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

Gut Microbiota Clinical Trial

Official title: A Randomized, Double-blind, Placebo-controlled, Crossover Study to Investigate the Effect of an Arabinogalactan Product for 6 Weeks on the Gut Microbiome in Adults

Status Completed

Clinical Trial 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. Changes in Lactobacillus ssp.

2. Changes in Bifidobacterium ssp.

3. Changes in SCFA

4. Changes in bowel movement

5. Changes in the SF-36 questionnaire

Clinical Trial 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 (Visits 5, 6, and 7; Weeks 9, 12 and 15)] separated by a minimum 3-week washout period.

At Visit 1 (Week -1), subjects will provide informed consent and undergo assessments of medical history and medication/supplement use, and inclusion and exclusion criteria. Fasting (12 ± 2 h) blood samples will be collected for chemistry and hematology. Subjects will be counseled to exclude fermented foods or beverages that do or might contain live probiotics (e.g., yogurt, kombucha). Subjects will also be dispensed a gastrointestinal (GI) and Bowel Habits Diary and stool collection kit. Subjects will be instructed to complete the GI and Bowel Habits Diary during the 3 days prior to Visit 2 (Week 0) and to collect fecal samples from one bowel movement during the 3 days prior to Visit 2 (Week 0).

At Visit 2 (Week 0), subjects will arrive at the clinic fasted (12 ± 2 h, water only) to undergo clinic visit procedures. Adverse events (AE) will be assessed and the SF-36 Questionnaire will be administered. Fecal samples will be collected and the GI and Bowel Habits Diary will be collected and reviewed. Subjects will be randomly assigned to a study product for home consumption with or without breakfast in the morning. Subjects will be dispensed a GI and Bowel Habits Diary and stool collection kit and will be instructed to complete the diary during the 3 days immediately prior to Visit 3 (Week 3) and to collect fecal samples from one bowel movement during the same 3 days immediately prior to Visit 3 (Week 3).

At Visit 3 (Week 3), subjects will return to the clinic for clinic visit procedures. AEs will be assessed and the SF-36 Questionnaire will be administered. The fecal samples will be collected and the GI and Bowel Habits Diary will be collected and reviewed. Study product will be re-dispensed back to subjects for home consumption. Subjects will be dispensed a GI and Bowel Habits Diary and stool collection kit and will be instructed to complete the diary during the 3 days immediately prior to Visit 4 (Week 6) and to collect fecal samples during the same period.

At Visit 4 (Week 6), subjects will arrive at the clinic fasted (12 ± 2 h, water only) to undergo clinic visit procedures. AEs will be assessed and the SF-36 Questionnaire will be administered. Subjects will be queried about compliance with study instructions. The fecal samples will be collected and GI and Bowel Habits Diary will be collected and reviewed. Fasting (12 ± 2 h) blood samples will be collected for chemistry and hematology. Subjects will be dispensed a stool collection kit and will be instructed to collect fecal samples from one bowel movement during the 3 days immediately prior to Visit 5 (Week 9). Subjects will be instructed to begin the 3-week washout period and return to the clinic to begin Test Period II at Visit 5 (Week 9).

At Visit 5 (Week 9), subjects will return to the clinic fasted (12 ± 2 h, water only), crossover to the other study product in their test sequence, and repeat the procedures from Visits 2 (Week 0) with the exclusion of the randomization procedure. At Visit 6 (Week 12), subjects will repeat the procedures from Visit 3 (Week 3) and at Visit 7 (Week 15), subjects will repeat the procedures from Visit 4 (Week 6). Subjects will be dismissed at the end of Visit 7. ;

Related Conditions & MeSH terms

• Gut Microbiota

• NCT number: NCT04351841
• Study type: Interventional
• Source: Biofortis, Merieux NutriSciences
• Status: Completed
• Phase: N/A
• Start date: August 5, 2019
• Completion date: December 18, 2019