Type 2 diabetes patients often do not reach desired control of glycemia despite guidance on changing lifestyle and diet as well as the use of conventional anti-diabetic medication. Parallely in recent years, an array of comparative clinical studies have demonstrated the anti-diabetic effect of more than 10 common spices and food products. Objectives: to evaluate whether proposing a choice of spices and foods products with hypoglycemic effect to diabetic patients can help better control diabetes.
Diabetic type II patients would be encouraged to eat what they like within a list of food products with hypoglycemic effect, at a similar dosage and preparation mode than the one in the reference clinical trials. This pilot project will be conducted as a randomized controlled trial with 2 arms over 12 weeks: 1. training patients about hypoglycemic spices and foods alongside their usual anti-diabetic treatment, versus usual anti-diabetic treatment alone. Expected results: Confirmation of the hypothesis that daily consuming spices and foods with hypoglycemic effect to diabetic patients can help better control diabetes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
124
A booklet with 4 common food products, clinically validated against diabetes, with instructions for use will be presented to the diabetic patient. The selected food products have been assessed as anti-diabetic for humans through at least one fair randomized comparative clinical trial, with a follow-up of several weeks or months. While continuing to take his/her standard medication if any, the patient will be encouraged to follow his/her preferences within the established list of foods and spices: he is expected to choose 2 plants from the list and to consume each of them every day during the whole duration of the trial (12weeks).
The control group will receive only lifestyle and dietary recommendations.
Decrease of ≥ 0.5mmol/L in FPG
Percentage of patients in each group reaching a decrease of ≥ 0.5mmol/L in FPG over 12 weeks
Time frame: 12 weeks
Decrease of ≥ 0.5 points of percentage of HbA1c
Percentage of patients in each group reaching a decrease of ≥ 0.5 points of percentage from the baseline value in HbA1c over 12 weeks
Time frame: 12 weeks
Mean change of FPG
Mean change of FPG e.g. differences between baseline values and values at 12 weeks
Time frame: 12 weeks
Target glycemia
Proportion of patients in each group reaching target glycemia over 12 weeks
Time frame: 12 weeks
Weight
Mean change of weight \[kg\] over 12 weeks
Time frame: 12 weeks
Mean change of HbA1c
Mean change of HbA1c e.g. differences between baseline values and values at 12 weeks
Time frame: 12 weeks
Blood pressure
Mean change of systolic and diastolic blood pressure \[mmHg\] over 12 weeks
Time frame: 12 weeks
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