To Investigate the Effect of Arabinogalactan on the Gut Microbiome in Adults
Condition: Gut Microbiota
Study type: Interventional

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
    

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 (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.
    

Intervention name(s): arabinogalactan; maltodextrin
Intervention type(s): Other; Other
Intervention description(s): A beverage will be prepared by thoroughly mixing the 15 g of arabinogalactan with water and Crystal Light flavoring; A beverage will be prepared by thoroughly mixing the 15 g of maltodextrin with water and Crystal Light flavoring
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: microbiome; stool; indigestible carbohydrate