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Zinc Resistant Starch Project

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ClinicalTrials.gov Identifier: NCT01811836
Recruitment Status : Completed
First Posted : March 15, 2013
Last Update Posted : August 2, 2018
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Enteropathy Dietary Supplement: Zinc Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Resistant Starch Consumption on Zinc Hemostasis in Malawian Children at Risk for Zinc Deficiency
Actual Study Start Date : March 2013
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine


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 Name: Zinc Resistant Starch




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


  3. 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.



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Ages Eligible for Study:   36 Months to 60 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01811836


Locations
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Malawi
Project Peanut Butter Factory
Blantyre, Malawi
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Mark Manary, MD Washington University School of Medicine

Publications of Results:
Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01811836     History of Changes
Other Study ID Numbers: 201211114
First Posted: March 15, 2013    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: July 2018
Additional relevant MeSH terms:
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Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Zinc
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs