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

Type II Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05272839
• Other study ID #: DiabetesThai22
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2022
• Est. completion date: July 2024

Study information

• Verified date: February 2022
• Source: Antenna Foundation
• Contact: Praew Kotruchin, Prof
• Phone: +6643366869
• Email: kpraew[@]kku.ac.th
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 124
• Est. completion date: July 2024
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type II Diabetes

Intervention

Dietary Supplement:
• Hypoglycemic food group
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).
• Control group
The control group will receive only lifestyle and dietary recommendations.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Antenna Foundation	Khon Kaen University

References & Publications (1)

Willcox ML, Elugbaju C, Al-Anbaki M, Lown M, Graz B. Effectiveness of Medicinal Plants for Glycaemic Control in Type 2 Diabetes: An Overview of Meta-Analyses of Clinical Trials. Front Pharmacol. 2021 Nov 26;12:777561. doi: 10.3389/fphar.2021.777561. eCollection 2021. Review. — View Citation

Outcome

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