NCT04462016

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 2, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 6, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2018

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

July 1, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 8, 2020

Completed
Last Updated

July 8, 2020

Status Verified

July 1, 2020

Enrollment Period

3 months

First QC Date

July 1, 2020

Last Update Submit

July 3, 2020

Conditions

Keywords

calamansiglycaemic indexpost-prandial blood glucose

Outcome Measures

Primary Outcomes (1)

  • Change from baseline blood glucose levels

    Capillary blood glucose using glucometer

    30, 60, 90, 120 min after drinking

Secondary Outcomes (1)

  • Change from baseline urinary glucose levels

    30, 60, 90, 120 min after drinking

Study Arms (2)

Reference drink

ACTIVE COMPARATOR

Healthy volunteers' blood glucose response to reference drink (glucose)

Other: Glucose

Test drink

EXPERIMENTAL

Healthy volunteers' blood glucose response to test drink (calamansi)

Other: Calamansi

Interventions

250 ml of a commercially sourced calamansi drink

Test drink
GlucoseOTHER

75 g of glucose dissolved in 250 ml of drinking water

Reference drink

Eligibility Criteria

Age18 Years - 21 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine and Health Sciences

Kuching, Sarawak, 94300, Malaysia

Location

Related Publications (1)

  • Siner A, Sevanesan MS, Ambomai T, Abd Wahab Z, Lasem L. Blood glucose response to a calamansi drink in healthy adults: a non-randomised study. BMC Res Notes. 2020 Aug 28;13(1):404. doi: 10.1186/s13104-020-05250-8.

MeSH Terms

Interventions

Glucose

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydrates

Study Officials

  • Angela Siner, PhD

    Universiti Malaysia Sarawak

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2020

First Posted

July 8, 2020

Study Start

February 2, 2018

Primary Completion

May 6, 2018

Study Completion

August 8, 2018

Last Updated

July 8, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL
Time Frame
This will be made available starting 6 months from the date of publication; for the next 5 years.
Access Criteria
Through reasonable request to the corresponding author.

Locations