NCT02400450

Designer Functional Foods on Parameters of Metabolic and Vascular in Prediabetes

Assessment of Designer Functional Foods on Parameters of Metabolic and Vascular Status in Individuals With Prediabetes.

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Manitoba · Academic / Other
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Pre-Diabetes

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Functional Ingredient Group	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	Control Ingredient Group	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.

Timeline

• Start date: 2016-09-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2015-03-27
• Last updated: 2017-02-23

Locations

2 sites across 2 countries: United States, Canada