The Effect of Konjac Grain in the Post-prandial Glycaemic Response of Healthy Subjects

NCT ID: NCT05850949

Last Updated: 2023-05-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-10
• Study Completion Date: 2023-05-31

Brief Summary

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

1. 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.

2. 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Konjac-Grain

Without supplementation, followed by Supplementation with Konjac grain from PT. AMBICO

Group Type: EXPERIMENTAL

Konjac Grain

Intervention Type: DIETARY_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

Interventions

Konjac Grain

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1. Healthy male or female, aged 18-50 years

2. Not currently taking any medication

3. 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.

4. Agree to be included as a research subject (by signing an informed consent)

Exclusion Criteria

1. Was experiencing an acute infectious disease at the time of the study

2. Lack of sleep or heavy physical activity during the study

3. Subjects experienced pregnancy during the study

4. Subjects withdrew at any time during the research

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universitas Katolik Widya Mandala Surabaya

OTHER

Sponsor Role: lead

Responsible Party

Hendy Wijaya

Head of Clinical Pharmacology research laboratories

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universitas Katolik Widya Mandala Surabaya

Surabaya, East Java, Indonesia

Countries

Indonesia

Other Identifiers

0015/WM12/KEPK/DSN/T/2023

Identifier Type: -

Identifier Source: org_study_id