Clinical trial NCT05850949: The Effect of Konjac Grain in the Post-prandial Glycaemic Response of Healthy Subjects
Official title: The Effect of Konjac Grain in the Post-prandial Glycaemic Response of Healthy Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diet, Healthy
Lead sponsor: Universitas Katolik Widya Mandala Surabaya
Sponsor class: OTHER
First posted: 2023-05-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Repeated single arm
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change Post prandial blood glucose
timeFrame: 2 hours after meals.
measure: Change Post prandial blood HbA1c
timeFrame: 2 hours after meals.
Secondary outcomes:
Other outcomes:
Locations:
city: Surabaya
country: Indonesia
facility: Universitas Katolik Widya Mandala Surabaya
state: Jawa Timur
Study officials:
References: