Designer Functional Foods on Parameters of Metabolic and Vascular in Prediabetes

Withdrawn before enrolling · Not applicable

Conditions studied: Pre-Diabetes

In brief

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.

Key facts

Study ID

NCT02400450

Run by

University of Manitoba

People needed

0

Starts

2016-09-01

Expected to finish

2017-12-01

Last updated by the study team

2017-02-23

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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);
• 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.];
• Fasting LDL-cholesterol >160 mg/dL (>4.1 mmol/L);
• Fasting triglycerides >400 mg/dL (>4.5 mmol/L);
• Serum alanine aminotransferase (ALT) outside the normal range of 7-56 units/L;
• Serum creatinine outside the normal range of 0.7-1.3 mg/dL for males and 0.6-1.1 mg/dL for females;
• Conditions which affect normal nutrient absorption (e.g. Celiac disease, inflammatory bowel disease);
• Untreated endocrine disorders with the potential to affect glucose and lipid metabolism;
• 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);
• Food allergies or intolerances which severely limit the variety of study food products that can be consumed;
• Eating philosophies or eating patterns that would limit or not include consumption of the study foods;
• Any acute medical condition or surgical intervention within the past 3 months;
• 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;
• Currently participating in or having participated in a food intervention study within the last month;
• Inability to adhere to the study protocol;
• Unable to obtain blood sample at the screening and/or baseline visit.

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States
• St. Boniface General Hospital — Winnipeg, Manitoba, Canada

Full record on ClinicalTrials.gov

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