Effect of an Arabinogalactan Product

NCT04005924 | Completed

• 1 other identifier: BIO 1904
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postprandial Blood Glucose

Keywords

blood glucose; blood insulin; postprandial; fiber

Outcome Measures

Primary Outcomes (1)

• iAUC of blood glucose

  Difference in 2-h incremental area under the curve (iAUC) for postprandial blood glucose between test breakfasts with arabinogalactan and control.

  Blood glucose will be determined at 8 time points, including immediately prior to the consumption of breakfast and up to 2 hours post consumption, during 3 study visits.

Secondary Outcomes (5)

• Cmax of blood glucose

  Cmax will be obtained during 3 study visits. Blood glucose will be determined at 8 time points including immediately prior to the consumption of breakfast and up to 2 hours post consumption.

• iAUC of blood insulin

  Blood insulin will be determined at the same 8 time points as blood glucose during 3 study visits.

• Cmax of blood insulin

  Cmax will be obtained during 3 study visits. Blood insulin will be determined at 8 time points including immediately prior to the consumption of breakfast and up to 2 hours post consumption.

• Tmax of blood glucose

  Tmax will be obtained during 3 study visits. Blood glucose will be determined at 8 time points including immediately prior to the consumption of breakfast and up to 2 hours post consumption.

• Tmax of blood insulin

  Tmax will be obtained during 3 study visits. Blood insulin will be determined at 8 time points including immediately prior to the consumption of breakfast and up to 2 hours post consumption.

Study Arms (3)

Control

NO INTERVENTION

Bread and sugar-free blackberry jam breakfast

Low dose

EXPERIMENTAL

Bread and sugar-free blackberry jam breakfast with 6 g arabinogalactan

Other: arabinogalactan

High dose

EXPERIMENTAL

Bread and sugar-free blackberry jam breakfast with 21 g arabinogalactan

Other: arabinogalactan

Interventions

arabinogalactan OTHER

Arabinogalactan will be mixed into sugar-free blackberry jam and consumed with the provided bread.

Also known as: control breakfast, bread plus jam

High dose; Low dose

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

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

Study Sites (1)

Oliver Chen

Addison, Illinois, 60101, United States

Location

Related Publications (8)

• Dion C, Chappuis E, Ripoll C. Does larch arabinogalactan enhance immune function? A review of mechanistic and clinical trials. Nutr Metab (Lond). 2016 Apr 12;13:28. doi: 10.1186/s12986-016-0086-x. eCollection 2016.

  PMID: 27073407 BACKGROUND

• Garcia AL, Otto B, Reich SC, Weickert MO, Steiniger J, Machowetz A, Rudovich NN, Mohlig M, Katz N, Speth M, Meuser F, Doerfer J, Zunft HJ, Pfeiffer AH, Koebnick C. Arabinoxylan consumption decreases postprandial serum glucose, serum insulin and plasma total ghrelin response in subjects with impaired glucose tolerance. Eur J Clin Nutr. 2007 Mar;61(3):334-41. doi: 10.1038/sj.ejcn.1602525. Epub 2006 Sep 20.

  PMID: 16988651 BACKGROUND

• Garcia AL, Steiniger J, Reich SC, Weickert MO, Harsch I, Machowetz A, Mohlig M, Spranger J, Rudovich NN, Meuser F, Doerfer J, Katz N, Speth M, Zunft HJ, Pfeiffer AH, Koebnick C. Arabinoxylan fibre consumption improved glucose metabolism, but did not affect serum adipokines in subjects with impaired glucose tolerance. Horm Metab Res. 2006 Nov;38(11):761-6. doi: 10.1055/s-2006-955089.

  PMID: 17111305 BACKGROUND

• Hartvigsen ML, Laerke HN, Overgaard A, Holst JJ, Bach Knudsen KE, Hermansen K. Postprandial effects of test meals including concentrated arabinoxylan and whole grain rye in subjects with the metabolic syndrome: a randomised study. Eur J Clin Nutr. 2014 May;68(5):567-74. doi: 10.1038/ejcn.2014.25. Epub 2014 Mar 5.

  PMID: 24595224 BACKGROUND

• Hartvigsen ML, Gregersen S, Laerke HN, Holst JJ, Bach Knudsen KE, Hermansen K. Effects of concentrated arabinoxylan and beta-glucan compared with refined wheat and whole grain rye on glucose and appetite in subjects with the metabolic syndrome: a randomized study. Eur J Clin Nutr. 2014 Jan;68(1):84-90. doi: 10.1038/ejcn.2013.236. Epub 2013 Nov 20.

  PMID: 24253758 BACKGROUND

• Lu ZX, Walker KZ, Muir JG, Mascara T, O'Dea K. Arabinoxylan fiber, a byproduct of wheat flour processing, reduces the postprandial glucose response in normoglycemic subjects. Am J Clin Nutr. 2000 May;71(5):1123-8. doi: 10.1093/ajcn/71.5.1123.

  PMID: 10799374 BACKGROUND

• Robinson RR, Feirtag J, Slavin JL. Effects of dietary arabinogalactan on gastrointestinal and blood parameters in healthy human subjects. J Am Coll Nutr. 2001 Aug;20(4):279-85. doi: 10.1080/07315724.2001.10719048.

  PMID: 11506055 BACKGROUND

• Saeed F, Pasha I, Anjum FM, Sultan MT. Arabinoxylans and arabinogalactans: a comprehensive treatise. Crit Rev Food Sci Nutr. 2011 May;51(5):467-76. doi: 10.1080/10408391003681418.

  PMID: 21491271 BACKGROUND

Related Links

• Scientific evaluation of the evidence on the beneficial physiological effects of isolated or synthetic non-digestible carbohydrates submitted as a Citizen Petition (21 CFR 10.30): Guidance for Industry.
• What We Eat in America, NHANES 2015-2016.

MeSH Terms

Interventions

arabinogalactan; Bread; Junctional Adhesion Molecule A

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Junctional Adhesion Molecules; Cell Adhesion Molecules; Membrane Glycoproteins; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins; Membrane Proteins; Receptors, Cell Surface; Tight Junction Proteins; Antigens, Surface; Antigens; Biological Factors

Study Officials

• Andrea Lawless, MD

  Biofortis, Merieux NutriSciences

  PRINCIPAL INVESTIGATOR

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: June 27, 2019
• First Posted: July 2, 2019
• Study Start: May 6, 2019
• Primary Completion: August 19, 2019
• Study Completion: October 8, 2019
• Last Updated: July 21, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)