Diet, HealthyKonjacNCT05850949
The Effect of Konjac Grain in the Post-prandial Glycaemic Response of Healthy Subjects
A study testing Konjac Grain in people with Diet, Healthy, run by Universitas Katolik Widya Mandala Surabaya at 1 site in Indonesia.
Trial summary
determine the effect of giving the Konjac-Grain formula as a mixture of white rice in suppressing post-prandial glucose absorption. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet, Healthy
- What is being tested?
- Konjac Grain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIndonesia
- Study dates
- 10 May 2023to 31 May 2023
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female, aged 18-50 years
- Not currently taking any medication
- Do not have a history of metabolic diseases such as hypertension, prediabetes, metabolic syndrome, non-alcoholic fatty liver disease (NAFLD) previously from the results of doctor and laboratory examinations.
- Agree to be included as a research subject (by signing an informed consent)
Who cannot join
- Was experiencing an acute infectious disease at the time of the study
- Lack of sleep or heavy physical activity during the study
- Subjects experienced pregnancy during the study
- Subjects withdrew at any time during the research
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Universitas Katolik Widya Mandala Surabaya
Surabaya, East Java, 60112
About this study
determine the effect of giving the Konjac-Grain formula as a mixture of white rice in suppressing post-prandial glucose absorption.
Read the detailed description
To determine the effect of giving the Konjac-Grain formula as a mixture of white rice in suppressing post-prandial glucose absorption.
Benefits of research
- Scientific benefits Add insight into basic science in the field of metabolic physiology and as a scientific reference in the field of nutrition regarding the benefits of konjac grain in helping to improve blood glucose levels.
- Practical benefits Providing information, education and knowledge to the public that dietary fiber in the form of konyaku grains is a functional food fiber that has the potential to be useful in improving blood glucose levels.
Length of Research Time:
This research will be carried out for approximately 6 weeks and the treatment will be carried out on the first day of each week. The new treatment was repeated the following week.
Notice of Research Results The blood glucose level examination results will be recorded and given to the test subject on the same day or at the next examination.
Research procedure On the first day of every week the patient will be asked to fast at night for 10-12 hours, then the next day, the subjects are given a ready-to-eat meal treatment with rice mixed with the Konjac-Grain grain formula. After eating, blood glucose levels were measured every 30 minutes for 2 hours. This procedure is repeated weekly with different rice: the Konjac-Grain ratio.
The test subject is asked to sign and write down the date on the consent confirmation sheet to participate as a respondent in this study. The test subject's participation in this research is voluntary. The test subject has the full right to withdraw or cancel participation at anytime. All information on the results of your blood tests is confidential.
The test subject's blood will be collected. This procedure will cause pain in the injection area and blood collection. So far there has never been a report that giving the Konjac-Grain grains or other dietary fiber can cause significant health side effects.
- Conditions
- Diet, Healthy
- Being tested
- Konjac Grain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Konjac GrainDietary supplement
Without supplementation, followed by Supplementation with Dietary Fibre the Konjac-Grain week 1, repeated until week 6, blood collected with a fine needle 10ml citrate-Tube Glucose was measured with disposable 'test-strip', which is then inserted into an electronic blood glucose meter (device: Accu-Check Instant S Glucose from Roche) . Normal value:70 to 99 mg/dL (3.9 to 5.5 mmol/L). Further HbA1c (glycated Hemoglobin A1c) concentration was checked with disposable 'test-strip', which is then inserted into an electronic HbA1c meter (device: Accu-Check Instant S HbA1c from Roche). Unit value fir HbA1c = mg/dl
| Study group | Role | What they receive |
|---|---|---|
| Konjac-Grain | Experimental | Without supplementation, followed by Supplementation with Konjac grain from PT. AMBICO Receives: Dietary Supplement: Konjac Grain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change Post prandial blood glucose
Without supplementation, followed by Supplementation with Dietary Fibre the Konjac-Grain week 1, repeated until week 6, blood collected 2 hours after meals with a 3" fine needle 10ml Citrat-Tube
blood Glucose (mg/dl or mmol/L) one drop (50microliter) of blood from citrat-Tube was transferred to the Glucose test strip. Glucose was measured with disposable 'test-strip', which is then inserted into an electronic blood glucose meter (device: Accu-Check Instant S Glucose from Roche) .
Normal value:70 to 99 mg/dL (3.9 to 5.5 mmol/L).
Measured: 2 hours after meals.
Change Post prandial blood HbA1c
Without supplementation, followed by Supplementation with Dietary Fibre the Konjac-Grain week 1, repeated until week 6, blood collected 2 hours after meals with a 3" fine needle 10ml Citrat-Tube
blood HbA1c (mg/dl) one drop (50microliter) of blood from citrat-Tube was transferred to the HbA1c test strip. HbA1c was measured with disposable 'test-strip', which is then inserted into an electronic blood glucose meter (device: Accu-Check Instant S HbA1c from Roche) .
Normal value:80-180 mg/dL
Measured: 2 hours after meals.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start10 May 2023 (estimated)
- Primary completion16 May 2023 (estimated)
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet, HealthyStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Repeated single arm
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Katolik Widya Mandala Surabaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hendy Wijaya, Universitas Katolik Widya Mandala Surabaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05850949
- Sponsor's protocol ID
- 0015/WM12/KEPK/DSN/T/2023
- Acronym
- Konjac
- Status last verified
- Apr 2023
- First submitted
- 29 Mar 2023
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Share after publication
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Konjac Grain in the Post-prandial Glycaemic Response of Healthy Subjects
- ClinicalTrials.gov ID
- NCT05850949
- Acronym / sponsor ID
- Konjac / 0015/WM12/KEPK/DSN/T/2023
- Conditions
- Diet, Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universitas Katolik Widya Mandala SurabayaUniversity, hospital or other
- Study start
- 10 May 2023 (estimated)
- Primary completion
- 16 May 2023 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 9 May 2023 (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.
determine the effect of giving the Konjac-Grain formula as a mixture of white rice in suppressing post-prandial glucose absorption.
