Postprandial Blood GlucoseNCT04005924
Effect of an Arabinogalactan Product
A study testing arabinogalactan in people with Postprandial Blood Glucose, run by Biofortis, Merieux NutriSciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postprandial Blood Glucose
- What is being tested?
- arabinogalactan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2019to 8 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Acute, Randomized, Double-blind, Controlled, Crossover Study to Investigate the Effect of an Arabinogalactan Product on Glucose and Insulin Response in Adults
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.
Read the detailed description
The study is an acute, single-center, randomized, controlled, crossover trial with one screening visit (Visit 1; Day -7) and 3 test visits (Visits 2, 3, and 4; Days 0, 7, and 14). The three test visits are each separated by a 7-day washout period.
At Visit 1 (Day -7), subjects will provide informed consent and a fasting capillary blood glucose will be assessed for eligibility purposes (fasting blood glucose must be ≥70 mg/dL and ≤125 mg/dL). At Visit 1, the following will also be conducted: medical history and prior and current medication/supplement use, inclusion and exclusion criteria, and vein access (using the Vein Access Scale; Appendix 2) will be assessed; and height, body weight, and vital signs will be measured; and BMI will be calculated. Fasting (12 ± 2 h) blood samples will be collected for chemistry and hematology, and female subjects <60 years old will undergo an in-clinic urine pregnancy test. Prior to release from the clinic, all subjects will be provided study instructions to follow before the next visit, which include: maintenance of adequate hydration and habitual diet/physical activity (throughout the study); fasting (12 ± 2 h, water only, prior to test visits); consumption of a diet that incorporates at least 150 g of total carbohydrate, refraining from vigorous physical activity (i.e., sweat-inducing exercise), and alcohol consumption (24 h prior to test visits); and refraining from tobacco (1 h before and during test visits). Subjects will then be dispensed a 24-h Diet Record with instructions to record all food and beverage intake the day prior to the first test visit (Visit 2, Day 0) and released from the clinic.
At Visit 2 (Day 0), subjects will arrive at the clinic fasted (12 ± 2 h, water only) to undergo clinic visit procedures (assessment for concomitant medication/supplement use, body weight, and vital signs). Eligible subjects will then be formally entered into the testing phase of the trial and assigned to a random test sequence. Adverse events (AE) will be assessed and subjects will be queried about compliance with study and test day instructions. Additionally, the 24-h Diet Record will be collected and reviewed. Subjects will undergo the glycemic/insulinemic response test with blood glucose concentrations obtained via capillary measurement and insulin concentrations assessed via venous measurement. An intravenous catheter will be inserted at least 10 min prior to the first blood sampling time. In order to maintain patency of the intravenous catheter, the catheter will be flushed with normal saline solution at least hourly. Blood samples will be drawn by venipuncture if the catheter fails.
Baseline capillary and venous blood samples will be collected at t= -15 and -5 min prior to beginning the meal consumption. Subjects will be instructed to begin consumption of the breakfast meal at t = 0 min and required to consume the meal in its entirety within 10 min. Capillary and venous blood samples will then be obtained at t = 15, 30, 45, 60, 75, 90, and 120 ± 5 min, where t=0 is the start of breakfast meal consumption. Additional venous blood samples will be collected as back-ups at all time points. Following the last blood draw, AEs will be assessed and subjects will begin their 7-day washout. Subjects will be dispensed a blank 24-h Diet Record with instructions to record intake the day prior to each test visit (i.e., Visits 3 and 4 (Days 7 and 14) and a copy of their first 24-h Diet Record with instructions to replicate their diet to the best of their abilities the day prior to each test visit (i.e., Visits 3 and 4 (Days 7 and 14). Subjects will also be reminded of the study instructions as per Visit 1, Day -7 (see above).
At Visits 3 and 4 (Day 7 and 14), subjects will return to the clinic, crossover to the next study breakfast meal in their respective test sequence, and repeat the procedures from Visit 2 (Day 0).
