Status:
COMPLETED
To Investigate the Effect of Arabinogalactan on the Gut Microbiome in Adults
Lead Sponsor:
Biofortis, Merieux NutriSciences
Collaborating Sponsors:
Lonza Inc.
Conditions:
Gut Microbiota
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
Dietary fiber is an important nutrient that supports gastrointestinal function, as well as the maintenance of blood glucose and cholesterol. Additionally, it is suggested that dietary fiber may provid...
Detailed Description
The study is a randomized, crossover, single-center trial with one screening visit (Visit 1; Week -1) and 2 test periods \[Test Period I (Visits 2, 3, and 4; Weeks 0, 3, and 6) and Test Period II (Vis...
Eligibility Criteria
Inclusion
- BMI of 18.0 to 32.0 kg/m2, inclusive, at Visit 1 (Week -1).
- Self-reported regular bowel movement at Visit 1 (Week -1).
- Non-user of all tobacco and smoking products (including, but not limited to cigarettes, cigars, chewing tobacco, e-cigarettes) and nicotine products (e.g., nicotine patches, nicotine gums) and has no plans to change smoking habits during the study period.
- Non-user of any marijuana or hemp products and has no plans to use marijuana or hemp products during the study period.
- Willing to maintain physical activity patterns, body weight, and habitual diet throughout the trial, except for exclusion of fermented foods that do or might contain live probiotics (e.g., yogurt, kombucha) and inclusion of study products.
- Willing to abstain from alcohol consumption and avoid vigorous physical activity for 24 h prior to and during Visits 1, 2, 4, 5, and 7 (Weeks -1, 0, 6, 9, and 15).
- Willing to refrain from exclusionary medications, supplements, and products throughout the study.
- Willing and able to comply with the visit schedule and fecal sample collection/processing/storage requirements during the study period.
- No health conditions that would prevent him/her from fulfilling the study requirements as judged by the Clinical Investigator on the basis of medical history and routine laboratory test results.
- Understands the study procedures and signs forms providing informed consent to participate in the study and authorizes the release of relevant protected health information to the Clinical Investigator.
Exclusion
- Abnormal laboratory test results of clinical significance at Visit 1 (Week -1), at the discretion of the Clinical Investigator. One re-test will be allowed on a separate day prior to Visit 2 (Week 0), for subjects with abnormal laboratory test results.
- Clinically important GI condition that would potentially interfere with the evaluation of the study product (e.g., inflammatory bowel disease, irritable bowel syndrome, gastric reflux, indigestion, dyspepsia, Crohn's disease, celiac disease, history of surgery for weight loss, gastroparesis, and clinically significant lactose and gluten intolerance or allergies).
- Recent (within 2 weeks of Visit 1; Week -1) history of an episode of acute GI illness such as nausea/vomiting or diarrhea (defined as ≥3 loose or liquid stools/day).
- Self-reported history (within 6 weeks of Visit 1; Week -1) of constipation (defined as \<3 bowel movements per week).
- History or presence of uncontrolled and/or clinically important pulmonary (including uncontrolled asthma), cardiac (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), hepatic, renal, endocrine, hematologic, immunologic, neurologic (such as Alzheimer's or Parkinson's disease), psychiatric (including depression and/or anxiety disorders) or biliary disorders.
- Uncontrolled hypertension (systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg) as defined by the blood pressure measured at Visit 1 (Week -1).
- One re-test will be allowed on a separate day prior to Visit 2 (Week 0), for subjects whose blood pressure exceeds either of these cut points at Visit 1 (Week -1), in the judgment of the Clinical Investigator.
- Known allergy intolerances or sensitivity to any of the ingredients in the study product (Appendix 8).
- Extreme dietary habits (e.g., Atkins diet/ketogenic diet, very high protein, very high fiber, vegetarian), in the opinion of the Clinical Investigator.
- 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 (Week -1).
- Signs or symptoms of an active infection of clinical relevance within 5 days of Visit 1 (Week -1). The visit may be rescheduled such that all signs and symptoms have resolved (at the discretion of the Clinical Investigator) at least 5 days prior to Visit 1 (Week -1). If an infection occurs during the study period, test visits will be rescheduled until all signs and symptoms have resolved (at the discretion of the Clinical Investigator) at least 5 days prior to study visits.
- Weight loss or gain \>4.5 kg in the 3 months prior to Visit 1 (Week -1).
- Currently or planning to be on a weight loss regimen during the duration of the study.
- Antibiotic use within 2 months of Visit 1 (Week -1).
- Use of steroids within 1 month of Visit 1 (Week -1).
- Chronic use (i.e., daily on a regular basis) of anti-inflammatory medications (e.g., NSAIDs) within 1 month of Visit 1 (Week -1).
- Use of medications (over-the-counter or prescription) and/or dietary supplements, known to influence GI function, including but not limited to prebiotics or probiotics, laxatives, enemas, fiber supplements and/or suppositories, anti-diarrheal agents, and/or anti-spasmodic within 2 weeks of Visit 1 (Week -1).
- Bismuth subsalicylate (e.g., Pepto Bismol) and antacids (e.g., Tums) ≤2 times/ week starting from 2 weeks prior to Visit 1 (Week -1), with the exception of 7 days prior to the stool collection period, during which consumption of these products are not allowed.
- Consumption of fermented foods or beverages that do or might contain live probiotics (Appendix 1) within 2 weeks of Visit 1 (Week -1).
- Participated in colonoscopy or colonoscopy preparation within 3 months prior to Visit 1 (day -14).
- Exposure to any non-registered drug product within 4 weeks prior to Visit 1 (Week - 1).
- Recent history of (within 12 months of screening; Visit 1; Week -1) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as \>14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1½ oz distilled spirits).
- Has a condition the Clinical Investigator believes would interfere with his ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results, or put the subject at undue risk.
Key Trial Info
Start Date :
August 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 18 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04351841
Start Date
August 5 2019
End Date
December 18 2019
Last Update
April 22 2020
Active Locations (1)
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1
Oliver Chen
Addison, Illinois, United States, 60101