The Effects of Calamansi (Citrus x Macrocarpa Bunge) Supplementation on Blood Glucose and Insulin Levels in Healthy Volunteers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Burapha University
- Enrollment
- 54
- Locations
- 1
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 30 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
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.
Intervention: MMC powder capsule (Other)
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.
Intervention: Calamansi powder capsule (Dietary Supplement)
Investigators
Piyapong Prasertsri
Associate Professor Dr.
Burapha University