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

NCT06957717 | Not Yet Recruiting DMC

• 1 other identifier: GadjahMada
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Iron Deficiency Anemia

Keywords

Kefir; Short Chain Fatty Acid; Hemoglobin; Ferritin; Iron Deficiency Anemia

Outcome Measures

Primary Outcomes (3)

• Short Chain Fatty Acid

  SCFA (acetate, propionate, and butyrate) levels in fresh feces of adolescent girls, using the GC-MS (Gas Chromatography-Mass Spectrometry) Method, were measured before (0 months) and after the intervention (2 months), using a ratio scale. The examination procedure included collecting feces in the field according to the procedure at https://drive.google.com/drive/folders/1uXklwFuC-1rnQ1Anim86b7-9pqLSheIz. Fresh feces samples were collected immediately, by storing them in a cool box (to maintain the quality of feces so that it remains stable during storage and transportation, and avoid the maturation process that can affect the results of lab tests, so that the results of the lab analysis carried out can be accurate and valid), and then immediately taken to the laboratory to quantify each of the short chain fatty acids (SCFA) in the sample.

  2 months after intervention

• hemoglobin

  Adolescent girls' hemoglobin values in the blood taken from the median cubital vein, using the hematology analyzer method (unit g/dl), were measured before (0 months) and after the intervention (2 months), using a ratio scale.

  2 months after intervention

• Ferritin

  Ferritin content in the blood of adolescent girls taken from the median cubital vein, using the Ferritin ELISA method (unit µg/L), was measured before (0 months) and after the intervention (2 months), using a ratio scale

  2 months after intervention

Secondary Outcomes (4)

• Nutrient intake

  2 months after intervention

• Nutritional status of adolescent girls (body mass index / age)

  2 months after intervention

• Menstrual cycle and duration of adolescent girls

  2 months after intervention

• Diarrhea

  2 months after intervention

Study Arms (2)

intervention group

ACTIVE COMPARATOR

Fresh cow's milk drink pasteurized at 72 °C, and fermented by kefir grain (5%) for 24 hours at 25 °C, then filtered to produce cow's milk kefir, and stored at 4 °C for 24 hours before drinking, given as 1 bottle/day of 120 ml + 10% liquid sugar for 2 months.

Combination Product: cow's milk kefir

control group

PLACEBO COMPARATOR

Fresh cow's milk drink pasteurized at 72 °C, without fermentation, given 1 bottle/day of 132 ml for 2 months

Combination Product: pasteurized cow's milk

Interventions

cow's milk kefir COMBINATION_PRODUCT

group given cow's milk kefir and blood supplement tablets (TTD)

Also known as: intervention group

intervention group

pasteurized cow's milk COMBINATION_PRODUCT

group given pasteurized cow's milk and blood supplement tablets (TTD)

Also known as: control group

control group

Eligibility Criteria

• Age: 15 Years - 18 Years
• Gender Eligibility Details: Adolescent girls as future mothers
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lusyana Gloria Doloksaribu: lead

Study Sites (1)

Gadjah Mada University

Yogyakarta, Special Region of Yogyakarta, 55281, Indonesia

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

Milk; Control Groups

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Lusyana Gloria Doloksaribu

CONTACT

085360637111; lusyanagloriadoloksaribu@mail.ugm.ac.id

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: In addition to participants, service providers, and outcomes assessors, it is also disguised from statisticians or data processors so that the data obtained does not become biased
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: doctoral students of the faculty of medicine, public health and nursing, Gadjah Mada University

Model Details: Its 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

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: May 4, 2025
• Study Start: May 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: May 1, 2026
• Last Updated: May 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: IPD can be obtained after the dissertation is registered at the Universitas Gadjah Mada Library or the Faculty of Medicine, Public Health, and Nursing Library
• Access Criteria: Only investigator

Locations

ID (1)