EZAFFAW - Efficacy of Zinc Fortified Fermented Wheat Flour: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,044
- 试验地点
- 2
- 主要终点
- Zinc Status
研究概览
简要总结
Zinc is a pivotal micronutrient that participates in numerous essential metabolic pathways within the human body. Its multifaceted role makes the manifestations of zinc deficiency remarkably nonspecific and age-dependent. In children, zinc deficiency can manifest as growth retardation, cognitive impairment, recurrent infections, and other diverse symptoms. Adolescents and adults may experience fertility issues, work capacity impairment, and metabolic disorders due to zinc deficiency. Furthermore, zinc plays a crucial role in maintaining immune function, particularly in the elderly, where recurrent infections can be a notable outcome of deficiency. Given its fundamental importance, the potential benefits of zinc supplementation and fortification strategies have been explored, with some evidence indicating positive effects on health outcomes such as childhood mortality, diarrhea morbidity, and even risk factors for conditions like Type 2 Diabetes (T2DM) and cardiovascular disease (CVD). Understanding zinc's significance in these metabolic processes is vital for addressing deficiencies and improving public health.
A study is needed to assess the effect of various types of fermented and unfermented wheat flour flatbread and its impact on health including zinc status, anthropometric outcomes, risk of T2DM and CVD and morbidity on adolescent and adult females. The whole wheat flatbread trial would be ideal to inform policy as it is regularly consumed in Sindh as most people rely on chakki for wheat grinding and it is used commonly to make roti at home.
详细描述
STUDY DESIGN
This will be an individually randomized, double-blind efficacy trial in Mithi, District Tharparkar, Sindh, Pakistan. This district is among the most impoverished in Sindh, characterized by a tropical desert climate with extremely hot mornings. Approximately 87% of the population in Tharparkar lives below the poverty line. Due to its challenging demographics and environmental conditions, the region has endured severe droughts and faces the highest level of food insecurity among Sindh districts. It is concerning that 60% of children under five years suffer from stunting, 33.3% from wasting, and nearly 19.8% experience both conditions simultaneously. Additionally, approximately 40.4% of non-pregnant women of reproductive age are underweight. Tharparkar has been selected for this study due to its alarming rates of malnutrition and micronutrient deficiencies, making it an ideal location to assess the effectiveness of fortified wheat flour.
RESEARCH QUESTION
- Primary Does consumption of whole wheat flatbread made with fermented and unfermented 'high zinc wheat' or with 'post-harvest zinc-fortified wheat flour' improve zinc status and metabolic health among adolescents (10-19 years) and adult women (20-40 years) at high risk of zinc deficiency and T2DM compared to 'low zinc' whole wheat flatbread?
- Secondary Does an increase in bioavailable dietary zinc intake improve indicators for predicting the risk of T2DM in adolescents and adult women at high risk of zinc deficiency? SPECIFIC OBJECTIVES
- Primary To evaluate the efficacy of whole wheat flatbread made with fermented and unfermented 'high zinc wheat' or post-harvest zinc-fortified wheat on zinc status/zinc deficiency and metabolic health among adolescents and adult women at high risk of zinc deficiency when compared to the 'low zinc' whole wheat flatbread.
- Secondary To assess if an increase in bioavailable dietary zinc intake improves indicators for predicting the risk of T2DM in adolescents and adult women at high risk of zinc deficiency.
PARTICIPANTS The study will include adolescents (10-19 years) and adult women (20-40 years) INTERVENTION
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
This clinical trial will be conducted with a double-blind design
Participant Blinding:
Participants will not be informed about which specific type of flatbread they are receiving. Each participant will receive their assigned flatbread without knowledge of whether it falls into the fermented high zinc, unfermented high zinc, post-harvest fortified, or low zinc category.
Investigator and outcomes assessor Blinding:
The investigators and research staff responsible for data collection and assessment will also be unaware of the treatment assignments. They will not be involved in the preparation of the flatbreads to ensure that their observations and assessments are unbiased.
入排标准
- 年龄范围
- 10 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adolescents aged 10-19 years
- •Adult women aged 20-40 years.
- •Wheat as a staple part of their diet
排除标准
- •Severe Malnutrition
- •Pregnant or Lactating
- •Chronic Diseases
- •Participation in Similar Programs
- •Individuals taking vitamin or mineral supplements at the time of enrollment
- •Planned Relocation from the study area within the next 6-7
结局指标
主要结局
Zinc Status
时间窗: Baseline and six months post intervention
The primary outcome is the measurement of serum zinc status (micrograms per deciliter (μg/dL) in participants. This includes assessing the concentration of zinc in serum samples. Changes in serum zinc levels will be compared between the four intervention groups.
HbA1C Levels
时间窗: Baseline and six months post-intervention.
This measure evaluates HbA1C levels, expressed as a percentage (%). It provides insights into long-term blood glucose control, helping assess the impact of dietary interventions.
Fasting Blood Glucose
时间窗: Baseline and six months post-intervention.
This outcome assesses changes in participants' fasting blood glucose levels, measured in milligrams per deciliter (mg/dL). It aims to understand alterations in blood glucose levels resulting from flatbread interventions.
Zinc Deficiency (%)
时间窗: Baseline and six months post intervention
This primary outcome evaluates the prevalence of zinc deficiency among participants and it would be compared across the four groups.
Red blood cell membrane fatty acids concentrations
时间窗: At six months post intervention
This outcome measures the red blood cell membrane fatty acids concentrations as a percentage (%) and This would be compared across the four groups.
Insulin Levels
时间窗: Baseline and six months post-intervention.
This measure assesses participants' insulin levels, measured in microunits per milliliter (μU/mL). It helps in understanding changes in insulin sensitivity as a result of dietary interventions.
Lipid Profiles
时间窗: Six months post-intervention.
This measure assesses participants' lipid profiles, with the unit of measure to be specified (e.g., milligrams per deciliter, mg/dL). It provides insights into changes in lipid levels and their potential effects on overall body composition due to dietary interventions.
次要结局
- Change in Weight (kg)(Six months post intervention)
- Change in Height (m)(Six months post intervention)
- Change in BMI (kg/m²)(Six months post intervention)
- Acceptability and Adherence Assessment(Six months post intervention)
- School Attendance and Academic Performance(Six months post intervention)
- Morbidity(Six months post intervention)
- Anemia(Six months post intervention)
研究者
Dr Jai Kumar Das
Assistant Professor and Assistant Director
Aga Khan University