Effects of Calamansi on Blood Glucose

July 3, 2020 updated by: University Malaysia Sarawak

Blood Glucose Response to a Calamansi Drink in Healthy Adults

It is important to bring the blood glucose levels of those with type 2 diabetes mellitus (T2DM) back to normal levels as this can stop the condition from worsening and prevent other conditions that are related to T2DM from developing. One way to maintain healthy blood glucose level is the use of the glycaemic index (GI), which ranks food according to how the body responds to its carbohydrate content. Low GI foods corresponds to low increase in blood glucose levels. Calamansi is a citrus that is believed not to induce an increase in blood glucose levels. Since beverages from calamansi are available and diabetes is a health concern in the community, it is important to investigate the effect of consuming this drink. Finger prick blood were tested in order to obtain the blood glucose levels for calculating the GI for the calamansi drink.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Sarawak
      • Kuching, Sarawak, Malaysia, 94300
        • Faculty of Medicine and Health Sciences

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

14 years to 17 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • non-smoker
  • BMI between 18.5 and 24.99 kg/m2
  • waist circumference less than 102 cm
  • random blood glucose less than 7.8 mmol/L
  • negative urine dipstick result
  • not on any medications
  • no family history of inherited diseases
  • no heart conditions (angina, arrhythmia or heart failure)
  • no history of acute medical or surgical event within the past 6 months.

Exclusion Criteria:

  • pre-existing conditions such as HIV, hepatitis, inflammatory bowel diseases, diabetes mellitus, kidney disease, blood disorders (such as thalassaemia)

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: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Reference drink
Healthy volunteers' blood glucose response to reference drink (glucose)
Other: Glucose
75 g of glucose dissolved in 250 ml of drinking water
Experimental: Test drink
Healthy volunteers' blood glucose response to test drink (calamansi)
Other: Calamansi
250 ml of a commercially sourced calamansi drink

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline blood glucose levels
Time Frame: 30, 60, 90, 120 min after drinking
Capillary blood glucose using glucometer
30, 60, 90, 120 min after drinking

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline urinary glucose levels
Time Frame: 30, 60, 90, 120 min after drinking
Dipstick test
30, 60, 90, 120 min after drinking

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Malaysia Sarawak

Investigators

  • Principal Investigator: Angela Siner, PhD, Universiti Malaysia Sarawak

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

February 2, 2018

Primary Completion (Actual)

May 6, 2018

Study Completion (Actual)

August 8, 2018

Study Registration Dates

First Submitted

July 1, 2020

First Submitted That Met QC Criteria

July 3, 2020

First Posted (Actual)

July 8, 2020

Study Record Updates

Last Update Posted (Actual)

July 8, 2020

Last Update Submitted That Met QC Criteria

July 3, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MDP20505_2017/2018_MS0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Time Frame

This will be made available starting 6 months from the date of publication; for the next 5 years.

IPD Sharing Access Criteria

Through reasonable request to the corresponding author.

IPD Sharing Supporting Information Type

  • Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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