Effects of Calamansi on Blood Glucose | NCT04462016

Studies
Effects of Calamansi on Blood Glucose

NCT04462016

Sponsor

University Malaysia Sarawak

Status

Completed

Last Update Posted

Jul 8, 2020Actual

Enrollment

10Actual

Phase

Not Applicable

Conditions

Blood Glucose Response

Interventions

Calamansi
Glucose

Countries

Malaysia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2, 2018Actual

Primary Completion Date

May 6, 2018Actual

Completion Date

Aug 8, 2018Actual

First Submitted Date

Jul 1, 2020

First Submission Date that Met QC Criteria

Jul 3, 2020

First Posted Date

Jul 8, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 3, 2020

Last Update Posted Date

Jul 8, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Calamansi	Other	250 ml of a commercially sourced calamansi drink	Test drink

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

21 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Angela Siner, PhD	Universiti Malaysia Sarawak	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine and Health Sciences		Kuching	Sarawak	94300	Malaysia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32859257	Derived	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.

ID	Term
D006601	Hexoses
D009005	Monosaccharides
D000073893	Sugars
D002241	Carbohydrates