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

Primary Purpose

Type II Diabetes

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Hypoglycemic food group

Control group

About this trial

This is an interventional treatment trial for Type II Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Hypoglycemic food group

Control group

Arm 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.

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

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Mean change of FPG

Mean change of FPG e.g. differences between baseline values and values at 12 weeks

Target glycemia

Proportion of patients in each group reaching target glycemia over 12 weeks

Weight

Mean change of weight [kg] over 12 weeks

Mean change of HbA1c

Mean change of HbA1c e.g. differences between baseline values and values at 12 weeks

Blood pressure

Mean change of systolic and diastolic blood pressure [mmHg] over 12 weeks

Full Information

NCT ID

NCT05272839

First Posted

February 17, 2022

Last Updated

February 28, 2022

Sponsor

Antenna Foundation

Collaborators

Khon Kaen University

1. Study Identification

Unique Protocol Identification Number

NCT05272839

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

April 2022 (Anticipated)

Primary Completion Date

July 2023 (Anticipated)

Study Completion Date

July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Antenna Foundation

Collaborators

Khon Kaen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type II Diabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

At the first visit, patients will be randomly assigned to control group or intervention group.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Hypoglycemic food group

Arm Type

Experimental

Arm Description

Arm Title

Control group

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Hypoglycemic food group

Intervention Description

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).

Intervention Type

Dietary Supplement

Intervention Name(s)

Control group

Intervention Description

The control group will receive only lifestyle and dietary recommendations.

Primary Outcome Measure Information:

Title

Decrease of ≥ 0.5mmol/L in FPG

Description

Percentage of patients in each group reaching a decrease of ≥ 0.5mmol/L in FPG over 12 weeks

Time Frame

12 weeks

Title

Decrease of ≥ 0.5 points of percentage of HbA1c

Description

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

Secondary Outcome Measure Information:

Title

Mean change of FPG

Description

Mean change of FPG e.g. differences between baseline values and values at 12 weeks

Time Frame

12 weeks

Title

Target glycemia

Description

Proportion of patients in each group reaching target glycemia over 12 weeks

Time Frame

12 weeks

Title

Weight

Description

Mean change of weight [kg] over 12 weeks

Time Frame

12 weeks

Title

Mean change of HbA1c

Description

Mean change of HbA1c e.g. differences between baseline values and values at 12 weeks

Time Frame

12 weeks

Title

Blood pressure

Description

Mean change of systolic and diastolic blood pressure [mmHg] over 12 weeks

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Praew Kotruchin, Prof

Phone

+6643366869

kpraew@kku.ac.th

First Name & Middle Initial & Last Name or Official Title & Degree

Anne-Laure Cavin, PhD

Phone

+41 79 259 63 79

alcavin@antenna.ch

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bertrand Graz, MD, MPH

Organizational Affiliation

Antenna Foundation

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

IPD will be kept in a safe location in Khon Kaen University hospital. It will be available in an anonymous manner upon request and after deidentification.

IPD Sharing Time Frame

April 2023 up to April 2033

IPD Sharing Access Criteria

It will be accessible to any researchers or reviewers who might review the data and perhaps perform some new data analysis. The decision will be in the hands of the Principal investigator and colleagues in Khon Kaen University, plus health and ethical authorities following legislation.

Citations:

PubMed Identifier

34899340

Citation

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.

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

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