To Investigate the Effect of Arabinogalactan on the Gut Microbiome in Adults

NCT04351841 | Completed

• 1 other identifier: BIO 1906
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 provide other health benefits, such as maintenance of healthy weight through effects on satiety. Furthermore, dietary fiber can improve health by modulating the microbial communities residing in human gut, particularly in the large intestine. The microbes in the gut modulate a wide variety of biological processes essential for health of the host. Currently, the average intake of fiber in the U.S. is \~40-50% below adequate intake levels. ResitAid, a Lonza's arabinogalactan, is a hemicellulose that is abundant in plants. Arabinogalactans including ResitAid are found in seeds, leaves, roots, and fruit of higher plants, such as cereals, beans, leeks, pear, corn, bark, and wheat. ResitAid, the arabinogalactan ingredient used in this study, is isolated from larch (Larix laricina) using a patented water-based extraction process. ResitAid has been designated as Generally Recognized as Safe (GRAS) by the U.S. FDA for multiple uses and has been used in numerous previous clinical studies in humans, with no significant safety issues observed at intakes of up to 30 g daily for up to 6 weeks. It was reported that 15 g and 30 g of different preparation of arabinogalactan could significantly increase certain microbial populations considered to be beneficial (e.g., Lactobacillus spp.). Nevertheless, more clinical evidence is needed to support the effect of ResistAid on the microbial composition in the gut. This study is designed to investigate the effect of daily consumption of 15 g of ResitAid on the gastrointestinal microbial profile and fecal short-chain fatty acid contents in healthy adults. Primary Objective: Modulation of the microbiome Secondary objectives:

1. 1.Changes in Lactobacillus ssp.
2. 2.Changes in Bifidobacterium ssp.
3. 3.Changes in SCFA
4. 4.Changes in bowel movement
5. 5.Changes in the SF-36 questionnaire

Conditions

Gut Microbiota

Keywords

microbiome; stool; indigestible carbohydrate

Outcome Measures

Primary Outcomes (2)

• composition of fecal microbiome

  relative abundance of bacteria and alpha- and beta-diversity

  up to 6 weeks

• Concentration of fecal short-chain fatty acids

  acetate, butyrate, propionate, valerate, isobutyrate, and isovalerate contents (ug/g wet stool)

  Change from the baseline at 6 weeks

Secondary Outcomes (7)

• Bowel Movement

  Change from the baseline at 6 weeks

• stool consistency

  Change from the baseline at 6 weeks

• sensation of incomplete evacuation during bowel movement

  Change from the baseline at 6 weeks

• straining during bowel movement

  Change from the baseline at 6 weeks

• discomfort during bowel movement

  Change from the baseline at 6 weeks

Study Arms (2)

control

PLACEBO COMPARATOR

15 g maltodextrin per day consumed in the morning

Other: maltodextrin

Active

EXPERIMENTAL

15 g arabinogalactan per day consumed in the morning

Other: arabinogalactan

Interventions

arabinogalactan OTHER

A beverage will be prepared by thoroughly mixing the 15 g of arabinogalactan with water and Crystal Light flavoring

Active

maltodextrin OTHER

A beverage will be prepared by thoroughly mixing the 15 g of maltodextrin with water and Crystal Light flavoring

control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 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 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Biofortis, Merieux NutriSciences: lead
• Lonza Inc.: collaborator

Study Sites (1)

Oliver Chen

Addison, Illinois, 60101, United States

Location

MeSH Terms

Interventions

arabinogalactan; maltodextrin

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2020
• First Posted: April 17, 2020
• Study Start: August 5, 2019
• Primary Completion: December 18, 2019
• Study Completion: December 18, 2019
• Last Updated: April 22, 2020

Record last verified: 2020-04

Locations

US (1)