Type II DiabetesNCT05272839
Association Between Natural Hypoglycemic Foods and Blood Sugar Level: A Pilot Study
A study testing Hypoglycemic food group in people with Type II Diabetes, run by Antenna Foundation.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type II Diabetes
- What is being tested?
- Hypoglycemic food group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- No sites listed yet
- Study dates
- Apr 2022to Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Type II Diabetes
- Being tested
- Hypoglycemic food group, Control group
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypoglycemic food groupDietary supplement
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 groupDietary supplement
The control group will receive only lifestyle and dietary recommendations.
| Study group | Role | What they receive |
|---|---|---|
| Hypoglycemic food group | Experimental | 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. Receives: Dietary Supplement: Hypoglycemic food group |
| Control group | Placebo comparator | The control group will receive only dietary advice and standard medication if any. Receives: Dietary Supplement: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 12 weeks
Secondary outcomes (5)
Mean change of FPG
Mean change of FPG e.g. differences between baseline values and values at 12 weeks
Measured: 12 weeks
Target glycemia
Proportion of patients in each group reaching target glycemia over 12 weeks
Measured: 12 weeks
Weight
Mean change of weight [kg] over 12 weeks
Measured: 12 weeks
Mean change of HbA1c
Mean change of HbA1c e.g. differences between baseline values and values at 12 weeks
Measured: 12 weeks
Blood pressure
Mean change of systolic and diastolic blood pressure [mmHg] over 12 weeks
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study startApr 2022 (estimated)
- Primary completionJul 2023 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type II DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- At the first visit, patients will be randomly assigned to control group or intervention group.
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Antenna Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Khon Kaen University
- Responsible party
- Sponsor
- Investigators
- Bertrand Graz, MD, MPH, Study director, Antenna Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05272839
- Sponsor's protocol ID
- DiabetesThai22
- Status last verified
- Feb 2022
- First submitted
- 17 Feb 2022
- Last updated
- 10 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 34899340
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Natural Hypoglycemic Foods and Blood Sugar Level: A Pilot Study
- ClinicalTrials.gov ID
- NCT05272839
- Acronym / sponsor ID
- DiabetesThai22
- Conditions
- Type II Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Antenna FoundationUniversity, hospital or other
- Collaborators
- Khon Kaen University
- Study start
- Apr 2022 (estimated)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 10 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- At the first visit, patients will be randomly assigned to control group or intervention group.
| Arm | Type | Receives |
|---|---|---|
| Hypoglycemic food group | Experimental | Dietary Supplement: Hypoglycemic food groupThe 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 comparator | Dietary Supplement: Control groupThe control group will receive only dietary advice and standard medication if any. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Type 2 diabetes patients with poorly controlled glycemia, i.e. at least one of the following measurements:
Key exclusion criteria (6 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypoglycemic food groupA 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). | Dietary supplement | Hypoglycemic food group |
| Control groupThe control group will receive only lifestyle and dietary recommendations. | Dietary supplement | Control group |
Primary outcome
Decrease of ≥ 0.5mmol/L in FPG
Time frame: 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
Time frame: 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
5 secondary outcomes
Mean change of FPG
Time frame: 12 weeks
Target glycemia
Time frame: 12 weeks
Weight
Time frame: 12 weeks
Mean change of HbA1c
Time frame: 12 weeks
Blood pressure
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
- Background: PubMed 34899340Willcox 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bertrand Graz, MD, MPH study director
Antenna Foundation
Questions about this trial
What is this clinical trial studying?
A study testing Hypoglycemic food group in people with Type II Diabetes, run by Antenna Foundation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Praew Kotruchin, Prof (+6643366869, kpraew@kku.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease of ≥ 0.5mmol/L in FPG (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05272839, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2022.