Pre-DiabetesPREFFER-2014NCT02400450
Designer Functional Foods on Parameters of Metabolic and Vascular in Prediabetes
A study testing Functional Ingredient Group in people with Pre-Diabetes, run by University of Manitoba at 2 sites in 2 countries.
Trial summary
This is a multi-site, double-blind, randomized, controlled food intervention study being conducted at the Canadian Centre for Agri-Food Research in Health and Medicine (CCARM) in Winnipeg and the Mayo Clinic, Rochester, MN, to examine the effects of a portfolio of functional foods on blood glucose and lipids, and… Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Pre-Diabetes
- What is being tested?
- Functional Ingredient Group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Sep 2016to Dec 2017
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must meet the following criteria to be eligible for participation in the study:
- Male, or non-pregnant, non-lactating females, aged 21 - 75 years;
- Glycated hemoglobin A1c ≥6.0% and <7.0%;
- Body-mass index 18-40;
- Able to read, write and communicate orally in English;
- Willing to maintain a stable level of activity during participation in the study;
- Willing to comply with protocol requirements and procedures;
- Willing to provide written informed consent.
Who cannot join
- Failure to meet any one of the above eligibility criteria will result in an inability to participate in the study. Participants will also be excluded if they have or require any of the following:
- 1 Previous diagnosis of diabetes or taking diabetes medications (glucose-lowering medications, insulin);
- 2. Previous diagnosis of cardiovascular disease (e.g. heart attack, stroke, peripheral artery disease), or taking lipid-lowering medications, or having a surgical procedure/intervention to treat cardiovascular disease (e.g. bypass surgery, stent). [Note that individuals with hypertension and/or taking anti-hypertensive medication are eligible to participate.];
- 3. Fasting LDL-cholesterol >160 mg/dL (>4.1 mmol/L);
- 4. Fasting triglycerides >400 mg/dL (>4.5 mmol/L);
- 5. Serum alanine aminotransferase (ALT) outside the normal range of 7-56 units/L;
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- 6. Serum creatinine outside the normal range of 0.7-1.3 mg/dL for males and 0.6-1.1 mg/dL for females;
- 7. Conditions which affect normal nutrient absorption (e.g. Celiac disease, inflammatory bowel disease);
- 8. Untreated endocrine disorders with the potential to affect glucose and lipid metabolism;
- 9. In the previous 3 months and during the study, consumption of supplements or herbals in amounts that lower blood glucose or blood lipids (e.g. chromium, margarine with plant sterols, high fibre supplements such as Metamucil, cinnamon extract, ginseng, bitter melon, gamma-linolenic acid);
- 10. Food allergies or intolerances which severely limit the variety of study food products that can be consumed;
- 11. Eating philosophies or eating patterns that would limit or not include consumption of the study foods;
- 12. Any acute medical condition or surgical intervention within the past 3 months;
- 13. Conditions or medications which are likely to increase the risk to the participants or study personnel, or to reduce the ability of the participant to comply with the protocol, or affect the results;
- 14. Currently participating in or having participated in a food intervention study within the last month;
- 15. Inability to adhere to the study protocol;
- 16. Unable to obtain blood sample at the screening and/or baseline visit.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Assessment of Designer Functional Foods on Parameters of Metabolic and Vascular Status in Individuals With Prediabetes.
This is a multi-site, double-blind, randomized, controlled food intervention study being conducted at the Canadian Centre for Agri-Food Research in Health and Medicine (CCARM) in Winnipeg and the Mayo Clinic, Rochester, MN, to examine the effects of a portfolio of functional foods on blood glucose and lipids, and blood vessel function in individuals with prediabetes.
A total of 116 participants (n=58/site) with prediabetes (hemoglobin A1c ≥6.0 \& <7.0 and no glucose-lowering medications) and body-mass index (BMI) 18-40 will be recruited for a 12-week clinical trial to determine the effect of eating 2 items containing functional ingredients daily compared to 2 similar items lacking the functional ingredients. Study foods provided are to be incorporated into participant's usual diet.
Read the detailed description
This study will investigate the effect of a 12 week intervention with a portfolio of 7 food products and 7 comparator products for their effect on glycated hemoglobin, blood lipids, blood vessel function and metabolic parameters in persons with prediabetes. Prediabetes precedes the manifestation of type 2 diabetes and is therefore an appropriate target for dietary interventions. It is also associated with increased cardiovascular disease (CVD) risk because of the presence of abdominal obesity, elevated LDL-cholesterol and reduced vascular function. CVD risk will be assessed based on the profile of lipids and other factors in the blood as well using specialized equipment for non-invasive monitoring of blood vessel function.
