HealthyNCT02367989
Effects of Barley on Glucose Control
A study testing 0g barley β-glucan no fibre, 2g barley β-glucan and 4g barley β-glucan in people with Healthy, run by St. Boniface Hospital at 1 site in Canada.
Trial summary
Lifestyle modifications that include a diet high in fibre may lower the risk of developing type 2 diabetes (CDA, 2013). In this context, the presence of soluble dietary fibre in carbohydrate rich foods has been widely recognized for its effect on post-prandial glucose response (PPGR). Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 0g barley β-glucan no fibre, 2g barley β-glucan and 4g barley β-glucan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 8 Nov 2017to Jan 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Generally healthy male or female, between the age of 18-40 years;
- Body mass index (BMI) 18.5-30.0 kg/m2;
- Habitually consume breakfast, lunch and dinner in the morning, mid-day and evening, respectively;
- Willing to provide informed consent;
- Willing/able to comply with the requirements of the study.
Who cannot join
- Pregnant or lactating;
- Medical history of diabetes mellitus, fasting plasma glucose ≥7.0 mmol/L, HbA1c ≥6.0%, or use of insulin or oral medication to control blood sugar;
- Medical history of cardiovascular disease;
- Systolic blood pressure >140 mm Hg or diastolic blood pressure >90 mm Hg;
- Fasting plasma total cholesterol >7.8 mmol/L;
- Fasting plasma HDL <0.9 mmol/L;
Show all 22Show fewer
- Fasting plasma LDL >5.0 mmol/L;
- Fasting plasma triglycerides >2.3 mmol/L;
- Major surgery within the last 3 months;
- Medical history of inflammatory disease (ie. Systemic lupus erythematosis, rheumatoid arthritis, psoriasis) or use of any corticosteroid medications within 3 months;
- Medical history of liver disease or liver dysfunction (defined as plasma AST or ALT ≥1.5 times the upper limit of normal (ULN));
- Medical history of kidney disease or kidney dysfunction (defined as blood urea nitrogen and creatinine ≥ 1.8 times the ULN));
- Presence of a gastrointestinal disorder, daily use of any stomach acid-lowering medications or laxatives (including fibre supplements) within the past month or antibiotic use with the past 6 weeks;
- Active treatment for any type of cancer within 1 year prior to study start;
- Other medical, psychiatric, or behavioral factors that in the judgment of the principal Investigator may interfere with study participation or the ability to follow the intervention protocol;
- Shift worker (a system of employment where an individual's normal hours of work are in part, outside the period of normal working day; 6am and 8pm);
- Smoking, use of tobacco or a nicotine replacement product (within the last 3 months);
- Allergies to barley or wheat flour;
- Aversion or unwillingness to eat study foods;
- Use of any prescription or non-prescription drug, herbal or nutritional supplement known to affect glycemia;
- Participation in another clinical trial, current or in the past 4 weeks;
- Unstable body weight (defined as >5% change in 3 months) or actively participating in a weight loss program.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Dose-response, Double-blind, Randomized, Controlled, Cross-over Trial Examining the Effect of Barley Beta-glucan on Post-prandial Glucose Response in Healthy Adults
Lifestyle modifications that include a diet high in fibre may lower the risk of developing type 2 diabetes (CDA, 2013). In this context, the presence of soluble dietary fibre in carbohydrate rich foods has been widely recognized for its effect on post-prandial glucose response (PPGR). Among these, oat and barley derived β-glucan have received tremendous attention for their biological effects, including their ability to reduce PPGR in a wide variety of food matrices (Poppitt et al, 2007). A health claim for PPGR would increase market demand for food grade barley, and help those who want to limit the rise in blood sugar after a meal choose products to meet their goals, but there are several gaps in the literature that need to be filled before a submission to Health Canada can be successful: 1) test foods in appropriate serving sizes; 2) test both the glucose and insulin response; 3) include a reference product that matches in total fibre, macronutrient, and energy profile; 4) perform dose response. The proposed study design will address all of these gaps in the current literature and take into consideration Health Canada's guidance document for health claims related to the reduction in PPGR, which sets out the criteria by which the validity of such claims will be assessed.
Hypothesis:
Read more
Barley β-glucan will reduce the PPGR in healthy participants in a dose dependent manner.
Specific objectives:
- To determine the minimum and most effective dose of barley β-glucan in waffles on PPGR and insulin response in a cross-over, randomized, controlled clinical trial.
- To assess the effect of barley β-glucan in waffles on appetite-related sensations using visual analog scales.
