Association Between Natural Hypoglycemic Foods and Blood Sugar Level: A Pilot Study
- Conditions
- Type II Diabetes
- Interventions
- Dietary Supplement: Control groupDietary Supplement: Hypoglycemic food group
- Registration Number
- NCT05272839
- Lead Sponsor
- Antenna Foundation
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 124
-
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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group Control group The control group will receive only dietary advice and standard medication if any. Hypoglycemic food group Hypoglycemic food group 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.
- Primary Outcome Measures
Name Time Method Decrease of ≥ 0.5mmol/L in FPG 12 weeks Percentage of patients in each group reaching a decrease of ≥ 0.5mmol/L in FPG over 12 weeks
Decrease of ≥ 0.5 points of percentage of HbA1c 12 weeks Percentage of patients in each group reaching a decrease of ≥ 0.5 points of percentage from the baseline value in HbA1c over 12 weeks
- Secondary Outcome Measures
Name Time Method Weight 12 weeks Mean change of weight \[kg\] over 12 weeks
Mean change of FPG 12 weeks Mean change of FPG e.g. differences between baseline values and values at 12 weeks
Target glycemia 12 weeks Proportion of patients in each group reaching target glycemia over 12 weeks
Mean change of HbA1c 12 weeks Mean change of HbA1c e.g. differences between baseline values and values at 12 weeks
Blood pressure 12 weeks Mean change of systolic and diastolic blood pressure \[mmHg\] over 12 weeks