If the foods prove beneficial for managing blood glucose levels, the publication of results in scientific journals and in lay documents will increase awareness and provide important information of the health benefits of these products for consumers, health professionals and the food industry. It will also help individuals who may be able to manage their illnesses in a healthful non-pharmaceutical nutritional approach and who may benefit from physician-prescribed nutritional counseling with a focus on foods known to improve certain disease biomarkers. At this time these approaches lack practicality and direct application to individuals who are interested in adopting a new dietary regime capable of disease prevention.
- Conditions
- Pre-Diabetes
- Being tested
- Functional Ingredient Group, Control Ingredient Group
- Keywords
- Pre-diabetes, prediabetes, glycated hemoglobin, hemoglobin A1c, LDL cholesterol, Cholesterol, metabolic function, vascular function, functional food
- Medical subject headings
- Glucose Intolerance, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Ingredient GroupDietary supplement
Also called Step One Foods (TruHealthMD)
Participants will be provided with a mix of 6 study products to use over the 12 week trial (2 per day). These will be a) oatmeal, b) pancake mix, c) chocolate crunch bar, d) cranberry nut bar, e) anytime sprinkle, and f) smoothie mix, standardized for the content of functional ingredients.
Control Ingredient GroupDietary supplement
The control group will receive a comparable set of food items to use over the 12 week trial (2 per day). These food items will contain an equivalent amount of calories per portion but without the additional functional ingredients.
| Study group | Role | What they receive |
|---|---|---|
| Functional Ingredient Group | Experimental | Participants will be provided with a mix of 6 study products to use over the 12 week trial (2 per day). These will be a) oatmeal, b) pancake mix, c) chocolate crunch bar, d) cranberry nut bar, e) anytime sprinkle, and f) smoothie mix. The food items will contain a standardized amount of functional ingredients. Receives: Dietary Supplement: Functional Ingredient Group |
| Control Ingredient Group | Placebo comparator | The control group will receive a comparable set of food items that contain an equivalent amount of calories per portion but without the added functional ingredients. Receives: Dietary Supplement: Control Ingredient Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycated Hemoglobin (A1c)
Assessments of glycated hemoglobin will be completed at Baseline Visit (Day 1), Week 6 (Day 42) and Week 12 visits (Day 84) visits.
Measured: 12 Weeks
LDL-Cholesterol
Assessments of LDL-Cholesterol will be completed at Baseline Visit (Day 1), Week 6 (Day 42) and Week 12 visits (Day 84) visits.
Measured: 12 Weeks
Secondary outcomes (11)
Blood Lipids (Total Cholesterol, HDL-Cholesterol, and Triglycerides)
Assessment of blood lipid profile will be completed at Baseline Visit (Day 1), Week 6 (Day 42) and Week 12 visits (Day 84) visits.
Measured: 12 Weeks
Blood Glucose
Assessment of glucose will be completed at Baseline Visit (Day 1), Week 6 (Day 42) and Week 12 visits (Day 84) visits.
Measured: 12 Weeks
Insulin
Assessment of insulin (and calculation of insulin sensitivity using HOMA-IR, QUICKI) will be completed at Baseline Visit (Day 1), Week 6 (Day 42) and Week 12 visits (Day 84) visits.
Measured: 12 Weeks
C-Reactive Protein
Assessment of C-Reactive Protein will be completed at Baseline Visit (Day 1), Week 6 (Day 42) and Week 12 visits (Day 84) visits.
Measured: 12 Weeks
Advanced Glycation End-products (AGE)
Assessment of advanced glycated endproducts (AGEs) using a non-invasive skin fluorescence device (AGE Reader from Diagnotipics Inc.) will be completed at Baseline Visit (Day 1), Week 6 (Day 42) and Week 12 visits (Day 84) visits.
Measured: 12 Weeks
Pulse Wave Analysis/Velocity (Blood Vessel Function)
Assessment of blood vessel function (arterial compliance) via pulse-wave analysis and pulse wave velocity will be performed at the Baseline Visit (Day 1), Week 6 (Day 56) and Week 12 (Day 84) visits.
