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

NCT07661602 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: 251-2026
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anemia

Keywords

Anaemia; iron deficiency anemia; adolescent girls; goat liver supplementation; food-based intervention; precision nutrition; gut microbiome; dietary intervention

Outcome Measures

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.

  12 weeks

Secondary Outcomes (6)

• Serum ferritin levels

  12 weeks

• Serum transferrin receptor (sTfR)

  12 weeks

• Serum folate concentration

  12 weeks

• Gut microbiota composition

  12 weeks

• Improved Diet

  12 weeks

Study Arms (3)

Control (standard care)

OTHER

Nutrition education on anemia prevention and control

Behavioral: Nutrition education on anemia prevention and control

Standard supplementation

EXPERIMENTAL

Weekly iron-folic acid tablets with enhanced monitoring

Drug: Iron folic acid supplement

Goat liver supplementation

EXPERIMENTAL

50 grams Cooked goat liver three times per week

Dietary Supplement: Goat liver supplementation

Interventions

Goat liver supplementation DIETARY_SUPPLEMENT

50 gms Cooked goat liver three times per week

Goat liver supplementation

Nutrition education on anemia prevention and control BEHAVIORAL

Nutrition education on anemia prevention and control once a week

Control (standard care)

Iron folic acid supplement DRUG

Weekly iron-folic acid tablets with enhanced monitoring

Standard supplementation

Eligibility Criteria

• Age: 15 Years - 19 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• Use of iron, folic acid, vitamin B12 supplements, antibiotics, or probiotics within the past 3 months
• History of helminth infection or deworming treatment within the past 6 months
• Participation in other nutrition intervention studies

Sponsors & Collaborators

• Southern Medical University, China: lead

Study Sites (1)

Valley View School

Kathmandu, Bagmati, 44600, Nepal

Location

Related Publications (1)

• Kassebaum NJ, Jasrasaria R, Naghavi M, Wulf SK, Johns N, Lozano R, Regan M, Weatherall D, Chou DP, Eisele TP, Flaxman SR, Pullan RL, Brooker SJ, Murray CJ. A systematic analysis of global anemia burden from 1990 to 2010. Blood. 2014 Jan 30;123(5):615-24. doi: 10.1182/blood-2013-06-508325. Epub 2013 Dec 2.

  PMID: 24297872 RESULT

Related Links

• A systematic analysis of global anemia burden from 1990 to 2010
• The global prevalence of anaemia in 2011
• Iron biology in immune function, muscle metabolism and neuronal functioning
• Maternal and child undernutrition and overweight in low-income and middle-income countries
• The effects of iron fortification and supplementation on the gut microbiome and diarrhea in infants and children: a review
• Altered fecal microbial and metabolic profile reveals potential mechanisms underlying iron deficiency anemia in pregnant women in China
• Nutritional iron deficiency
• Prevalence of anemia and its associated factors among school-going adolescent girls in schools of Dhankuta municipality, Nepal
• Dietary intake patterns and nutritional status of women of reproductive age in Nepal: findings from a health survey
• Evidence-based interventions for improvement of maternal and child nutrition: what can be done and at what cost?
• Iron fortification adversely affects the gut microbiome, increases pathogen abundance and induces intestinal inflammation in Kenyan infants
• Nepal demographic and health survey 2022: Key indicators. (2022).
• Factors associated with anaemia in a nationally representative sample of nonpregnant women of reproductive age in Nepal
• A review of phytate, iron, zinc, and calcium concentrations in plant-based complementary foods used in low-income countries and implications for bioavailability
• The Proportion of Anemia Associated with Iron Deficiency in Low, Medium, and High Human Development Index Countries: A Systematic Analysis of National Surveys
• The prevalence of anemia and iron deficiency is more common in breastfed infants than their mothers in Bhaktapur, Nepal
• Prevalence of anemia and its associated factors among adolescent girls on Weekly Iron Folic Acid supplementation (WIFAS) implemented and non-implemented schools at Tokha municipality, Kathmandu
• Micronutrients deficiencies and its correlation with the soil-transmitted helminthic infections among children and non-pregnant women in Nepal: findings from Nepal national micronutrient status survey
• Where is Nepal in the nutrition transition?
• Differential human gut microbiome assemblages during soil-transmitted helminth infections in Indonesia and Liberia
• A simple sample size formula for analysis of covariance in randomized clinical trials
• Repeated measures in clinical trials: analysis using mean summary statistics and its implications for design
• Methodologic approach for the Biomarkers Reflecting Inflammation and Nutritional Determinants of Anemia (BRINDA) project
• WHO guideline on use of ferritin concentrations to assess iron status in individuals and populations
• Case Report: Vitamin B12 deficiency in an adolescent female with Polycystic Ovarian Syndrome
• Serum and red blood cell folate concentrations for assessing folate status in populations
• Iron metabolism in man
• Intestinal absorption of hemoglobin iron-heme cleavage by mucosal heme oxygenase
• Iron bioavailability and dietary reference values
• Indian Food Composition Tables (2017).
• Folate bioavailability
• Folic acid and L-5-methyltetrahydrofolate: comparison of clinical pharmacokinetics and pharmacodynamics
• Folic acid fortification and public health: report on threshold doses above which unmetabolised folic acid appear in serum

MeSH Terms

Conditions

Anemia; Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

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

Study Officials

• Longying Zha, Post Doctorate

  Southern Medical University, China

  STUDY DIRECTOR

Central Study Contacts

Rubina Karki, PhD scholar

CONTACT

+977 9841899303; rubukarki4@gmail.com

Prateek Joshi, MSc

CONTACT

+977 9841220104; prateeklokanthali@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 22, 2026
• Study Start: July 1, 2026
• Primary Completion: August 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)