Association Between Natural Hypoglycemic Foods and Blood Sugar Level: A Pilot Study
1 other identifier
interventional
124
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2022
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2022
CompletedFirst Posted
Study publicly available on registry
March 10, 2022
CompletedStudy Start
First participant enrolled
April 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2024
CompletedMarch 10, 2022
February 1, 2022
1.2 years
February 17, 2022
February 28, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (5)
Mean change of FPG
12 weeks
Target glycemia
12 weeks
Weight
12 weeks
Mean change of HbA1c
12 weeks
Blood pressure
12 weeks
Study Arms (2)
Hypoglycemic food group
EXPERIMENTALThe 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.
Control group
PLACEBO COMPARATORThe control group will receive only dietary advice and standard medication if any.
Interventions
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).
The control group will receive only lifestyle and dietary recommendations.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Antenna Foundationlead
- Khon Kaen Universitycollaborator
Related 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.
PMID: 34899340BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bertrand Graz, MD, MPH
Antenna Foundation
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2022
First Posted
March 10, 2022
Study Start
April 1, 2022
Primary Completion
July 1, 2023
Study Completion
July 1, 2024
Last Updated
March 10, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- April 2023 up to April 2033
- 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.
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.