Effects of Calamansi on Blood Glucose and Insulin Levels
The Effects of Calamansi (Citrus x Macrocarpa Bunge) Supplementation on Blood Glucose and Insulin Levels in Healthy Volunteers
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
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
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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
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / 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
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
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
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At 0-10 minutes before consumption, at 110-120 minutes after consumption, and at days 91 after consumption for 10 minutes
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Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Piyapong Prasertsri, Ph.D., Faculty of Allied Health Sciences, Burapha University
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- IRB1-033/2569
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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