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临床试验/NCT05850949
NCT05850949尚未招募不适用

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

Universitas Katolik Widya Mandala Surabaya2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年5月10日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
20
试验地点
2
主要终点
Change Post prandial blood HbA1c

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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

结局指标

主要结局

Change Post prandial blood HbA1c

时间窗: 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

Change Post prandial blood glucose

时间窗: 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).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hendy Wijaya

Head of Clinical Pharmacology research laboratories

Universitas Katolik Widya Mandala Surabaya

研究点 (2)

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