Association Between Natural Hypoglycemic Foods and Blood Sugar Level: A Pilot Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Association Between Natural Hypoglycemic Foods and Blood Sugar Level: A Pilot Study

Conditions
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Type II Diabetes

Intervention / Treatment
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* Dietary Supplement: Hypoglycemic food group
* Dietary Supplement: Control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes patients with poorly controlled glycemia, i.e. at least one of the following measurements: Fasting plasma glucose (FPG) values ≥ 7.0 mmol/L (126 mg/dl), or 2-h post-load plasma glucose ≥ 11.1 mmol/L (200 mg/dl), or HbA1c > 6.5% (48 mmol/mol); or a random blood glucose ≥ 11.1 mmol/L (200 mg/ dl), despite ≥ 3 months usual care (lifestyle + medication if applicable). Exclusion criteria: Severe and unstable complications of diabetes: end-organ damage such as nephropathy, retinopathy, neuropathy, etc... Patients with rapid insulin, Any health condition that requires urgent attention, Patients with a cognitive or sensory impairment that may prevent conducting the interview, HbA1c > 11.5% Pregnant women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: At the first visit, patients will be randomly assigned to control group or intervention group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypoglycemic food group<br>The patient will choose 2 food products clinically validated against diabetes, at the same dosage and the same mode of preparation as in the reference clinical trials. This will be done additionally to healthcare advice and standard medication if any. | Dietary Supplement: Hypoglycemic food group<br>* 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).<br>|
| Placebo Comparator: Control group<br>The control group will receive only dietary advice and standard medication if any. | Dietary Supplement: Control group<br>* The control group will receive only lifestyle and dietary recommendations.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change of FPG | Mean change of FPG e.g. differences between baseline values and values at 12 weeks | 12 weeks | 
| Target glycemia | Proportion of patients in each group reaching target glycemia over 12 weeks | 12 weeks | 
| Weight | Mean change of weight [kg] over 12 weeks | 12 weeks | 
| Mean change of HbA1c | Mean change of HbA1c e.g. differences between baseline values and values at 12 weeks | 12 weeks | 
| Blood pressure | Mean change of systolic and diastolic blood pressure [mmHg] over 12 weeks | 12 weeks |