Zinc Resistant Starch Project

Enteropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01811836
• Other study ID #: 201211114
• Status: Completed
• Phase: N/A
• Start date: March 2013
• Est. completion date: July 2013

Study information

• Verified date: July 2018
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 36 Months to 60 Months

Eligibility

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.

Related Conditions & MeSH terms

• Enteropathy
• Intestinal Diseases

Intervention

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.

Locations

Country	Name	City	State
Malawi	Project Peanut Butter Factory	Blantyre

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

Malawi, 

References & Publications (12)

Galpin L, Manary MJ, Fleming K, Ou CN, Ashorn P, Shulman RJ. Effect of Lactobacillus GG on intestinal integrity in Malawian children at risk of tropical enteropathy. Am J Clin Nutr. 2005 Nov;82(5):1040-5. — View Citation

Manary MJ, Abrams SA, Griffin IJ, Quimper MM, Shulman RJ, Hamzo MG, Chen Z, Maleta K, Manary MJ. Perturbed zinc homeostasis in rural 3-5-y-old Malawian children is associated with abnormalities in intestinal permeability attributed to tropical enteropathy. Pediatr Res. 2010 Jun;67(6):671-5. doi: 10.1203/PDR.0b013e3181da44dc. — View Citation

Manary MJ, Hotz C, Krebs NF, Gibson RS, Westcott JE, Broadhead RL, Hambidge KM. Zinc homeostasis in Malawian children consuming a high-phytate, maize-based diet. Am J Clin Nutr. 2002 Jun;75(6):1057-61. — View Citation

May T, Westcott C, Thakwalakwa C, Ordiz MI, Maleta K, Westcott J, Ryan K, Hambidge KM, Miller LV, Young G, Mortimer E, Manary MJ, Krebs NF. Resistant starch does not affect zinc homeostasis in rural Malawian children. J Trace Elem Med Biol. 2015 Apr;30:43 — View Citation

Meddings JB, Gibbons I. Discrimination of site-specific alterations in gastrointestinal permeability in the rat. Gastroenterology. 1998 Jan;114(1):83-92. — View Citation

Menzies IS, Zuckerman MJ, Nukajam WS, Somasundaram SG, Murphy B, Jenkins AP, Crane RS, Gregory GG. Geography of intestinal permeability and absorption. Gut. 1999 Apr;44(4):483-9. — View Citation

Miller LV, Hambidge KM, Naake VL, Hong Z, Westcott JL, Fennessey PV. Size of the zinc pools that exchange rapidly with plasma zinc in humans: alternative techniques for measuring and relation to dietary zinc intake. J Nutr. 1994 Feb;124(2):268-76. — View Citation

Ruel MT, Rivera JA, Santizo MC, Lönnerdal B, Brown KH. Impact of zinc supplementation on morbidity from diarrhea and respiratory infections among rural Guatemalan children. Pediatrics. 1997 Jun;99(6):808-13. — View Citation

Sazawal S, Bentley M, Black RE, Dhingra P, George S, Bhan MK. Effect of zinc supplementation on observed activity in low socioeconomic Indian preschool children. Pediatrics. 1996 Dec;98(6 Pt 1):1132-7. — View Citation

Sazawal S, Black RE, Bhan MK, Bhandari N, Sinha A, Jalla S. Zinc supplementation in young children with acute diarrhea in India. N Engl J Med. 1995 Sep 28;333(13):839-44. — View Citation

Turnlund JR. The use of stable isotopes in mineral nutrition research. J Nutr. 1989 Jan;119(1):7-14. Review. — View Citation

Yonekura L, Suzuki H. Effects of dietary zinc levels, phytic acid and resistant starch on zinc bioavailability in rats. Eur J Nutr. 2005 Sep;44(6):384-91. Epub 2004 Nov 23. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Net zinc balance	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	Enteropathy Measurement	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
Secondary	Weight and Height Changes	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)
Secondary	Number of participants with adverse events	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