- To demonstrate whether the test and reference products were liked or disliked similarly by participants.
- To assess any gastrointestinal side effects from eating the test products
Read the detailed description
A double-blind, randomized, controlled, cross-over study designed to examine the PPGR to barley β-glucan will be conducted at the I.H. Asper Clinical Research Institute in Winnipeg, Manitoba. A total of 24 healthy volunteers will participate in the trial. Eligible participants who have provided consent will be asked to attend 5 clinic visits in a fasted state. At each visit hey will be given 1 set of waffles to eat that contains either 0g, 2g, 4g, or 6g of barley β-glucan, 7 finger pokes to collect capillary blood, 5 questionnaires about their appetite and a questionnaire about the acceptability of the quick bread. Each visit will last approximately 2.5h and be separated by 3-14 days.
- Conditions
- Healthy
- Being tested
- 0g barley β-glucan no fibre, 2g barley β-glucan, 4g barley β-glucan, 6g barley β-glucan, 0g barley β-glucan with fibre
- Keywords
- Glucose response, Insulin response, Satiety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0g barley β-glucan no fibreDietary supplement
Food containing no barley β-glucan and no additional fibre
2g barley β-glucanDietary supplement
Food containing low amounts of barley β-glucan
4g barley β-glucanDietary supplement
Food containing medium amounts of barley β-glucan
6g barley β-glucanDietary supplement
Food containing high amounts of barley β-glucan
0g barley β-glucan with fibreDietary supplement
Food containing no barley β-glucan, but matches fibre content in β-glucan treatments
| Study group | Role | What they receive |
|---|---|---|
| Control without fibre | Placebo comparator | Intervention: 0g barley β-glucan no fibre.
Dose provided in waffles given as breakfast to fasting participant at 1 of 5 visits. Receives: Dietary Supplement: 0g barley β-glucan no fibre |
| low barley β-glucan | Experimental | Intervention: 2g barley β-glucan
Dose provided in waffles given as breakfast to fasting participant at 1 of 5 visits. Receives: Dietary Supplement: 2g barley β-glucan |
| medium barley β-glucan | Experimental | Intervention: 4g barley β-glucan
Dose provided in waffles given as breakfast to fasting participant at 1 of 5 visits. Receives: Dietary Supplement: 4g barley β-glucan |
| high barley β-glucan | Experimental | Intervention: 6g barley β-glucan
Dose provided in waffles given as breakfast to fasting participant at 1 of 5 visits. Receives: Dietary Supplement: 6g barley β-glucan |
| control with fibre | Placebo comparator | Intervention: 0g barley β-glucan with fibre
Dose provided in waffles given as breakfast to fasting participant at 1 of 5 visits. Receives: Dietary Supplement: 0g barley β-glucan with fibre |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-prandial glucose response
Incremental area under the curve for glucose (mmol*min/L)
Measured: 120 minutes
Post-prandial insulin response
Incremental area under the curve for insulin (uIU*min/mL)
Measured: 120 min
Secondary outcomes (4)
hunger
total area under the curve (AUC) using visual analog scales
Measured: 120 min
fullness
total area under the curve (AUC) using visual analog scales
Measured: 120 min
desire to eat
total area under the curve (AUC) using visual analog scales
Measured: 120 min
prospective consumption
total area under the curve (AUC) using visual analog scales
Measured: 120 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2015 (estimated)
- Study start8 Nov 2017
- Primary completion29 Aug 2018
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Boniface Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Agriculture and Agri-Food Canada
- Responsible party
- Principal investigator, Dr. Heather Blewett, St. Boniface Hospital
- Investigators
- Heather Blewett, PhD, Principal investigator, Agriculture and Agri-Food Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02367989
- Sponsor's protocol ID
- 1333
- Status last verified
- Nov 2024
- First submitted
- 4 Feb 2015
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ames NP, Rhymer CR. Issues surrounding health claims for barley. J Nutr. 2008 Jun;138(6):1237S-43S. doi: 10.1093/jn/138.6.1237S.
PubMed 18492863Aziz A, Dumais L, Barber J. Health Canada's evaluation of the use of glycemic index claims on food labels. Am J Clin Nutr. 2013 Aug;98(2):269-74. doi: 10.3945/ajcn.113.061770. Epub 2013 Jun 12.
