NA
Brief Summary
The objective of this study is to investigate the effect on Arabinoxylan on gastrointestinal (GI) tolerance, bowel habits, and microbiota in adults. The study is a randomized, placebo-controlled, cros...
Detailed Description
The study is a randomized, placebo-controlled, crossover, single-center trial with one screening visit (Visit 1; Week -1) and 3 test periods \[Test Period 1 (Visits 2 and 3; Weeks 0 to 3), Test Period...
Eligibility Criteria
Inclusion
- BMI of 18.5 to 35.0 kg/m2 at Visit 1
- Non- smokers/former users (cessation less than or equal to 12 months)
- Regular bowel movements; not constipated
- Willing to maintain physical activity patterns, body weight, and habitual diet throughout the trial
- Willing to limit alcohol consumption to less than or equal to 2 drinks per day
- Willing to avoid vigorous physical activity for 24 hrs prior to and during visits
- Willing to refrain for exclusionary medications, supplements, and products throughout study.
- Willing to comply with the visit schedule and fecal sample collection/processing/storage requirements
- No health conditions that would prevent him/her from fulfilling the study requirements based on medical history and routine laboratory test results.
- Understands the study procedures and signs forms providing consent and authorization of release of relevant protected health information to investigator
Exclusion
- Abnormal laboratory test results of clinical significance at Visit 1
- Clinically important GI condition that would potentially interfere with the evaluation of the study product
- Recent (within 2 weeks of Visit 1) history of an episode of acute GI illness
- Self reported history (within 6 weeks of visit 1) of constipation
- Uncontrolled and/or clinically important pulmonary, cardiac, hepatic, renal, endocrine, hematologic, immunologic, neurologic, psychiatric or biliary disorders
- Uncontrolled hypertension
- Known allergy, intolerances or sensitivity to any of the ingredients in the study product
- Extreme dietary habits
- History or presence of cancer in the prior 2 years, except for non-melanoma skin cancer
- Major trauma or any other surgical event within 3 months of Visit 1
- Signs or symptoms of an active infection of clinical relevance within 5 days of Visit 1
- Weight loss or gain of greater than 4.5 kg in the 3 months prior to Visit 1
- Currently or planning to be on a weight loss regimen during the duration of the study
- Antibiotic use within 3 months of Visit 1
- Use of steroids within 1 month of Visit 1
- Chronic use of anti-inflammatory medications within 1 month of Visit 1
- Use of medications and or dietary supplements known to influence GI function
- Consumption of fermented foods or beverages that do or might contain live probiotics within 2 weeks of Visit 1
- Participated in endoscopy or endoscopy prep within 3 months of Visit 1
- Female that is pregnant, planning to be pregnant during the study period, lactating, or is unwilling to use a medically approved form of birth control during the study period
- Recent history (within 12 months of screening) of substance abuse
- Has a condition the Investigator believes will interfere with the subjects inability to provide informed consent, confound the interpretation of the results, or put the subject at risk
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2020
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04100460
Start Date
September 1 2019
End Date
May 1 2020
Last Update
September 24 2019
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