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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
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.
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.
Mayo Clinic
Rochester, Minnesota, United States
St. Boniface General Hospital
Winnipeg, Manitoba, Canada
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.
Time frame: 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.
Time frame: 12 Weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 Weeks
Food Consumption Patterns
Food consumption patterns will be assessed from Baseline Visit (Day 1) to Week 12 (Day 84) using a questionnaire.
Time frame: 12 Weeks