- Conditions
- Postprandial Blood Glucose
- Being tested
- arabinogalactan
- Keywords
- blood glucose, blood insulin, postprandial, fiber
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arabinogalactanOther
Also called control breakfast, bread plus jam
Arabinogalactan will be mixed into sugar-free blackberry jam and consumed with the provided bread.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Bread and sugar-free blackberry jam breakfast |
| Low dose | Experimental | Bread and sugar-free blackberry jam breakfast with 6 g arabinogalactan Receives: Other: arabinogalactan |
| High dose | Experimental | Bread and sugar-free blackberry jam breakfast with 21 g arabinogalactan Receives: Other: arabinogalactan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Maximum concentration (Cmax) for postprandial blood glucose during each study visit
Measured: 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
Difference in 2-h incremental area under the curve (iAUC) for postprandial blood insulin between test breakfasts with arabinogalactan and control.
Measured: Blood insulin will be determined at the same 8 time points as blood glucose during 3 study visits.
Cmax of blood insulin
the largest postprandial blood insulin concentration during each study visit
Measured: 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
Time to reach Cmax of blood glucose during each study visit
Measured: 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
Time to reach Cmax of blood insulin during each study visit
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start6 May 2019
- Primary completion19 Aug 2019
- Study completion8 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Postprandial Blood GlucoseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biofortis, Merieux NutriSciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lonza Inc.
- Responsible party
- Sponsor
- Investigators
- Andrea Lawless, MD, Principal investigator, Biofortis, Merieux NutriSciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04005924
- Sponsor's protocol ID
- BIO 1904
- Status last verified
- Jul 2021
- First submitted
- 27 Jun 2019
- Last updated
- 21 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27073407Garcia 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.
PubMed 16988651Garcia 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.
PubMed 17111305Hartvigsen 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.
PubMed 24595224Hartvigsen 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.
PubMed 24253758Lu 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.
PubMed 10799374Robinson 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.
PubMed 11506055Saeed 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.
PubMed 21491271
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Acute, Randomized, Double-blind, Controlled, Crossover Study to Investigate the Effect of an Arabinogalactan Product on Glucose and Insulin Response in Adults
- ClinicalTrials.gov ID
- NCT04005924
- Acronym / sponsor ID
- BIO 1904
- Conditions
- Postprandial Blood Glucose
- Keywords
- blood glucose, blood insulin, postprandial, fiber
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Biofortis, Merieux NutriSciencesIndustry (pharma, biotech, devices)
- Collaborators
- Lonza Inc.
- Study start
- 6 May 2019 (actual)
- Primary completion
- 19 Aug 2019 (actual)
- Study completion
- 8 Oct 2019 (actual)
- First posted
- 2 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study is an acute, single-center, randomized, controlled, crossover trial with one screening visit (Visit 1; Day -7) and 3 test visits (Visits 2, 3, and 4; Days 0, 7, and 14). The three test visits are each separated by a 7-day washout period.
At Visit 1 (Day -7), subjects will provide informed consent and a fasting capillary blood glucose will be assessed for eligibility purposes (fasting blood glucose must be ≥70 mg/dL and ≤125 mg/dL). At Visit 1, the following will also be conducted: medical history and prior and current medication/supplement use, inclusion and exclusion criteria, and vein access (using the Vein Access Scale; Appendix 2) will be assessed; and height, body weight, and vital signs will be measured; and BMI will be calculated. Fasting (12 ± 2 h) blood samples will be collected for chemistry and hematology, and female subjects <60 years old will undergo an in-clinic urine pregnancy test. Prior to release from the clinic, all subjects will be provided study instructions to follow before the next visit, which include: maintenance of adequate hydration and habitual diet/physical activity (throughout the study); fasting (12 ± 2 h, water only, prior to test visits); consumption of a diet that incorporates at least 150 g of total carbohydrate, refraining from vigorous physical activity (i.e., sweat-inducing exercise), and alcohol consumption (24 h prior to test visits); and refraining from tobacco (1 h before and during test visits). Subjects will then be dispensed a 24-h Diet Record with instructions to record all food and beverage intake the day prior to the first test visit (Visit 2, Day 0) and released from the clinic.
