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

determine the effect of giving the Konjac-Grain formula as a mixture of white rice in suppressing post-prandial glucose absorption.

Study Overview

• Status: Not yet recruiting
• Conditions: Diet, Healthy
• Intervention / Treatment: Dietary supplement: Konjac Grain

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • Jawa Timur
    • Surabaya, Jawa Timur, Indonesia, 60112
      • Universitas Katolik Widya Mandala Surabaya

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Konjac-Grain; Without supplementation, followed by Supplementation with Konjac grain from PT. AMBICO

Dietary supplement: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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	2 hours after meals.

Collaborators and Investigators

• Sponsor: Universitas Katolik Widya Mandala Surabaya

Study record dates

Study Major Dates

• Study Start (Anticipated): May 10, 2023
• Primary Completion (Anticipated): May 16, 2023
• Study Completion (Anticipated): May 31, 2023

Study Registration Dates

• First Submitted: March 29, 2023
• First Submitted That Met QC Criteria: May 8, 2023
• First Posted (Actual): May 9, 2023

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 0015/WM12/KEPK/DSN/T/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Share after publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No