PubMed 23761481Biorklund M, van Rees A, Mensink RP, Onning G. Changes in serum lipids and postprandial glucose and insulin concentrations after consumption of beverages with beta-glucans from oats or barley: a randomised dose-controlled trial. Eur J Clin Nutr. 2005 Nov;59(11):1272-81. doi: 10.1038/sj.ejcn.1602240.
PubMed 16015250Casiraghi MC, Garsetti M, Testolin G, Brighenti F. Post-prandial responses to cereal products enriched with barley beta-glucan. J Am Coll Nutr. 2006 Aug;25(4):313-20. doi: 10.1080/07315724.2006.10719541.
PubMed 16943453Chillo S, Ranawana DV, Pratt M, Henry CJ. Glycemic response and glycemic index of semolina spaghetti enriched with barley beta-glucan. Nutrition. 2011 Jun;27(6):653-8. doi: 10.1016/j.nut.2010.07.003. Epub 2010 Sep 24.
PubMed 20869206de Graaf C, Blom WA, Smeets PA, Stafleu A, Hendriks HF. Biomarkers of satiation and satiety. Am J Clin Nutr. 2004 Jun;79(6):946-61. doi: 10.1093/ajcn/79.6.946.
PubMed 15159223Poppitt SD, van Drunen JD, McGill AT, Mulvey TB, Leahy FE. Supplementation of a high-carbohydrate breakfast with barley beta-glucan improves postprandial glycaemic response for meals but not beverages. Asia Pac J Clin Nutr. 2007;16(1):16-24.
PubMed 17215176Thondre PS, Henry CJ. Effect of a low molecular weight, high-purity beta-glucan on in vitro digestion and glycemic response. Int J Food Sci Nutr. 2011 Nov;62(7):678-84. doi: 10.3109/09637486.2011.566849. Epub 2011 May 12.
PubMed 21561391Thondre PS, Wang K, Rosenthal AJ, Henry CJ. Glycaemic response to barley porridge varying in dietary fibre content. Br J Nutr. 2012 Mar;107(5):719-24. doi: 10.1017/S0007114511003461. Epub 2011 Jul 26.
PubMed 21787456Tosh SM. Review of human studies investigating the post-prandial blood-glucose lowering ability of oat and barley food products. Eur J Clin Nutr. 2013 Apr;67(4):310-7. doi: 10.1038/ejcn.2013.25. Epub 2013 Feb 20.
PubMed 23422921Canadian Diabetes Association. Canadian diabetes association 2008 clinical practice guidelines for the prevention and management of diabetes in Canada. Canadian Journal of Diabetes. 2008;32(1).
Canadian Diabetes Association Clinical Practice Guidelines Expert Committee; Cheng AY. Canadian Diabetes Association 2013 clinical practice guidelines for the prevention and management of diabetes in Canada. Introduction. Can J Diabetes. 2013 Apr;37 Suppl 1:S1-3. doi: 10.1016/j.jcjd.2013.01.009. Epub 2013 Mar 26. No abstract available.
PubMed 24070926Health Canada. Summary of health Canada's assessment of a health claim about barley products and blood cholesterol lowering. [Internet].; 2012. Available from: http://www.hc-sc.gc.ca/fn-an/label-etiquet/claims-reclam/assess-evalu/barley-orge-eng.php.
EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA). Guidance on the scientific requirements for health claims related to appetite ratings, weight management, and blood glucose concentrations. EFSA J. 2012 Mar 21;10(3):2604. doi: 10.2903/j.efsa.2012.2604. eCollection 2012 Mar. No abstract available.
PubMed 42112026
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-response, Double-blind, Randomized, Controlled, Cross-over Trial Examining the Effect of Barley Beta-glucan on Post-prandial Glucose Response in Healthy Adults
- ClinicalTrials.gov ID
- NCT02367989
- Acronym / sponsor ID
- 1333
- Conditions
- Healthy
- Keywords
- Glucose response, Insulin response, Satiety
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (actual)
- Lead sponsor
- St. Boniface HospitalUniversity, hospital or other
- Collaborators
- Agriculture and Agri-Food Canada
- Study start
- 8 Nov 2017 (actual)
- Primary completion
- 29 Aug 2018 (actual)
- Study completion
- Jan 2025 (estimated)
- First posted
- 20 Feb 2015 (estimated)
- 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.
