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Recruiting NCT07587905

Effects of Calamansi on Blood Glucose and Insulin Levels

No phase Interventional Calamansi Powder Capsule Supplementation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MMC powder capsule, Calamansi powder capsule.
Who it may be relevant to
Registry conditions: Calamansi Powder Capsule Supplementation. Basic parameters: 18 years — 30 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Thailand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Effects of Calamansi (Citrus x Macrocarpa Bunge) Supplementation on Blood Glucose and Insulin Levels in Healthy Volunteers

Overview

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.

Interventions

  • Other MMC powder capsule
    Each capsule contains MMC powder for 500 mg
  • Dietary supplement Calamansi powder capsule
    Each capsule contains calamansi powder for 500 mg

Primary outcome measures

  • 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 insulin [Time frame: 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]
Secondary outcome measures (1)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Prevention

Study locations

Thailand · 1 center
  • Piyapong Prasertsri — Mueang

Identifiers

NCT: NCT07587905 · IRB1-033/2569

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