At Visit 2 (Day 0), subjects will arrive at the clinic fasted (12 ± 2 h, water only) to undergo clinic visit procedures (assessment for concomitant medication/supplement use, body weight, and vital signs). Eligible subjects will then be formally entered into the testing phase of the trial and assigned to a random test sequence. Adverse events (AE) will be assessed and subjects will be queried about compliance with study and test day instructions. Additionally, the 24-h Diet Record will be collected and reviewed. Subjects will undergo the glycemic/insulinemic response test with blood glucose concentrations obtained via capillary measurement and insulin concentrations assessed via venous measurement. An intravenous catheter will be inserted at least 10 min prior to the first blood sampling time. In order to maintain patency of the intravenous catheter, the catheter will be flushed with normal saline solution at least hourly. Blood samples will be drawn by venipuncture if the catheter fails.
Baseline capillary and venous blood samples will be collected at t= -15 and -5 min prior to beginning the meal consumption. Subjects will be instructed to begin consumption of the breakfast meal at t = 0 min and required to consume the meal in its entirety within 10 min. Capillary and venous blood samples will then be obtained at t = 15, 30, 45, 60, 75, 90, and 120 ± 5 min, where t=0 is the start of breakfast meal consumption. Additional venous blood samples will be collected as back-ups at all time points. Following the last blood draw, AEs will be assessed and subjects will begin their 7-day washout. Subjects will be dispensed a blank 24-h Diet Record with instructions to record intake the day prior to each test visit (i.e., Visits 3 and 4 (Days 7 and 14) and a copy of their first 24-h Diet Record with instructions to replicate their diet to the best of their abilities the day prior to each test visit (i.e., Visits 3 and 4 (Days 7 and 14). Subjects will also be reminded of the study instructions as per Visit 1, Day -7 (see above).
At Visits 3 and 4 (Day 7 and 14), subjects will return to the clinic, crossover to the next study breakfast meal in their respective test sequence, and repeat the procedures from Visit 2 (Day 0).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Bread and sugar-free blackberry jam breakfast |
| Low dose | Experimental | Other: arabinogalactanBread and sugar-free blackberry jam breakfast with 6 g arabinogalactan |
| High dose | Experimental | Other: arabinogalactanBread and sugar-free blackberry jam breakfast with 21 g arabinogalactan |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| arabinogalactanAlso: control breakfast, bread plus jamArabinogalactan will be mixed into sugar-free blackberry jam and consumed with the provided bread. | Other | High dose, Low dose |
Primary outcome
iAUC of blood glucose
Time frame: 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.
Difference in 2-h incremental area under the curve (iAUC) for postprandial blood glucose between test breakfasts with arabinogalactan and control.
5 secondary outcomes
Cmax of blood glucose
Time frame: 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
Time frame: Blood insulin will be determined at the same 8 time points as blood glucose during 3 study visits.
Cmax of blood insulin
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
- Background: PubMed 27073407Dion 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.
- Background: PubMed 16988651Garcia 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.
- Background: PubMed 17111305Garcia 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.
- Background: PubMed 24595224Hartvigsen 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.
- Background: PubMed 24253758Hartvigsen 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.
- Background: PubMed 10799374Lu 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.
- Background: PubMed 11506055Robinson 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.
- Background: PubMed 21491271Saeed 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.
- 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.Link provided by the sponsor.
- What We Eat in America, NHANES 2015-2016.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Lawless, MD principal investigator
Biofortis, Merieux NutriSciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing arabinogalactan in people with Postprandial Blood Glucose, run by Biofortis, Merieux NutriSciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
iAUC of blood glucose (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04005924, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2021.