Lifestyle modifications that include a diet high in fibre may lower the risk of developing type 2 diabetes (CDA, 2013). In this context, the presence of soluble dietary fibre in carbohydrate rich foods has been widely recognized for its effect on post-prandial glucose response (PPGR). Among these, oat and barley derived β-glucan have received tremendous attention for their biological effects, including their ability to reduce PPGR in a wide variety of food matrices (Poppitt et al, 2007). A health claim for PPGR would increase market demand for food grade barley, and help those who want to limit the rise in blood sugar after a meal choose products to meet their goals, but there are several gaps in the literature that need to be filled before a submission to Health Canada can be successful: 1) test foods in appropriate serving sizes; 2) test both the glucose and insulin response; 3) include a reference product that matches in total fibre, macronutrient, and energy profile; 4) perform dose response. The proposed study design will address all of these gaps in the current literature and take into consideration Health Canada's guidance document for health claims related to the reduction in PPGR, which sets out the criteria by which the validity of such claims will be assessed.
Hypothesis:
Barley β-glucan will reduce the PPGR in healthy participants in a dose dependent manner.
Specific objectives:
- To determine the minimum and most effective dose of barley β-glucan in waffles on PPGR and insulin response in a cross-over, randomized, controlled clinical trial.
- To assess the effect of barley β-glucan in waffles on appetite-related sensations using visual analog scales.
- To demonstrate whether the test and reference products were liked or disliked similarly by participants.
- To assess any gastrointestinal side effects from eating the test products
Detailed description
A double-blind, randomized, controlled, cross-over study designed to examine the PPGR to barley β-glucan will be conducted at the I.H. Asper Clinical Research Institute in Winnipeg, Manitoba. A total of 24 healthy volunteers will participate in the trial. Eligible participants who have provided consent will be asked to attend 5 clinic visits in a fasted state. At each visit hey will be given 1 set of waffles to eat that contains either 0g, 2g, 4g, or 6g of barley β-glucan, 7 finger pokes to collect capillary blood, 5 questionnaires about their appetite and a questionnaire about the acceptability of the quick bread. Each visit will last approximately 2.5h and be separated by 3-14 days.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Control without fibre | Placebo comparator | Dietary Supplement: 0g barley β-glucan no fibreIntervention: 0g barley β-glucan no fibre. Dose provided in waffles given as breakfast to fasting participant at 1 of 5 visits. |
| low barley β-glucan | Experimental | Dietary Supplement: 2g barley β-glucanIntervention: 2g barley β-glucan Dose provided in waffles given as breakfast to fasting participant at 1 of 5 visits. |
| medium barley β-glucan | Experimental | Dietary Supplement: 4g barley β-glucanIntervention: 4g barley β-glucan Dose provided in waffles given as breakfast to fasting participant at 1 of 5 visits. |
| high barley β-glucan | Experimental | Dietary Supplement: 6g barley β-glucanIntervention: 6g barley β-glucan Dose provided in waffles given as breakfast to fasting participant at 1 of 5 visits. |
| control with fibre | Placebo comparator | Dietary Supplement: 0g barley β-glucan with fibreIntervention: 0g barley β-glucan with fibre Dose provided in waffles given as breakfast to fasting participant at 1 of 5 visits. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Generally healthy male or female, between the age of 18-40 years;
- Body mass index (BMI) 18.5-30.0 kg/m2;
- Habitually consume breakfast, lunch and dinner in the morning, mid-day and evening, respectively;
- Willing to provide informed consent;
- Willing/able to comply with the requirements of the study.
Key exclusion criteria (22 listed)
- Pregnant or lactating;
- Medical history of diabetes mellitus, fasting plasma glucose ≥7.0 mmol/L, HbA1c ≥6.0%, or use of insulin or oral medication to control blood sugar;
- Medical history of cardiovascular disease;
- Systolic blood pressure >140 mm Hg or diastolic blood pressure >90 mm Hg;
- Fasting plasma total cholesterol >7.8 mmol/L;
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 |
|---|---|---|
| 0g barley β-glucan no fibreFood containing no barley β-glucan and no additional fibre | Dietary supplement | Control without fibre |
| 2g barley β-glucanFood containing low amounts of barley β-glucan | Dietary supplement | low barley β-glucan |
| 4g barley β-glucanFood containing medium amounts of barley β-glucan | Dietary supplement | medium barley β-glucan |
| 6g barley β-glucanFood containing high amounts of barley β-glucan | Dietary supplement | high barley β-glucan |
| 0g barley β-glucan with fibreFood containing no barley β-glucan, but matches fibre content in β-glucan treatments | Dietary supplement | control with fibre |
Primary outcome
Post-prandial glucose response
Time frame: 120 minutes
Incremental area under the curve for glucose (mmol*min/L)
Post-prandial insulin response
Time frame: 120 min
Incremental area under the curve for insulin (uIU*min/mL)
4 secondary outcomes
hunger
Time frame: 120 min
fullness
Time frame: 120 min
desire to eat
Time frame: 120 min
prospective consumption
Time frame: 120 min
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Background: PubMed 18492863Ames NP, Rhymer CR. Issues surrounding health claims for barley. J Nutr. 2008 Jun;138(6):1237S-43S. doi: 10.1093/jn/138.6.1237S.
