Blood Glucose ResponseNCT04462016
Effects of Calamansi on Blood Glucose
A study testing Calamansi and Glucose in people with Blood Glucose Response, run by University Malaysia Sarawak at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 21 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Blood Glucose Response
- What is being tested?
- Calamansi and Glucose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteMalaysia
- Study dates
- 2 Feb 2018to 8 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 21 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- pre-existing conditions such as HIV, hepatitis, inflammatory bowel diseases, diabetes mellitus, kidney disease, blood disorders (such as thalassaemia)
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Faculty of Medicine and Health Sciences
Kuching, Sarawak, 94300
About this study
Official title: 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.
- Conditions
- Blood Glucose Response
- Being tested
- Calamansi, Glucose
- Keywords
- calamansi, glycaemic index, post-prandial blood glucose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CalamansiOther
250 ml of a commercially sourced calamansi drink
GlucoseOther
75 g of glucose dissolved in 250 ml of drinking water
| Study group | Role | What they receive |
|---|---|---|
| Reference drink | Active comparator | Healthy volunteers' blood glucose response to reference drink (glucose) Receives: Other: Glucose |
| Test drink | Experimental | Healthy volunteers' blood glucose response to test drink (calamansi) Receives: Other: Calamansi |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline blood glucose levels
Capillary blood glucose using glucometer
Measured: 30, 60, 90, 120 min after drinking
Secondary outcomes (1)
Change from baseline urinary glucose levels
Dipstick test
Measured: 30, 60, 90, 120 min after drinking
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start2 Feb 2018
- Primary completion6 May 2018
- Study completion8 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood Glucose ResponseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Malaysia Sarawak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angela Siner, PhD, Principal investigator, Universiti Malaysia Sarawak
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04462016
- Sponsor's protocol ID
- MDP20505_2017/2018_MS0001
- Status last verified
- Jul 2020
- First submitted
- 1 Jul 2020
- Last updated
- 8 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 32859257
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Glucose Response to a Calamansi Drink in Healthy Adults
- ClinicalTrials.gov ID
- NCT04462016
- Acronym / sponsor ID
- MDP20505_2017/2018_MS0001
- Conditions
- Blood Glucose Response
- Keywords
- calamansi, glycaemic index, post-prandial blood glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Malaysia SarawakUniversity, hospital or other
- Study start
- 2 Feb 2018 (actual)
- Primary completion
- 6 May 2018 (actual)
- Study completion
- 8 Aug 2018 (actual)
- First posted
- 8 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reference drink | Active comparator | Other: GlucoseHealthy volunteers' blood glucose response to reference drink (glucose) |
| Test drink | Experimental | Other: CalamansiHealthy volunteers' blood glucose response to test drink (calamansi) |
Who may qualify
- Ages
- 18 to 21 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (1 listed)
- pre-existing conditions such as HIV, hepatitis, inflammatory bowel diseases, diabetes mellitus, kidney disease, blood disorders (such as thalassaemia)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calamansi250 ml of a commercially sourced calamansi drink | Other | Test drink |
| Glucose75 g of glucose dissolved in 250 ml of drinking water | Other | Reference drink |
Primary outcome
Change from baseline blood glucose levels
Time frame: 30, 60, 90, 120 min after drinking
Capillary blood glucose using glucometer
1 secondary outcome
Change from baseline urinary glucose levels
Time frame: 30, 60, 90, 120 min after drinking
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2020.
- Derived from this study: PubMed 32859257Siner 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.
- Individual participant dataSharing planned: Yes
Related trials for Blood Glucose Response
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
Not yet recruitingObservational study
Maternal Glucose, Cortisol, and Neonatal Outcomes With and Without GDM
Gestational Diabetes Mellitus in Pregnancy, Diet- Controlled
Recruiting
Effects of Pre-Run Nutritional Supplements During a Fixed-Pace 5 km Treadmill Run
Exercise Physiology, Nutritional Supplementation
Not yet recruiting
Effect of Proso Millet-Based Bread on Postprandial Glycemic Response in Adults With Type 2 Diabetes
Tip 2 Diabetes Mellitus
Recruiting
Relaxing Virtual Reality Use and Blood Glucose Response to Food (ReViR) Study
Post Prandial Blood Glucose, Feasibility Pilot Study
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela Siner, PhD principal investigator
Universiti Malaysia Sarawak
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calamansi and Glucose in people with Blood Glucose Response, run by University Malaysia Sarawak at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline blood glucose levels (time frame: 30, 60, 90, 120 min after drinking). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04462016, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2020.