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
Broad - to examine the result of feeding RS to 3-5 year old rural Malawian children on zinc homeostasis and environmental enteropathy (EE).
- To measure zinc status using a dual zinc stable isotope assay before and after administering resistant starch (RS) in 20 children.
- To measure intestinal function using a site-specific sugar absorption test before and after administering RS in 20 children.
- To determine the relationship between RS and zinc homeostasis.
- To determine the relationship between RS and environmental enteropathy.
|Condition or disease||Intervention/treatment||Phase|
|Enteropathy||Dietary Supplement: Zinc||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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.
- 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.
- 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.
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
|Project Peanut Butter Factory|
|Principal Investigator:||Mark Manary, MD||Washington University School of Medicine|