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

NCT05850949 | Unknown DMC

• 1 other identifier: 0015/WM12/KEPK/DSN/T/2023
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diet, Healthy

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (1)

Konjac-Grain

EXPERIMENTAL

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

Dietary Supplement: Konjac Grain

Interventions

Konjac Grain 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

Konjac-Grain

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitas Katolik Widya Mandala Surabaya: lead

Study Sites (1)

Universitas Katolik Widya Mandala Surabaya

Surabaya, East Java, 60112, Indonesia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Clinical Pharmacology research laboratories

Model Details: Repeated single arm

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: May 9, 2023
• Study Start: May 10, 2023
• Primary Completion: May 16, 2023
• Study Completion: May 31, 2023
• Last Updated: May 9, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)