Efficacy of Zinc Fortified Fermented Wheat Flour

NCT06092515 | Completed

• 1 other identifier: 2022-8164-23704
• Study Type: interventional
• Target: 1,044
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malnutrition; Diabetes; Inflammation; Conjunctivitis

Keywords

Zinc; Fortification; Micronutrient; Flour; Trial; Deficiencies

Outcome Measures

Primary Outcomes (7)

• Zinc Status

  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.

  Baseline and six months post intervention

• Fasting Blood Glucose

  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.

  Baseline and six months post-intervention.

• HbA1C Levels

  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.

  Baseline and six months post-intervention.

• Insulin Levels

  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.

  Baseline and six months post-intervention.

• Lipid Profiles

  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.

  Six months post-intervention.

• Zinc Deficiency (%)

  This primary outcome evaluates the prevalence of zinc deficiency among participants and it would be compared across the four groups.

  Baseline and six months post intervention

• Red blood cell membrane fatty acids concentrations

  This outcome measures the red blood cell membrane fatty acids concentrations as a percentage (%) and This would be compared across the four groups.

  At six months post intervention

Secondary Outcomes (7)

• 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

Study Arms (4)

Fermented High Zinc Wheat Flour Flatbread

EXPERIMENTAL

Participants in this arm will receive fermented whole wheat flatbreads made from wheat variants with a high zinc content, ranging. These flatbreads are prepared through traditional fermentation methods.

Dietary Supplement: Fermented High Zinc Wheat Flour Flatbread

Unfermented High Zinc Wheat Flour Flatbread

EXPERIMENTAL

Participants in this arm will receive unfermented whole wheat flatbreads made from wheat variants with a high zinc content. These flatbreads provide a source of bioavailable zinc without the fermentation process.

Dietary Supplement: Unfermented High Zinc Wheat Flour Flatbread

Fortified Wheat Flour flatbread

EXPERIMENTAL

Participants in this arm will receive flatbreads made from whole wheat flour fortified post-harvest to contain a zinc content

Dietary Supplement: Post-Harvest Fortified Whole Wheat Flour Flatbread

Low Zinc Wheat flatbread

ACTIVE COMPARATOR

Participants in this arm will receive whole wheat flatbreads made from wheat variants with a low zinc content

Dietary Supplement: Low Zinc Whole Wheat Flour Flatbread (Control Group)

Interventions

Fermented High Zinc Wheat Flour Flatbread DIETARY_SUPPLEMENT

* Participants in this group will receive flatbreads made from fermented high zinc wheat flour. * The flatbreads will be prepared using traditional fermentation methods. * These flatbreads will be provided to participants to consume daily, along with vegetables or pulses (daal), for six days a week over the course of six months.

Fermented High Zinc Wheat Flour Flatbread

Unfermented High Zinc Wheat Flour Flatbread DIETARY_SUPPLEMENT

* Participants in this group will receive flatbreads made from unfermented high zinc wheat flour, * The flatbreads will not undergo a fermentation process. * These flatbreads will be provided to participants to consume daily, along with vegetables or pulses (daal), for six days a week over the course of six months.

Unfermented High Zinc Wheat Flour Flatbread

Post-Harvest Fortified Whole Wheat Flour Flatbread DIETARY_SUPPLEMENT

* Participants in this group will receive flatbreads made from whole wheat flour fortified post-harvest * These fortified flatbreads will be provided to participants for daily consumption, along with vegetables or pulses (daal), for six days a week over the course of six months.

Fortified Wheat Flour flatbread

Low Zinc Whole Wheat Flour Flatbread (Control Group) DIETARY_SUPPLEMENT

* Participants in this group will serve as the control group. * They will receive flatbreads made from whole wheat flour with a low zinc content * These low zinc flatbreads will be provided to participants for daily consumption, along with vegetables or pulses (daal), for six days a week over the course of six months. six days a week over the course of six months.

Low Zinc Wheat flatbread

Eligibility Criteria

• Age: 10 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Adolescents aged 10-19 years
• Adult women aged 20-40 years.
• Wheat as a staple part of their diet

You may not qualify if:

• 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

Sponsors & Collaborators

• Aga Khan University: lead
• Bahauddin Zakariya University: collaborator
• University of California: collaborator
• The Hospital for Sick Children: collaborator

Study Sites (1)

Aga Khan University

Karachi, Sindh, 74800, Pakistan

Location

Related Publications (1)

• Das JK, Padhani ZA, Khan M, Mirani M, Rizvi A, Chauhadry IA, Yasin R, Ismail T, Akhtar S, Begum K, Iqbal J, Humayun K, Naseem HA, Malik KA, Bhutta ZA. Efficacy of Zinc Fortified and Fermented Wheat Flour (EZAFFAW): A randomized controlled trial protocol. PLoS One. 2024 Jun 20;19(6):e0304462. doi: 10.1371/journal.pone.0304462. eCollection 2024.

  PMID: 38900773 DERIVED

MeSH Terms

Conditions

Malnutrition; Diabetes Mellitus; Inflammation; Conjunctivitis

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Conjunctival Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Jai K Das

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor and Assistant Director

Model Details: This clinical trial investigates the health impact of consuming various types of wheat flour flatbreads among adolescent and adult females. The primary focus is on assessing zinc status and metabolic health in individuals at high risk of zinc deficiency and Type 2 Diabetes (T2DM). The study encompasses both fermented and unfermented flatbreads made from wheat variants with different zinc content and "post-harvest fortified wheat flour.

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: October 23, 2023
• Study Start: January 1, 2023
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: June 4, 2024

Record last verified: 2024-06

Locations

PA (1)