How Precision Diets, Through Gut Bacteria, Affect Anemia in Nepalese Adolescent
NCT07661602 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2026-06-25
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
Interventions
- DRUG
-
Iron folic acid supplement
Weekly iron-folic acid tablets with enhanced monitoring
- DIETARY_SUPPLEMENT
-
Goat liver supplementation
50 gms Cooked goat liver three times per week
- BEHAVIORAL
-
Nutrition education on anemia prevention and control
Nutrition education on anemia prevention and control once a week
Sponsors & Collaborators
-
Southern Medical University, China
lead OTHER
Principal Investigators
-
Longying Zha, Post Doctorate · Southern Medical University, China
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 15 Years
- Max Age
- 19 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-07-31
- Primary Completion
- 2026-08-31
- Completion
- 2026-11-30
Countries
- Nepal
Study Locations
More Related Trials
-
Bhaktapur Maternal and Child Micronutrient Study
NCT03285399 ·Status: COMPLETED
-
Action Against Malnutrition Through Agriculture (AAMA) Plus MNP Study
NCT01488305 ·Status: COMPLETED ·Phase: NA
-
Evaluating of the Impact of Micronutrient Interventions Among Adolescents in Mozambique
NCT06815315 ·Status: COMPLETED ·Phase: NA
-
Sub Regional Micronutrient Survey in Ethiopia
NCT03353662 ·Status: UNKNOWN
-
Etiology of Anemia Among Preschool Children in Ethiopia
NCT05626647 ·Status: COMPLETED
-
Nutritional Status and Bouillon Use in Northern Ghana
NCT04632771 ·Status: COMPLETED
-
Evaluation of a Healthy Food Procurement Policy at Municipality-level in Nepal
NCT05664256 ·Status: RECRUITING ·Phase: NA
-
Effect of Hookworm Elimination and Vitamin A Intervention on Iron Status of Preschool Children in Sichuan, China
NCT02675140 ·Status: COMPLETED ·Phase: PHASE4
-
Microbiota Directed Food for Children With Severe Acute Malnutrition
NCT06308848 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Dietary Intake of Folic Acid and Vitamin B12 Among Teenage Girls - Validation of Food Frequency Questionnaire
NCT06094023 ·Status: RECRUITING
-
Targeting School Feeding Programs at Vulnerable Sub-Groups
NCT01261182 ·Status: COMPLETED ·Phase: NA
-
Anemia Etiology Evaluation in Ethiopia
NCT04002466 ·Status: COMPLETED
-
Nutrition Intervention Among Ethnic Minority Children Aged 5-16 Years in Tra Vinh Province, Vietnam
NCT07583667 ·Status: COMPLETED ·Phase: NA
-
Distribution of Fortified Yoghurt in Senegal to Decrease Children's Anemia and Improve Milk Supply
NCT02079961 ·Status: COMPLETED ·Phase: EARLY_PHASE1
-
Compliance With Dietary Recommendations in Children at Risk for Undernutrition
NCT01658267 ·Status: COMPLETED ·Phase: PHASE3
-
Iron Absorption From a Micronutrient Powder Containing Galacto-oligosaccharides (GOS)
NCT02666417 ·Status: COMPLETED ·Phase: NA
-
Effect of Household Use of Multiple Micronutrient-fortified Bouillon on Micronutrient Status Among Women and Children in Two Districts in the Northern Region of Ghana
NCT05178407 ·Status: COMPLETED ·Phase: NA
-
Introduction of MMS to Antenatal Care in Bamako, Mali
NCT05312242 ·Status: COMPLETED ·Phase: NA
-
Impact of eHealth Education to Reduce Anemia Among School-going Adolescent Girls in Rural Bangladesh
NCT05185661 ·Status: COMPLETED ·Phase: NA
-
The Maternal EED Study
NCT05862363 ·Status: RECRUITING ·Phase: NA
-
Evaluating Oral Nutritional Supplements on Children's Nutritional Status and Digestive Health in Vietnam.
NCT05551637 ·Status: COMPLETED ·Phase: NA
-
Effect of Iron Versus Multiple Micronutrient Supplementation on Anemia in Preschool Children of Malaria-Endemic Area
NCT00628459 ·Status: COMPLETED ·Phase: NA
-
Antenatal Micronutrient Supplementation and Birth Weight
NCT00115271 ·Status: COMPLETED ·Phase: PHASE3
-
Project Grow Smart: Intervention Trial of Multiple Micronutrients and Early Learning Among Infants in India
NCT01660958 ·Status: COMPLETED ·Phase: NA
-
Early Life Nutritional Exposures and Long-term Health and Cognitive Outcomes
NCT01979770 ·Status: COMPLETED