Zinc Resistant Starch Project

July 31, 2018 updated by: Washington University School of Medicine

The Effect of Resistant Starch Consumption on Zinc Hemostasis in Malawian Children at Risk for Zinc Deficiency

Broad - to examine the result of feeding RS to 3-5 year old rural Malawian children on zinc homeostasis and environmental enteropathy (EE).

Specific -

  1. To measure zinc status using a dual zinc stable isotope assay before and after administering resistant starch (RS) in 20 children.
  2. To measure intestinal function using a site-specific sugar absorption test before and after administering RS in 20 children.
  3. To determine the relationship between RS and zinc homeostasis.
  4. To determine the relationship between RS and environmental enteropathy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A total of 20 (10 M, 10 F) stunted rural Malawian children aged 36-60 months will be studied to determine if there is an effect of feeding RS on zinc homeostasis and environmental enteropathy. These children are at high risk for zinc deficiency and environmental enteropathy by their demographic characteristics. Children will first have a quantitative assessment of zinc homeostasis where each child is given 2 zinc stable isotopes, one by mouth and another intravenously, which is followed by a stool and urine collection of 4 days. Zinc isotopes are quantified in the feces and urine, and these values are used to calculate the primary outcome, net zinc balance. This is followed by an assessment of environmental enteropathy quantitatively measured using the non-invasive site specific sugar absorption test, where each child drinks 100 mL of a sugar solution and a urine collection follows. The quantities of non-metabolizable sugars are measured, and the ratio of two of the sugars, lactulose and mannitol, is a measure of environmental enteropathy. Then the children will receive a dietary supplement, corn starch that has been modified to reduce its dietary absorption, for 5 weeks, which they will add to their phala. The RS is a standard food product that has been used safely in many millions of people for several decades. After taking this RS for 4 weeks both the zinc stable isotope test and the dual sugar absorption test will be repeated on the children to see if they have improved. These results will offer preliminary data as to whether RS might be used effectively on a large scale in the community to alleviate zinc deficiency and/or environmental enteropathy.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malawi
      • Blantyre, Malawi
        • Project Peanut Butter Factory

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 5 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Any stunted, otherwise healthy child aged 36-60 months living close to the Chipalonga Health Center. Stunting will be defined as height-for-age Z-score (HAZ) < -2. Children will be selected on the basis of having the lowest weight-for-height Z-scores (WHZ), and by dietary surveys on which their caretakers report consuming animal source foods < twice per month. Previous field work indicates about 80% of children are stunted and almost all children consume animal source foods < twice per month.

Exclusion Criteria:

  • Children who are not permanent residents in the village. Additionally, children with severe chronic illness such as cerebral palsy, and those who are receiving other supplementary food, or those who are participating in another research study are all ineligible to participate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Resistant Starch

Oral and intravenous zinc stable isotopes. Zinc: 67Zn (>97% enrichment),68Zn (>99% enrichment) and 70Zn (>95% enrichment) Days 1 and 38: children will be administered 40-75 μg of 67Zn through consumed food. At the end of these days, children will be given an intravenous injection of an accurately measured quantity of ~800 μg of 68Zn.

Days 3-35: resistant starch feeding -- which will be given to mothers and integrated into the food.
Dietary supplement: Zinc
Children will have an assessment of zinc homeostasis; each child is given 2 zinc stable isotopes, one by mouth and one intravenously, followed by a stool and urine collection (4 days.) Zinc isotopes are quantified in the feces and urine, values are used to calculate the primary outcome, net zinc balance. An assessment of EE quantitatively measured using the non-invasive site specific sugar absorption test, each child drinks 100 mL of a sugar solution and a urine collection follows. The quantities of non-metabolizable sugars are measured, and the ratio of two of the sugars, lactulose and mannitol, is a measure of environmental enteropathy. Children will receive a dietary supplement, corn starch, modified to reduce its absorption, for 5 weeks, which they will add to their phala. The RS is a standard food and has been used safely in millions of people for years. After taking this RS for 4 weeks both the zinc stable isotope test and the dual sugar absorption test will be repeated.
Other Names:
  • Zinc Resistant Starch

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Net zinc balance
Time Frame: 4 weeks
Zinc isotopes are quantified in the feces and urine, and these values are used to calculate net zinc balance. taking this RS for 4 weeks both the zinc stable isotope test and the dual sugar absorption test will be repeated on the children to see if they have improved. These results will offer preliminary data as to whether RS might be used effectively on a large scale in the community to alleviate zinc deficiency and/or environmental enteropathy.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Enteropathy Measurement
Time Frame: 4 weeks
Environmental enteropathy quantitatively measured using the non-invasive site specific sugar absorption test, where each child drinks 100 mL of a sugar solution and a urine collection follows. The quantities of non-metabolizable sugars are measured, and the ratio of two of the sugars, lactulose and mannitol, is a measure of environmental enteropathy.
4 weeks
Weight and Height Changes
Time Frame: 4 weeks (baseline and end)

Weight and height will be measured initially and at each visit to measure any changes over the period.

These outcomes will be measured at baseline enrollment and at the end of the study.
4 weeks (baseline and end)
Number of participants with adverse events
Time Frame: 4 weeks
Measure the safety of zinc resistant starch. The RS is a standard food product that has been used safely in many millions of people for several decades.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2013

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

March 7, 2013

First Submitted That Met QC Criteria

March 12, 2013

First Posted (Estimate)

March 15, 2013

Study Record Updates

Last Update Posted (Actual)

August 2, 2018

Last Update Submitted That Met QC Criteria

July 31, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201211114

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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