How Precision Diets, Through Gut Bacteria, Affect Anemia in Nepalese Adolescent

ConditionAnemia
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age15-19
SponsorSouthern Medical University, China

About this trial

This study aims to evaluate whether a food-based nutrition intervention using goat liver can improve anemia among adolescent girls in Kathmandu, Nepal, and compare its effectiveness with the current standard iron and folic acid supplementation. It will also investigate how diet and the gut microbiota (the community of beneficial microorganisms living in the intestine) may influence iron absorption and response to treatment.

Anemia is a major public health problem among adolescent girls in Nepal. During adolescence, rapid growth and the onset of menstruation increase the body's need for iron and other nutrients involved in blood formation. If left untreated, anemia can impair physical growth, reduce learning ability and concentration, decrease work capacity, weaken immunity, and negatively affect future reproductive health. Although weekly iron-folic acid supplementation programs are widely implemented, anemia remains common, suggesting that additional strategies may be needed.

Recent research indicates that gut microbiota may affect iron metabolism by influencing nutrient absorption, inflammation, and overall intestinal health. Dietary habits can alter the composition of gut bacteria, which may partly explain why individuals respond differently to iron interventions. However, little is known about these relationships among Nepalese adolescents. This study seeks to fill that knowledge gap and explore whether a locally available food-based intervention can provide a practical and sustainable alternative or complement to conventional supplementation.

The research will be conducted among adolescent girls aged 15 to 19 years enrolled in selected schools in Kathmandu. The study has two phases. In the first phase, you will undergo screening to determine the prevalence and types of anemia. Blood samples will be collected to measure hemoglobin, iron status, vitamin B12, folate, and inflammation-related biomarkers. Stool samples will be collected to analyze gut microbiota composition. Information on dietary intake, food frequency, dietary diversity, and other relevant characteristics will also be obtained through structured questionnaires.

Girls identified with anemia and meeting the eligibility criteria will be invited to participate in the randomized intervention phase. You will be randomly assigned to receive either the standard iron-folic acid supplementation recommended by national programs or a goat liver-based dietary intervention for 12 weeks. Random assignment ensures a fair comparison between interventions and minimizes bias.

Goat liver was selected because it is rich in highly bioavailable heme iron as well as vitamin B12, folate, vitamin A, and other nutrients important for blood production. As a commonly available food in Nepal, it may represent a culturally acceptable and sustainable nutrition-based strategy for improving anemia.

During the intervention, you will be monitored regularly to assess adherence and wellbeing. At the end of the 12-week period, blood and stool samples will be collected again to evaluate changes in hemoglobin levels, iron-related biomarkers, nutritional status, and gut microbiota composition. The study will compare improvements between intervention groups and examine whether changes in gut microbiota are associated with better anemia outcomes.

Participation is entirely voluntary. Written informed consent from parents or guardians and informed assent from adolescent participants will be obtained before enrollment. You may withdraw from the study at any time without penalty. All personal information and laboratory results will remain confidential and will be stored using coded identifiers to protect privacy.

Blood collection will be performed by trained healthcare professionals using standard safety procedures, and stool samples will be collected using appropriate collection kits and instructions. Participants found to have severe anemia or other important medical conditions during the study will be referred for appropriate medical care according to national guidelines.

The findings from this study are expected to provide important evidence on whether a locally available food-based intervention can effectively improve anemia among adolescent girls while also enhancing understanding of the relationship between diet, gut microbiota, and iron metabolism. The results may help inform future nutrition policies, school health programs, and precision nutrition strategies for anemia prevention and treatment in Nepal and other similar settings.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female adolescents aged 15-19 years

Enrolled in selected schools

Resident in Kathmandu for at least 6 months

Provision of written informed assent and parental consent

Disqualifiers

Current pregnancy

Known genetic blood disorders (thalassemia, sickle cell disease)

Chronic metabolic, inflammatory, or infectious diseases affecting hematological parameters

Acute illness at time of screening

Trial design

Design model

Parallel

Treatments tested in this trial

  • Iron folic acid supplement

    Drug

    Weekly iron-folic acid tablets with enhanced monitoring

  • Goat liver supplementation

    Dietary supplement

    50 gms Cooked goat liver three times per week

  • Nutrition education on anemia prevention and control

    Behavioral

    Nutrition education on anemia prevention and control once a week

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Control (standard care)Other 1 intervention
Group B: Standard supplementationExperimental treatment 1 intervention
Group C: Goat liver supplementationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in hemoglobin concentration

The main measure of whether the intervention successfully treats anemia. Hemoglobin will be measured using the cyanmethemoglobin method at baseline and after the 12-week intervention period. The study is powered to detect a minimum clinically important difference of 1.2 g/dL, representing a shift from moderate to mild anemia classification per WHO criteria.

Time frame
12 weeks

Secondary outcomes

1

Serum ferritin levels

Measures iron stores in the body. Will be assessed using electrochemiluminescence immunoassay (ECLIA) and adjusted for inflammation status (CRP and AGP) using BRINDA project recommendations to obtain accurate iron deficiency classification

Time frame
12 weeks
2

Serum transferrin receptor (sTfR)

An additional marker of iron status that reflects tissue iron deficiency, particularly useful when inflammation is present. Measured by ELISA.

Time frame
12 weeks
3

Serum folate concentration

Assesses folate status to identify megaloblastic anemia and evaluate whether goat liver (rich in natural folates) improves folate levels compared to synthetic folic acid tablets. Measured by chemiluminescent immunoassay. Deficiency defined as \<3 ng/mL (\<6.8 nmol/L) per WHO guidelines.

Time frame
12 weeks
4

Gut microbiota composition

Exploratory/secondary outcome. 16S rRNA gene sequencing of the V4 hypervariable region will assess: alpha diversity (Shannon index, observed ASVs, Faith's phylogenetic diversity); beta diversity (Bray-Curtis and weighted UniFrac distances); and differential abundance of specific taxa (using DESeq2). Stool samples collected using OMNIgene-GUT tubes.

Time frame
12 weeks

Other outcomes

Sponsors and contacts

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