Effect of an Arabinogalactan Product

Completed · Not applicable

Conditions studied: Postprandial Blood Glucose

In brief

Dietary fiber is an important nutrient that supports gastrointestinal function as well as blood glucose and cholesterol maintenance. The National Academy of Sciences Institute of Medicine (IOM) established an adequate intake for fiber as 14 g/kcal, or 38 g and 25 g for men and women, respectively. Currently, however, the majority of the U.S. population falls substantially below this level, with mean intakes of 18.9 g/day and 15.7 g/day in men and women age 20 and older, respectively. Fiber is a complex category that contains a number of different polysaccharides and oligosaccharides that are not digested in the upper gastrointestinal tract. In its final rule updating the Nutrition and Supplement Facts label regulations, which was published in May 2016, the U.S. FDA revised the definition of dietary fiber for food labeling and included two categories: (1) the intrinsic and intact non-digestible carbohydrate (NDC) and lignin, and (2) the isolated or synthesized NDC. In this re-definition, those NDCs that are isolated from plant and other food sources will now require clinical data indicating that the ingredient provides a physiological effect that is beneficial to human health. This study is designed to test the effect of an isolated NDC, arabinogalactan, on attenuation of blood glucose and/or insulin. Attenuation of blood glucose and/or insulin is one of the outcomes identified by the U.S. FDA as a physiological effect that is beneficial to human health, and as such, can be used to support that an isolated NDC is acting as a fiber (FDA 2018). Arabinogalactans are hemicelluloses that are abundant in plants. Arabinogalactans are found in seeds, leaves, roots, and fruit of higher plants, such as cereals, beans, leeks, pear, corn, and wheat (Saeed 2011; Dion 2016). The arabinogalactan ingredient used in the study is isolated from larch (Larix laricina) using a patented water-based extraction process. Larch arabinogalactan has been designated as Generally Recognized as Safe (GRAS) by the U.S. FDA (2000) 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. The present study was designed with the goal to assess the effect of acute consumption of arabinogalactan on blood glucose and insulin responses.

Key facts

Study ID

NCT04005924

Run by

Biofortis, Merieux NutriSciences

People needed

20

Starts

2019-05-06

Expected to finish

2019-10-08

Last updated by the study team

2021-07-21

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subject is a male or female, 21-65 years of age, inclusive at Visit 1 (Day -7).
• Subject has a BMI of 18.5 to 32.0 kg/m2, inclusive, at Visit 1 (Day -7).
• Subject has a rating of 7 to 10 on the Vein Access Scale at Visit 1 (Day -7; Appendix 2).
• Subject has no plans to change smoking habits during the study period and is able to abstain from tobacco products 1 h prior to and during each test visit (Visits 2, 3, and 4; Days 0, 7 and 14).
• Subject is willing to maintain physical activity patterns, body weight, and habitual diet throughout the trial.
• Subject is willing to abstain from alcohol consumption and avoid vigorous physical activity for 24 h prior to all test visits (Visits 2, 3, and 4; Days 0, 7, and 14).
• Subject has 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.
• Subject 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…

• Subject has diagnosed diabetes mellitus (Type 1 or Type 2) or fasting glucose >125 mg/dL at Visit 1 (Day -7).
• Subject has a fasting glucose <70 mg/dL at Visit 1 (Day -7).
• Subject has a 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, gastrointestinal (including but not limited to inflammatory bowel diseases, such as Crohn's disease and ulcerative colitis, celiac disease), endocrine, hematologic, immunologic, neurologic (such as Alzheimer's or Parkinson's disease), psychiatric (including depression and/or anxiety disorders) or biliary disorders.
• Subject has a known allergy (e.g. gluten allergy), intolerance (e.g. gluten intolerance), or sensitivity to any of the foods or ingredients in the study meals.
• Subject has extreme dietary habits (e.g., Atkins diet/ketogenic, very high protein, very high fiber, vegetarian), in the opinion of the Clinical Investigator.
• Subject has 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 (Day -7). One re-test will be allowed on a separate day prior to Visit 2 (Day 0), for subjects whose blood pressure exceeds either of these cut points at Visit 1 (Day -7), in the judgment of the Clinical Investigator.
• Subject has a history or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.
• Subject has a history of bariatric surgery for weight reducing purposes.
• Subject has experienced any major trauma or any other surgical event within 3 months of Visit 1 (Day -7).
• Subject has had a weight loss or gain >4.5 kg in the 3 months prior to Visit 1 (Day -7).
• Subject has used any over-the-counter or prescription medications [with the exception of contraceptives, stable dose (defined as 90 days prior to Visit 1) statins and anti-hypertensive medications] and/or dietary supplements (other than a standard multivitamin/mineral supplement) within 3 weeks of Visit 1 (Day -7).
• Subject has any signs or symptoms of an active infection of clinical relevance (e.g., urinary tract or respiratory) within 5 days prior to Visit 1.
• Subject has been exposed to any non-registered drug product within 30 days prior to Visit 1 (Day -7).
• Subject is a heavy smoker (defined as 1 pack/day of cigarettes) and/or user of marijuana products or products that contain cannabinoids.
• Subject has a recent history of (within 12 months of screening; Visit 1; Day -7) 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).
• Subject 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.

Where it is running

• Oliver Chen — Addison, Illinois, United States

Full record on ClinicalTrials.gov

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