Pre-Diabetes Clinical Trial
— PREFFER-2014Official title:
Assessment of Designer Functional Foods on Parameters of Metabolic and Vascular Status in Individuals With Prediabetes.
Verified date | February 2017 |
Source | University of Manitoba |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 2017 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 75 Years |
Eligibility |
Inclusion Criteria: Participants must meet the following criteria to be eligible for participation in the study: 1. Male, or non-pregnant, non-lactating females, aged 21 - 75 years; 2. Glycated hemoglobin A1c =6.0% and <7.0%; 3. Body-mass index 18-40; 4. Able to read, write and communicate orally in English; 5. Willing to maintain a stable level of activity during participation in the study; 6. Willing to comply with protocol requirements and procedures; 7. Willing to provide written informed consent. Exclusion Criteria: 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; 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. |
Country | Name | City | State |
---|---|---|---|
Canada | St. Boniface General Hospital | Winnipeg | Manitoba |
United States | Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
University of Manitoba | Manitoba Agri-Health Research Network, Manitoba Science and Technology International Collaboration Fund |
United States, Canada,
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Silva 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. Review. — View Citation
Stringer 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. — View Citation
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* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 12 Weeks | |
Primary | 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. | 12 Weeks | |
Secondary | 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. | 12 Weeks | |
Secondary | Blood Glucose | Assessment of glucose will be completed at Baseline Visit (Day 1), Week 6 (Day 42) and Week 12 visits (Day 84) visits. | 12 Weeks | |
Secondary | 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. | 12 Weeks | |
Secondary | 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. | 12 Weeks | |
Secondary | 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. | 12 Weeks | |
Secondary | 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. | 12 Weeks | |
Secondary | 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. | 12 Weeks | |
Secondary | 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. | Week 12 | |
Secondary | 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. | 12 Weeks | |
Secondary | 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. | 12 Weeks | |
Secondary | Food Consumption Patterns | Food consumption patterns will be assessed from Baseline Visit (Day 1) to Week 12 (Day 84) using a questionnaire. | 12 Weeks |
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