Measured: 12 Weeks
Biomarkers of Vascular Function
Assessment of biomarkers of vascular function in acquired blood samples will be completed at Baseline Visit (Day 1), Week 6 (Day 42) and Week 12 visits (Day 84) visits.
Measured: 12 Weeks
Biomarkers of Inflammation, Oxidative Stress, Immune Function and Metabolism
Assessment of inflammation, oxidative stress, immune function and metabolism from acquired blood samples will be completed at Baseline Visit (Day 1), Week 6 (Day 42) and Week 12 visits (Day 84) visits.
Measured: Week 12
Changes in composite measure of Anthropometrics
Changes in anthropometrics, specifically weight, body mass index, waist and hip circumference will be compared to the Baseline Visit (Day 1) and will be acquired at the Week 6 (Day 56) and Week 12 (Day 84) visits. Changes in body fat composition as assessed via dual-energy x-ray absorptiometry (DEXA)) will be assesed at the Baseline Visit (Day 1) and Week 12 (Day 84) visit.
Measured: 12 Weeks
Blood Pressure
Blood pressure will be measure and assessed for changes at the Baseline (Day 1), Week 6 (Day 56) and Week 12 (Day 84) visit.
Measured: 12 Weeks
Food Consumption Patterns
Food consumption patterns will be assessed from Baseline Visit (Day 1) to Week 12 (Day 84) using a questionnaire.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2015 (estimated)
- Study startSep 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Pre-DiabetesStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Manitoba Science and Technology International Collaboration Fund, Manitoba Agri-Health Research Network
- Responsible party
- Principal investigator, Dr. Carla Taylor, University of Manitoba
- Investigators
- Carla Taylor, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02400450
- Sponsor's protocol ID
- B2014:041
- Acronym
- PREFFER-2014
- Status last verified
- Feb 2017
- First submitted
- 11 Feb 2015
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Lindstrom J, Louheranta A, Mannelin M, Rastas M, Salminen V, Eriksson J, Uusitupa M, Tuomilehto J; Finnish Diabetes Prevention Study Group. The Finnish Diabetes Prevention Study (DPS): Lifestyle intervention and 3-year results on diet and physical activity. Diabetes Care. 2003 Dec;26(12):3230-6. doi: 10.2337/diacare.26.12.3230.
PubMed 14633807Diabetes Prevention Program Research Group; Knowler WC, Fowler SE, Hamman RF, Christophi CA, Hoffman HJ, Brenneman AT, Brown-Friday JO, Goldberg R, Venditti E, Nathan DM. 10-year follow-up of diabetes incidence and weight loss in the Diabetes Prevention Program Outcomes Study. Lancet. 2009 Nov 14;374(9702):1677-86. doi: 10.1016/S0140-6736(09)61457-4. Epub 2009 Oct 29.
PubMed 19878986Silva FM, Kramer CK, de Almeida JC, Steemburgo T, Gross JL, Azevedo MJ. Fiber intake and glycemic control in patients with type 2 diabetes mellitus: a systematic review with meta-analysis of randomized controlled trials. Nutr Rev. 2013 Dec;71(12):790-801. doi: 10.1111/nure.12076. Epub 2013 Nov 1.
PubMed 24180564Hlebowicz J, Drake I, Gullberg B, Sonestedt E, Wallstrom P, Persson M, Nilsson J, Hedblad B, Wirfalt E. A high diet quality is associated with lower incidence of cardiovascular events in the Malmo diet and cancer cohort. PLoS One. 2013 Aug 5;8(8):e71095. doi: 10.1371/journal.pone.0071095. Print 2013.
PubMed 23940694Deng R. A review of the hypoglycemic effects of five commonly used herbal food supplements. Recent Pat Food Nutr Agric. 2012 Apr 1;4(1):50-60. doi: 10.2174/2212798411204010050.
PubMed 22329631Lee T, Dugoua JJ. Nutritional supplements and their effect on glucose control. Adv Exp Med Biol. 2012;771:381-95. doi: 10.1007/978-1-4614-5441-0_27.
PubMed 23393691Shane-McWhorter L. Dietary supplements and probiotics for diabetes. Am J Nurs. 2012 Jul;112(7):47-53. doi: 10.1097/01.NAJ.0000415961.92674.d4.
