Zinc Resistant Starch Project
Condition: Enteropathy
MeSH terms: Intestinal Diseases
Study type: Interventional

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.
    

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.
    

Intervention name(s): Zinc
Intervention type(s): Dietary Supplement
Intervention description(s): 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 intervention name(s): Zinc Resistant Starch
Intervention MeSH terms: Zinc
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment