- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04313543
Glycemic Index of Longan Syrup in Healthy Volunteers
March 17, 2020 updated by: Pornanong Aramwit, Pharm.D., Ph.D, Chulalongkorn University
Determination of Glycemic Index of Longan Syrup in Healthy Volunteers
Volunteers take 50 g of glucose in 250 ml of water in 5 minutes.Then, they are tested blood glucose levels (taken from the fingertips) at 15, 30 ,45, 60, 90, and 120 minutes.
There is 3 days for wash out period.
These tests will be repeated for 3 times for baseline glucose calculation.
After that, volunteers take 50 g of longan syrup in 250 ml of water in 5 minutes.Then, they are tested blood glucose levels (taken from the fingertips) at 15, 30 ,45, 60, 90, and 120 minutes.
Glycemic index of longan syrup is calculated from area under the curved of blood glucose after longan syrup taking divided to mean of area under the curved of blood glucose after glucose taking.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Ages 18-60 years
- Never diagnosis as diabetes mellitus of thyroid dysfunction
- Fasting plasma glucose less than 100 mg/dl
- Body mass index 18.5-24.9 kg/m2
- Be willing to be subjects in this study
Exclusion Criteria:
- Know longan allergy or have history of adverse events from longan
- Take medicines, herbs, or food supplements including thiazide diuretics, beta-blockers ,and estrogen that have an effect on blood sugar level in 1 month before this study starting
- Severe comorbidity or uncontrolled diseases
- Pregnancy and lactation
- Participated in other studies
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Glucose and Longan syrup
Volunteers take 50 g of glucose in 250 ml of water in 5 minutes.Then, they are tested blood glucose levels (taken from the fingertips) at 15, 30 ,45, 60, 90, and 120 minutes.
There is 3 days for wash out period.
These tests will be repeated for 3 times for baseline glucose calculation.
After that, volunteers take 50 g of longan syrup in 250 ml of water in 5 minutes.Then, they are tested blood glucose levels (taken from the fingertips) at 15, 30 ,45, 60, 90, and 120 minutes.
Glycemic index of longan syrup is calculated from area under the curved of blood glucose after longan syrup taking divided to mean of area under the curved of blood glucose after glucose taking
|
Volunteers take 50 g of glucose in 250 ml of water in 5 minutes.
Then, they take 50g of longan syrup in 250 ml of water in 5 minutes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood glucose
Time Frame: Change from glucose baseline in 120 minutes
|
They are tested blood glucose levels (taken from the fingertips) at 15, 30 ,45, 60, 90, and 120 minutes.
There is 3 days for wash out period.
These tests will be repeated for 3 times for baseline glucose calculation.
|
Change from glucose baseline in 120 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adverse events
Time Frame: 12 days
|
Number of participants with skin, respiratory, and gastrointestinal side effects
|
12 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
March 24, 2020
Primary Completion (ANTICIPATED)
February 28, 2021
Study Completion (ANTICIPATED)
March 3, 2021
Study Registration Dates
First Submitted
March 13, 2020
First Submitted That Met QC Criteria
March 17, 2020
First Posted (ACTUAL)
March 18, 2020
Study Record Updates
Last Update Posted (ACTUAL)
March 18, 2020
Last Update Submitted That Met QC Criteria
March 17, 2020
Last Verified
March 1, 2020
More Information
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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