PubMed 22739611Suksomboon N, Poolsup N, Boonkaew S, Suthisisang CC. Meta-analysis of the effect of herbal supplement on glycemic control in type 2 diabetes. J Ethnopharmacol. 2011 Oct 11;137(3):1328-33. doi: 10.1016/j.jep.2011.07.059. Epub 2011 Aug 5.
PubMed 21843614Perera PK, Li Y. Functional herbal food ingredients used in type 2 diabetes mellitus. Pharmacogn Rev. 2012 Jan;6(11):37-45. doi: 10.4103/0973-7847.95863.
PubMed 22654403Thondre PS. Food-based ingredients to modulate blood glucose. Adv Food Nutr Res. 2013;70:181-227. doi: 10.1016/B978-0-12-416555-7.00005-9.
PubMed 23722097Cheng DM, Kuhn P, Poulev A, Rojo LE, Lila MA, Raskin I. In vivo and in vitro antidiabetic effects of aqueous cinnamon extract and cinnamon polyphenol-enhanced food matrix. Food Chem. 2012 Dec 15;135(4):2994-3002. doi: 10.1016/j.foodchem.2012.06.117. Epub 2012 Jul 14.
PubMed 22980902Pawar K, Thompkinson DK. Multiple functional ingredient approach in formulating dietary supplement for management of diabetes: a review. Crit Rev Food Sci Nutr. 2014;54(7):957-73. doi: 10.1080/10408398.2011.621039.
PubMed 24499073Vinik AI. A medicinal food provides food for thought in managing diabetic neuropathy. Am J Med. 2013 Feb;126(2):95-6. doi: 10.1016/j.amjmed.2012.08.008. No abstract available.
PubMed 23331432Stringer DM, Taylor CG, Appah P, Blewett H, Zahradka P. Consumption of buckwheat modulates the post-prandial response of selected gastrointestinal satiety hormones in individuals with type 2 diabetes mellitus. Metabolism. 2013 Jul;62(7):1021-31. doi: 10.1016/j.metabol.2013.01.021. Epub 2013 Feb 26.
PubMed 23485142Welch RW, Antoine JM, Berta JL, Bub A, de Vries J, Guarner F, Hasselwander O, Hendriks H, Jakel M, Koletzko BV, Patterson CC, Richelle M, Skarp M, Theis S, Vidry S, Woodside JV; International Life Sciences Institute Europe Functional Foods Task Force. Guidelines for the design, conduct and reporting of human intervention studies to evaluate the health benefits of foods. Br J Nutr. 2011 Nov;106 Suppl 2:S3-15. doi: 10.1017/S0007114511003606.
PubMed 22129662
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Designer Functional Foods on Parameters of Metabolic and Vascular Status in Individuals With Prediabetes.
- ClinicalTrials.gov ID
- NCT02400450
- Acronym / sponsor ID
- PREFFER-2014 / B2014:041
- Conditions
- Pre-Diabetes
- Keywords
- Pre-diabetes, prediabetes, glycated hemoglobin, hemoglobin A1c, LDL cholesterol, Cholesterol, metabolic function, vascular function
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Manitoba Science and Technology International Collaboration Fund, Manitoba Agri-Health Research Network
- Study start
- Sep 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 27 Mar 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.
This is a multi-site, double-blind, randomized, controlled food intervention study being conducted at the Canadian Centre for Agri-Food Research in Health and Medicine (CCARM) in Winnipeg and the Mayo Clinic, Rochester, MN, to examine the effects of a portfolio of functional foods on blood glucose and lipids, and blood vessel function in individuals with prediabetes.
A total of 116 participants (n=58/site) with prediabetes (hemoglobin A1c ≥6.0 \& <7.0 and no glucose-lowering medications) and body-mass index (BMI) 18-40 will be recruited for a 12-week clinical trial to determine the effect of eating 2 items containing functional ingredients daily compared to 2 similar items lacking the functional ingredients. Study foods provided are to be incorporated into participant's usual diet.
Detailed description
This study will investigate the effect of a 12 week intervention with a portfolio of 7 food products and 7 comparator products for their effect on glycated hemoglobin, blood lipids, blood vessel function and metabolic parameters in persons with prediabetes. Prediabetes precedes the manifestation of type 2 diabetes and is therefore an appropriate target for dietary interventions. It is also associated with increased cardiovascular disease (CVD) risk because of the presence of abdominal obesity, elevated LDL-cholesterol and reduced vascular function. CVD risk will be assessed based on the profile of lipids and other factors in the blood as well using specialized equipment for non-invasive monitoring of blood vessel function.
If the foods prove beneficial for managing blood glucose levels, the publication of results in scientific journals and in lay documents will increase awareness and provide important information of the health benefits of these products for consumers, health professionals and the food industry. It will also help individuals who may be able to manage their illnesses in a healthful non-pharmaceutical nutritional approach and who may benefit from physician-prescribed nutritional counseling with a focus on foods known to improve certain disease biomarkers. At this time these approaches lack practicality and direct application to individuals who are interested in adopting a new dietary regime capable of disease prevention.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional Ingredient Group | Experimental | Dietary Supplement: Functional Ingredient GroupParticipants will be provided with a mix of 6 study products to use over the 12 week trial (2 per day). These will be a) oatmeal, b) pancake mix, c) chocolate crunch bar, d) cranberry nut bar, e) anytime sprinkle, and f) smoothie mix. The food items will contain a standardized amount of functional ingredients. |
| Control Ingredient Group | Placebo comparator | Dietary Supplement: Control Ingredient GroupThe control group will receive a comparable set of food items that contain an equivalent amount of calories per portion but without the added functional ingredients. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participants must meet the following criteria to be eligible for participation in the study:
- Male, or non-pregnant, non-lactating females, aged 21 - 75 years;
- Glycated hemoglobin A1c ≥6.0% and <7.0%;
- Body-mass index 18-40;
- Able to read, write and communicate orally in English;
Key exclusion criteria (17 listed)
- Failure to meet any one of the above eligibility criteria will result in an inability to participate in the study. Participants will also be excluded if they have or require any of the following:
- 1 Previous diagnosis of diabetes or taking diabetes medications (glucose-lowering medications, insulin);
- 2. Previous diagnosis of cardiovascular disease (e.g. heart attack, stroke, peripheral artery disease), or taking lipid-lowering medications, or having a surgical procedure/intervention to treat cardiovascular disease (e.g. bypass surgery, stent). [Note that individuals with hypertension and/or taking anti-hypertensive medication are eligible to participate.];
- 3. Fasting LDL-cholesterol >160 mg/dL (>4.1 mmol/L);
- 4. Fasting triglycerides >400 mg/dL (>4.5 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 |
|---|---|---|
| Functional Ingredient GroupAlso: Step One Foods (TruHealthMD)Participants will be provided with a mix of 6 study products to use over the 12 week trial (2 per day). These will be a) oatmeal, b) pancake mix, c) chocolate crunch bar, d) cranberry nut bar, e) anytime sprinkle, and f) smoothie mix, standardized for the content of functional ingredients. | Dietary supplement | Functional Ingredient Group |
| Control Ingredient GroupThe control group will receive a comparable set of food items to use over the 12 week trial (2 per day). These food items will contain an equivalent amount of calories per portion but without the additional functional ingredients. | Dietary supplement | Control Ingredient Group |
Primary outcome
Glycated Hemoglobin (A1c)
Time frame: 12 Weeks
Assessments of glycated hemoglobin will be completed at Baseline Visit (Day 1), Week 6 (Day 42) and Week 12 visits (Day 84) visits.
LDL-Cholesterol
Time frame: 12 Weeks
Assessments of LDL-Cholesterol will be completed at Baseline Visit (Day 1), Week 6 (Day 42) and Week 12 visits (Day 84) visits.
11 secondary outcomes
Blood Lipids (Total Cholesterol, HDL-Cholesterol, and Triglycerides)
Time frame: 12 Weeks
Blood Glucose
Time frame: 12 Weeks
Insulin
Time frame: 12 Weeks
C-Reactive Protein
Time frame: 12 Weeks
Advanced Glycation End-products (AGE)
Time frame: 12 Weeks
Pulse Wave Analysis/Velocity (Blood Vessel Function)
Time frame: 12 Weeks
Biomarkers of Vascular Function
Time frame: 12 Weeks
Biomarkers of Inflammation, Oxidative Stress, Immune Function and Metabolism
Time frame: Week 12
Changes in composite measure of Anthropometrics
Time frame: 12 Weeks
Blood Pressure
Time frame: 12 Weeks
Food Consumption Patterns
Time frame: 12 Weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Background: PubMed 14633807Lindstrom J, Louheranta A, Mannelin M, Rastas M, Salminen V, Eriksson J, Uusitupa M, Tuomilehto J; Finnish Diabetes Prevention Study Group. The Finnish Diabetes Prevention Study (DPS): Lifestyle intervention and 3-year results on diet and physical activity. Diabetes Care. 2003 Dec;26(12):3230-6. doi: 10.2337/diacare.26.12.3230.
- Background: PubMed 19878986Diabetes Prevention Program Research Group; Knowler WC, Fowler SE, Hamman RF, Christophi CA, Hoffman HJ, Brenneman AT, Brown-Friday JO, Goldberg R, Venditti E, Nathan DM. 10-year follow-up of diabetes incidence and weight loss in the Diabetes Prevention Program Outcomes Study. Lancet. 2009 Nov 14;374(9702):1677-86. doi: 10.1016/S0140-6736(09)61457-4. Epub 2009 Oct 29.
- Background: PubMed 24180564Silva FM, Kramer CK, de Almeida JC, Steemburgo T, Gross JL, Azevedo MJ. Fiber intake and glycemic control in patients with type 2 diabetes mellitus: a systematic review with meta-analysis of randomized controlled trials. Nutr Rev. 2013 Dec;71(12):790-801. doi: 10.1111/nure.12076. Epub 2013 Nov 1.
- Background: PubMed 23940694Hlebowicz J, Drake I, Gullberg B, Sonestedt E, Wallstrom P, Persson M, Nilsson J, Hedblad B, Wirfalt E. A high diet quality is associated with lower incidence of cardiovascular events in the Malmo diet and cancer cohort. PLoS One. 2013 Aug 5;8(8):e71095. doi: 10.1371/journal.pone.0071095. Print 2013.
- Background: PubMed 22329631Deng R. A review of the hypoglycemic effects of five commonly used herbal food supplements. Recent Pat Food Nutr Agric. 2012 Apr 1;4(1):50-60. doi: 10.2174/2212798411204010050.
- Background: PubMed 23393691Lee T, Dugoua JJ. Nutritional supplements and their effect on glucose control. Adv Exp Med Biol. 2012;771:381-95. doi: 10.1007/978-1-4614-5441-0_27.
- Background: PubMed 22739611Shane-McWhorter L. Dietary supplements and probiotics for diabetes. Am J Nurs. 2012 Jul;112(7):47-53. doi: 10.1097/01.NAJ.0000415961.92674.d4.
- Background: PubMed 21843614Suksomboon N, Poolsup N, Boonkaew S, Suthisisang CC. Meta-analysis of the effect of herbal supplement on glycemic control in type 2 diabetes. J Ethnopharmacol. 2011 Oct 11;137(3):1328-33. doi: 10.1016/j.jep.2011.07.059. Epub 2011 Aug 5.
- Background: PubMed 22654403Perera PK, Li Y. Functional herbal food ingredients used in type 2 diabetes mellitus. Pharmacogn Rev. 2012 Jan;6(11):37-45. doi: 10.4103/0973-7847.95863.
- Background: PubMed 23722097Thondre PS. Food-based ingredients to modulate blood glucose. Adv Food Nutr Res. 2013;70:181-227. doi: 10.1016/B978-0-12-416555-7.00005-9.
- Background: PubMed 22980902Cheng DM, Kuhn P, Poulev A, Rojo LE, Lila MA, Raskin I. In vivo and in vitro antidiabetic effects of aqueous cinnamon extract and cinnamon polyphenol-enhanced food matrix. Food Chem. 2012 Dec 15;135(4):2994-3002. doi: 10.1016/j.foodchem.2012.06.117. Epub 2012 Jul 14.
- Background: PubMed 24499073Pawar K, Thompkinson DK. Multiple functional ingredient approach in formulating dietary supplement for management of diabetes: a review. Crit Rev Food Sci Nutr. 2014;54(7):957-73. doi: 10.1080/10408398.2011.621039.
- Canadian Centre for Agri-Food Research in Health and MedicineLink provided by the sponsor.
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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.
Carla Taylor, PhD principal investigator
University of Manitoba
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Ingredient Group in people with Pre-Diabetes, run by University of Manitoba at 2 sites in 2 countries.
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 17 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: withdrawn, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Glycated Hemoglobin (A1c) (time frame: 12 Weeks). 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 NCT02400450, which also lists 16 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 23 Feb 2017.