Gut Microbiota-Mediated Effects of Precision Dietary Interventions on Anemia Among Nepalese Adolescents
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
- INTRODUCTION Anemia represents one of the most significant global public health challenges, affecting an estimated 1.74 billion people worldwide, with disproportionately higher prevalence among adolescent girls and women of reproductive age.Adolescence constitutes a critical developmental window characterized by rapid growth velocity, increased iron requirements, and heightened physiological susceptibility, particularly among females due to the onset of menstruation. Iron deficiency anemia (IDA) during this developmental period has been associated with impaired cognitive function, reduced physical work capacity, compromised immune competence, and adverse reproductive health outcomes in later life .
While iron deficiency remains the predominant etiological factor for anemia globally, emerging evidence demonstrates that anemia represents a complex, multifaceted disorder influenced by nutritional quality, inflammatory status, infectious disease burden, and biological variables including gut microbiota composition.The gut microbiome has emerged as a critical regulator of systemic iron homeostasis through multiple mechanistic pathways: (1) direct competition with the host for luminal iron; (2) modulation of intestinal inflammation and barrier function; (3) production of short-chain fatty acids (SCFAs), particularly butyrate, which influence hepcidin expression and iron absorption; and (4) immune-mediated regulation of iron absorption.
We hypothesize that dietary patterns, particularly vegetarian diets prevalent in South Asian populations, alter gut microbiota composition toward phyla producing higher levels of butyrate and propionate, which may down-regulate hepcidin expression and enhance intestinal iron absorption. Conversely, dysbiosis of microbiota profiles characterized by pathogenic overgrowth may promote intestinal inflammation, up-regulate hepcidin, and impair iron bioavailability despite adequate dietary intake.
South Asia bears one of the highest burdens of adolescent anemia globally, with over 50% of adolescent girls affected according to UNICEF and WHO estimates . This elevated prevalence results from the convergence of multiple risk factors: monotonous cereal-based diets with low bioavailable iron content, gender-based nutritional inequities, inadequate sanitation infrastructure, high prevalence of soil-transmitted helminth infections, and limited dietary diversity. Although Weekly Iron-Folic Acid Supplementation (WIFAS) programs have been implemented throughout the region, their efficacy in reducing anemia prevalence has demonstrated limited success, suggesting that traditional supplementation approaches may be insufficient to address the biological complexity and underlying determinants of anemia in this population.
Recent advances in nutritional science have highlighted the bidirectional relationship between iron supplementation and gut microbiota composition. Oral iron supplementation has been demonstrated to alter intestinal microbial ecology, potentially promoting pathogenic bacterial proliferation and intestinal inflammation, which may paradoxically impair iron absorption and increase gastrointestinal side effects. These findings underscore the critical importance of understanding diet-microbiome interactions when developing contextually appropriate anemia interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 15 Years 至 19 Years(Child, Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Standard supplementation
Weekly iron-folic acid tablets with enhanced monitoring
干预措施: Iron folic acid supplement (Drug)
Control (standard care)
Nutrition education on anemia prevention and control
干预措施: Nutrition education on anemia prevention and control (Behavioral)
Goat liver supplementation
50 grams Cooked goat liver three times per week
干预措施: Goat liver supplementation (Dietary Supplement)
结局指标
主要结局
未指定
次要结局
- Improved Diet(12 weeks)
研究者
Rubina Karki
Principal Investigator
Southern Medical University, China
