Effects of Calamansi on Blood Glucose and Insulin Levels

Официальное название

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

Обзор

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.

Вмешательства

• Другое MMC powder capsule
  Each capsule contains MMC powder for 500 mg
• Пищевая добавка Calamansi powder capsule
  Each capsule contains calamansi powder for 500 mg

Первичные конечные точки

• Concentrations of blood glucose [Срок оценки: At 0 minute before consumption, at 30, 60, 90, 120 minutes after consumption, and at days 91 after consumption]
• Concentrations of blood insulin [Срок оценки: At 0 minute before consumption, at 120 minute after consumption, and at days 91 after consumption]
• Concentrations of blood malondialdehyde [Срок оценки: At 0 minute before consumption, at 120 minute after consumption, and at days 91 after consumption]

Вторичные конечные точки (1)

• Levels of heart rate variability [Срок оценки: At 0-10 minutes before consumption, at 110-120 minutes after consumption, and at days 91 after consumption for 10 minutes]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Профилактика

Центры проведения

Таиланд · 1 центр

• Piyapong Prasertsri — Mueang

Идентификаторы

NCT: NCT07587905 · IRB1-033/2569

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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