- Background: PubMed 23761481Aziz A, Dumais L, Barber J. Health Canada's evaluation of the use of glycemic index claims on food labels. Am J Clin Nutr. 2013 Aug;98(2):269-74. doi: 10.3945/ajcn.113.061770. Epub 2013 Jun 12.
- Background: PubMed 16015250Biorklund M, van Rees A, Mensink RP, Onning G. Changes in serum lipids and postprandial glucose and insulin concentrations after consumption of beverages with beta-glucans from oats or barley: a randomised dose-controlled trial. Eur J Clin Nutr. 2005 Nov;59(11):1272-81. doi: 10.1038/sj.ejcn.1602240.
- Background: PubMed 16943453Casiraghi MC, Garsetti M, Testolin G, Brighenti F. Post-prandial responses to cereal products enriched with barley beta-glucan. J Am Coll Nutr. 2006 Aug;25(4):313-20. doi: 10.1080/07315724.2006.10719541.
- Background: PubMed 20869206Chillo S, Ranawana DV, Pratt M, Henry CJ. Glycemic response and glycemic index of semolina spaghetti enriched with barley beta-glucan. Nutrition. 2011 Jun;27(6):653-8. doi: 10.1016/j.nut.2010.07.003. Epub 2010 Sep 24.
- Background: PubMed 15159223de Graaf C, Blom WA, Smeets PA, Stafleu A, Hendriks HF. Biomarkers of satiation and satiety. Am J Clin Nutr. 2004 Jun;79(6):946-61. doi: 10.1093/ajcn/79.6.946.
- Background: PubMed 17215176Poppitt SD, van Drunen JD, McGill AT, Mulvey TB, Leahy FE. Supplementation of a high-carbohydrate breakfast with barley beta-glucan improves postprandial glycaemic response for meals but not beverages. Asia Pac J Clin Nutr. 2007;16(1):16-24.
- Background: PubMed 21561391Thondre PS, Henry CJ. Effect of a low molecular weight, high-purity beta-glucan on in vitro digestion and glycemic response. Int J Food Sci Nutr. 2011 Nov;62(7):678-84. doi: 10.3109/09637486.2011.566849. Epub 2011 May 12.
- Background: PubMed 21787456Thondre PS, Wang K, Rosenthal AJ, Henry CJ. Glycaemic response to barley porridge varying in dietary fibre content. Br J Nutr. 2012 Mar;107(5):719-24. doi: 10.1017/S0007114511003461. Epub 2011 Jul 26.
- Background: PubMed 23422921Tosh SM. Review of human studies investigating the post-prandial blood-glucose lowering ability of oat and barley food products. Eur J Clin Nutr. 2013 Apr;67(4):310-7. doi: 10.1038/ejcn.2013.25. Epub 2013 Feb 20.
- BackgroundCanadian Diabetes Association. Canadian diabetes association 2008 clinical practice guidelines for the prevention and management of diabetes in Canada. Canadian Journal of Diabetes. 2008;32(1).
- Background: PubMed 24070926Canadian Diabetes Association Clinical Practice Guidelines Expert Committee; Cheng AY. Canadian Diabetes Association 2013 clinical practice guidelines for the prevention and management of diabetes in Canada. Introduction. Can J Diabetes. 2013 Apr;37 Suppl 1:S1-3. doi: 10.1016/j.jcjd.2013.01.009. Epub 2013 Mar 26. No abstract available.
- 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.
Heather Blewett, PhD principal investigator
Agriculture and Agri-Food Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0g barley β-glucan no fibre, 2g barley β-glucan and 4g barley β-glucan in people with Healthy, run by St. Boniface Hospital at 1 site in Canada.
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 5 inclusion and 22 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: under way, not looking for participants, as of the sponsor's last update on 29 Nov 2024. 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 Canada. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Post-prandial glucose response (time frame: 120 minutes). The study lists 2 primary outcomes in all. 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 NCT02367989, which also lists 14 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 29 Nov 2024.