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

Antenna Foundation

Status: Not yet enrolling

Conditions: Type II Diabetes

Treatments: Dietary Supplement: Hypoglycemic food group; Dietary Supplement: Control group

Study type: Interventional

Funder types: Other

Identifiers

NCT05272839

DiabetesThai22

Details and patient eligibility

About

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.

Full 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.

Enrollment: 124 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes patients with poorly controlled glycemia, i.e. at least one of the following measurements:

  1. 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

1. Severe and unstable complications of diabetes: end-organ damage such as nephropathy, retinopathy, neuropathy, etc...
2. Patients with rapid insulin,
3. Any health condition that requires urgent attention,
4. Patients with a cognitive or sensory impairment that may prevent conducting the interview,
5. HbA1c > 11.5%
6. Pregnant women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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124 participants in 2 patient groups, including a placebo group

Hypoglycemic food group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Hypoglycemic food group

Control group

Placebo Comparator group

Description:

The control group will receive only dietary advice and standard medication if any.

Treatment:

Dietary Supplement: Control group