Pre-Diabetes Clinical Trial
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.
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.
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