Effects of Calamansi on Blood Glucose and Insulin Levels

NCT07587905 | Recruiting DMC

• 1 other identifier: IRB1-033/2569
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Calamansi Powder Capsule Supplementation

Outcome Measures

Primary Outcomes (3)

• Concentrations of blood glucose

  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

  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

  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 Outcomes (1)

• Levels of heart rate variability

  At 0-10 minutes before consumption, at 110-120 minutes after consumption, and at days 91 after consumption for 10 minutes

Study Arms (2)

MMC powder capsule

PLACEBO COMPARATOR

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.

Other: MMC powder capsule

Calamansi powder capsule

EXPERIMENTAL

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.

Dietary Supplement: Calamansi powder capsule

Interventions

MMC powder capsule OTHER

Each capsule contains MMC powder for 500 mg

MMC powder capsule

Calamansi powder capsule DIETARY_SUPPLEMENT

Each capsule contains calamansi powder for 500 mg

Calamansi powder capsule

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Burapha University: lead

Study Sites (1)

Piyapong Prasertsri

Mueang, Burapha University, 20131, Thailand

RECRUITING

Study Officials

• Piyapong Prasertsri, Ph.D.

  Faculty of Allied Health Sciences, Burapha University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Piyapong Prasertsri, Ph.D.

CONTACT

6638103166; piyapong@buu.ac.th

Kulwara Poolpol, Ph.D.

CONTACT

6638103147; kulwara@go.buu.ac.th

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Dr.

Model Details: Participants will be randomly divided into 2 groups consisting of placebo group (n = 27) or a treatment group (n = 27).

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: May 14, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)