- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07587905
Effects of Calamansi on Blood Glucose and Insulin Levels
May 13, 2026 updated by: Piyapong Prasertsri, Burapha University
The Effects of Calamansi (Citrus x Macrocarpa Bunge) Supplementation on Blood Glucose and Insulin Levels in Healthy Volunteers
Fifty-four healthy sedentary male and female participants aged 18-30 years will be recruited for this study.
Participants will be randomly assigned to one of two groups: a control group receiving placebo MMC capsules (n = 27) or a calamansi capsule supplementation group (n = 27).
All participants will undergo health screening procedures, including medical history assessment, mental health questionnaire evaluation, and measurements of vital signs, height, body weight, and body composition.
Venous blood samples will subsequently be collected to determine blood glucose, insulin, creatinine, alanine aminotransferase (ALT), and malondialdehyde (MDA) levels.
These assessments will be performed at three time points: 1) before capsule supplementation (baseline), 2) following a single dose of capsule supplementation, and 3) after 12 weeks of supplementation.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
54
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 Contact
- Name: Piyapong Prasertsri, Ph.D.
- Phone Number: 6638103166
- Email: piyapong@buu.ac.th
Study Contact Backup
- Name: Kulwara Poolpol, Ph.D.
- Phone Number: 6638103147
- Email: kulwara@go.buu.ac.th
Study Locations
-
-
Burapha University
-
Mueang, Burapha University, Thailand, 20131
- Recruiting
- Piyapong Prasertsri
-
Contact:
- Piyapong Prasertsri, Ph.D.
- Phone Number: 6638103166
- Email: piyapong@buu.ac.th
-
Contact:
- Kulwara Poolpol, Ph.D.
- Phone Number: 6638103147
- Email: kulwara@go.buu.ac.th
-
-
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
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Healthy individuals who have not been diagnosed with diabetes or prediabetes, with a fasting blood glucose level (after 8 hours of fasting) of less than 100 mg/dL.
- Aged between 18-30 years, both male and female
- Body Mass Index (BMI) between 18.5 and 22.9 kg/m²
- No diseases affecting blood sugar levels, such as liver or pancreatic diseases
Exclusion Criteria:
- Pregnant or breastfeeding women
- Regular smokers
- Regular alcohol consumers
- Individuals with a history of allergies to citrus fruits or citrus-derived ingredients
- Individuals taking medications that affect glucose metabolism and fat distribution in the body, including steroids, protease inhibitors, and psychiatric medications. These refer to drugs that act on the central nervous system and may affect blood sugar levels or energy metabolism, such as antidepressants, antipsychotics, and mood stabilizers.
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: MMC powder capsule
Participants will be randomly assigned to an intervention arm.
During the short-term phase, participants in the control group will receive microcrystalline cellulose (MMC) capsules and will be instructed to consume 1,500 mg/day (three capsules).
During the long-term phase, participants will continue consuming MMC at a dose of 1,500 mg/day (three capsules), taken within 15-30 min after breakfast.
All supplementation will be administered at the participants' residences.
|
Each capsule contains MMC powder for 500 mg
|
|
Experimental: Calamansi powder capsule
Participants will be randomly assigned to an intervention arm.
During the short-term phase, participants in the calamansi group will receive calamansi powder capsules and will be instructed to consume 1,500 mg/day (three capsules).
During the long-term phase, participants will continue consuming calamansi powder capsules at a dose of 1,500 mg/day (three capsules), taken within 15-30 min after breakfast.
All supplementation will be administered at the participants' residences.
|
Each capsule contains calamansi powder for 500 mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Concentrations of blood glucose
Time Frame: At 0 minute before consumption, at 30, 60, 90, 120 minutes after consumption, and at days 91 after consumption
|
Concentrations of blood glucose were measured before and after MMC capsules or calamansi capsule consumption at 500 mg in mg/dL unit
|
At 0 minute before consumption, at 30, 60, 90, 120 minutes after consumption, and at days 91 after consumption
|
|
Concentrations of blood insulin
Time Frame: At 0 minute before consumption, at 120 minute after consumption, and at days 91 after consumption
|
Concentrations of blood insulin were measured before and after MMC capsules or calamansi capsule consumption at 500 mg in uU/mL (microunit/milliliter) unit
|
At 0 minute before consumption, at 120 minute after consumption, and at days 91 after consumption
|
|
Concentrations of blood malondialdehyde
Time Frame: At 0 minute before consumption, at 120 minute after consumption, and at days 91 after consumption
|
Concentrations of blood malondialdehyde were measured before and after MMC capsules or calamansi capsule consumption at 500 mg in uM (micromolar) unit
|
At 0 minute before consumption, at 120 minute after consumption, and at days 91 after consumption
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Levels of heart rate variability
Time Frame: At 0-10 minutes before consumption, at 110-120 minutes after consumption, and at days 91 after consumption for 10 minutes
|
Heart rate variability were measured before and after MMC capsules or calamansi capsule consumption at 500 mg in ms (milliseconds) and ms2 (millisecond squared) unit
|
At 0-10 minutes before consumption, at 110-120 minutes after consumption, and at days 91 after consumption for 10 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Piyapong Prasertsri, Ph.D., Faculty of Allied Health Sciences, Burapha University
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)
May 1, 2026
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
January 31, 2027
Study Registration Dates
First Submitted
May 8, 2026
First Submitted That Met QC Criteria
May 8, 2026
First Posted (Actual)
May 14, 2026
Study Record Updates
Last Update Posted (Actual)
May 15, 2026
Last Update Submitted That Met QC Criteria
May 13, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- IRB1-033/2569
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
There is no plan to make individual participant data available to other researchers.
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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