Efficacy of Zinc Fortified Fermented Wheat Flour

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

Interventions

DIETARY_SUPPLEMENT

Fermented High Zinc Wheat Flour Flatbread

* 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.

DIETARY_SUPPLEMENT

Unfermented High Zinc Wheat Flour Flatbread

* 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.

DIETARY_SUPPLEMENT

Post-Harvest Fortified Whole Wheat Flour Flatbread

* 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.

DIETARY_SUPPLEMENT

Low Zinc Whole Wheat Flour Flatbread (Control Group)

* 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.

Sponsors & Collaborators

• Bahauddin Zakariya University

  collaborator OTHER

• University of California

  collaborator OTHER

• The Hospital for Sick Children

  collaborator OTHER

• Aga Khan University

  lead OTHER

Principal Investigators

• Jai K Das · Aga Khan University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

10 Years

Max Age

40 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-01-01

Primary Completion

2024-05-31

Completion

2024-05-31

Countries

• Pakistan

Study Locations