Detailed description
To determine the effect of giving the Konjac-Grain formula as a mixture of white rice in suppressing post-prandial glucose absorption.
Benefits of research
- Scientific benefits Add insight into basic science in the field of metabolic physiology and as a scientific reference in the field of nutrition regarding the benefits of konjac grain in helping to improve blood glucose levels.
- Practical benefits Providing information, education and knowledge to the public that dietary fiber in the form of konyaku grains is a functional food fiber that has the potential to be useful in improving blood glucose levels.
Length of Research Time:
This research will be carried out for approximately 6 weeks and the treatment will be carried out on the first day of each week. The new treatment was repeated the following week.
Notice of Research Results The blood glucose level examination results will be recorded and given to the test subject on the same day or at the next examination.
Research procedure On the first day of every week the patient will be asked to fast at night for 10-12 hours, then the next day, the subjects are given a ready-to-eat meal treatment with rice mixed with the Konjac-Grain grain formula. After eating, blood glucose levels were measured every 30 minutes for 2 hours. This procedure is repeated weekly with different rice: the Konjac-Grain ratio.
The test subject is asked to sign and write down the date on the consent confirmation sheet to participate as a respondent in this study. The test subject's participation in this research is voluntary. The test subject has the full right to withdraw or cancel participation at anytime. All information on the results of your blood tests is confidential.
The test subject's blood will be collected. This procedure will cause pain in the injection area and blood collection. So far there has never been a report that giving the Konjac-Grain grains or other dietary fiber can cause significant health side effects.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Repeated single arm
| Arm | Type | Receives |
|---|---|---|
| Konjac-Grain | Experimental | Dietary Supplement: Konjac GrainWithout supplementation, followed by Supplementation with Konjac grain from PT. AMBICO |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male or female, aged 18-50 years
- Not currently taking any medication
- Do not have a history of metabolic diseases such as hypertension, prediabetes, metabolic syndrome, non-alcoholic fatty liver disease (NAFLD) previously from the results of doctor and laboratory examinations.
- Agree to be included as a research subject (by signing an informed consent)
Key exclusion criteria (4 listed)
- Was experiencing an acute infectious disease at the time of the study
- Lack of sleep or heavy physical activity during the study
- Subjects experienced pregnancy during the study
- Subjects withdrew at any time during the research
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 |
|---|---|---|
| Konjac GrainWithout supplementation, followed by Supplementation with Dietary Fibre the Konjac-Grain week 1, repeated until week 6, blood collected with a fine needle 10ml citrate-Tube Glucose was measured with disposable 'test-strip', which is then inserted into an electronic blood glucose meter (device: Accu-Check Instant S Glucose from Roche) . Normal value:70 to 99 mg/dL (3.9 to 5.5 mmol/L). Further HbA1c (glycated Hemoglobin A1c) concentration was checked with disposable 'test-strip', which is then inserted into an electronic HbA1c meter (device: Accu-Check Instant S HbA1c from Roche). Unit value fir HbA1c = mg/dl | Dietary supplement | Konjac-Grain |
Primary outcome
Change Post prandial blood glucose
Time frame: 2 hours after meals.
Without supplementation, followed by Supplementation with Dietary Fibre the Konjac-Grain week 1, repeated until week 6, blood collected 2 hours after meals with a 3" fine needle 10ml Citrat-Tube blood Glucose (mg/dl or mmol/L) one drop (50microliter) of blood from citrat-Tube was transferred to the Glucose test strip. Glucose was measured with disposable 'test-strip', which is then inserted into an electronic blood glucose meter (device: Accu-Check Instant S Glucose from Roche) . Normal value:70 to 99 mg/dL (3.9 to 5.5 mmol/L).
Change Post prandial blood HbA1c
Time frame: 2 hours after meals.
Without supplementation, followed by Supplementation with Dietary Fibre the Konjac-Grain week 1, repeated until week 6, blood collected 2 hours after meals with a 3" fine needle 10ml Citrat-Tube blood HbA1c (mg/dl) one drop (50microliter) of blood from citrat-Tube was transferred to the HbA1c test strip. HbA1c was measured with disposable 'test-strip', which is then inserted into an electronic blood glucose meter (device: Accu-Check Instant S HbA1c from Roche) . Normal value:80-180 mg/dL
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Individual participant dataSharing planned: No. Share after publication
Related trials for Diet, Healthy
Not yet recruiting
Testing a Smartphone App to Support a Mediterranean Diet and Strength Exercise
Treatment Adherence and Compliance, Resistance Exercise
Not yet recruiting
Effects of Ad Libitum Ultra-Processed Diet on Brain Dopamine in Humans
Healthy Volunteers
Recruiting
Nutrition Outcomes Using a Randomized Intervention Via Smartphone on Dietary Habits
Healthy Adult Participants, Mindful Eating Intervention
Not yet recruiting
Web-Based Sustainable Food Literacy Program for University Students
Food Literacy, Healthy Eating
Recruiting
Environmental Harm Menu Labels and Overall Dietary Quality
Food Choices
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Konjac Grain in people with Diet, Healthy, run by Universitas Katolik Widya Mandala Surabaya at 1 site in Indonesia.
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 4 inclusion and 4 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 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change Post prandial blood glucose (time frame: 2 hours after meals.). 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?
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 9 May 2023.