Effect of Cow's Milk Kefir on Short Chain Fatty Acid (SCFA), Haemoglobin, and Ferritin Levels of Anemic Adolescent Girls

Официальное название

Effect of Cow's Milk Kefir on Short Chain Fatty Acid (SCFA), Haemoglobin, and Ferritin Levels of Anemic Adolescent Girls in Yogyakarta, Indonesia

Обзор

Introduction: The prevalence of anemia among adolescent girls in Indonesia is still quite high. According to the Indonesian Health Survey (IHS) in 2023, it was 18% and is still a national problem. Long-term supplementation of blood supplement tablets (TTD) as an effort made by the government to prevent/overcome anemia has caused side effects, namely dysbiosis by pathogenic bacteria. Giving cow's milk kefir containing various probiotics can overcome the side effects of supplementation, and its metabolites accelerate iron absorption so that iron status in the blood increases and ultimately restores anemia in adolescent girls. Method: It's research is an experimental study, with a Randomized Controlled Trial (RCT) design, pre-posttest design, involving research subjects of adolescent girls (15-18 years) with mild and moderate anemia, at SMKN 1, 2, and 3 Kasihan, Bantul Regency, Yogyakarta as many as 80 students. Subjects were divided into 2 groups, namely group 1 (treatment group), which was given 120 ml of cow's milk kefir every day and TTD 1 grain/week, and group 2 (control group), which was given 120 ml of cow's milk every day and TTD 1 grain/week. The duration of administration was 2 months. The study outcomes were Short Chain Fatty Acid (SCFA) levels in feces by Gas Chromatography-Mass Spectrometry (GC-MS) method, hemoglobin by Hematology Analyser method, and serum ferritin by Ferritin ELISA measured at the beginning and end of the study. Statistical analysis included univariate, bivariate, and multivariate analysis. Clinical analysis was also conducted to estimate the effect size of the treatment

Подробное описание

This protocol represents the only doctoral research dissertation proposal I will undertake as part of my dissertation, which does not exist.

Вмешательства

• Комбинированный продукт cow's milk kefir
  group given cow's milk kefir and blood supplement tablets (TTD)
• Комбинированный продукт pasteurized cow's milk
  group given pasteurized cow's milk and blood supplement tablets (TTD)

Первичные конечные точки

• Short Chain Fatty Acid [Срок оценки: 2 months after intervention]
• hemoglobin [Срок оценки: 2 months after intervention]
• Ferritin [Срок оценки: 2 months after intervention]

Вторичные конечные точки (4)

• Nutrient intake [Срок оценки: 2 months after intervention]
• Nutritional status of adolescent girls (body mass index / age) [Срок оценки: 2 months after intervention]
• Menstrual cycle and duration of adolescent girls [Срок оценки: 2 months after intervention]
• Diarrhea [Срок оценки: 2 months after intervention]

Критерии участия

Критерии включения

• Adolescent girls aged 15-18 years
• Have a mild and moderate degree of anemia (Hb 8-11.9 g/dl)
• Have a normal menstrual cycle and duration

Критерии исключения

• Suffering from thalassemia, hemosiderosis, blood cancer, and malaria, based on the doctor's diagnosis in the last 3 months
• Taking supplements other than TTD
• Taking antibiotics in the last 3 months
• Suffering from lactose intolerance through interviews

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

Лечение

Центры проведения

Индонезия · 1 центр

• Gadjah Mada University — Yogyakarta

Идентификаторы

NCT: NCT06957717 · GadjahMada

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