Zinc Resistant Starch Project

NCT01811836 | Completed DMC

• 1 other identifier: 201211114
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Enteropathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Enteropathy Measurement

  4 weeks

• Weight and Height Changes

  4 weeks (baseline and end)

• Number of participants with adverse events

  4 weeks

Study Arms (1)

Resistant Starch

EXPERIMENTAL

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

Interventions

Zinc DIETARY_SUPPLEMENT

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.

Also known as: Zinc Resistant Starch

Resistant Starch

Eligibility Criteria

• Age: 36 Months - 60 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Project Peanut Butter Factory

Blantyre, Malawi

Location

Related Publications (13)

• 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. doi: 10.1093/ajcn/75.6.1057.

  PMID: 12036813 BACKGROUND

• 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.

  PMID: 20496476 BACKGROUND

• 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.

  PMID: 8951265 BACKGROUND

• 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. doi: 10.1136/gut.44.4.483.

  PMID: 10075954 BACKGROUND

• 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. doi: 10.1056/NEJM199509283331304.

  PMID: 7651474 BACKGROUND

• Ruel MT, Rivera JA, Santizo MC, Lonnerdal 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. doi: 10.1542/peds.99.6.808.

  PMID: 9164774 BACKGROUND

• 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. doi: 10.1007/s00394-004-0540-9. Epub 2004 Nov 23.

  PMID: 16151969 BACKGROUND

• Turnlund JR. The use of stable isotopes in mineral nutrition research. J Nutr. 1989 Jan;119(1):7-14. doi: 10.1093/jn/119.1.7.

  PMID: 2643698 BACKGROUND

• 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. doi: 10.1093/jn/124.2.268.

  PMID: 8308576 BACKGROUND

• Meddings JB, Gibbons I. Discrimination of site-specific alterations in gastrointestinal permeability in the rat. Gastroenterology. 1998 Jan;114(1):83-92. doi: 10.1016/s0016-5085(98)70636-5.

  PMID: 9428222 BACKGROUND

• 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. doi: 10.1093/ajcn/82.5.1040.

  PMID: 16280436 BACKGROUND

• 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;30:43-48. doi: 10.1016/j.jtemb.2015.01.005. Epub 2015 Jan 21.

  PMID: 25744509 RESULT

• Ordiz MI, May TD, Mihindukulasuriya K, Martin J, Crowley J, Tarr PI, Ryan K, Mortimer E, Gopalsamy G, Maleta K, Mitreva M, Young G, Manary MJ. The effect of dietary resistant starch type 2 on the microbiota and markers of gut inflammation in rural Malawi children. Microbiome. 2015 Sep 3;3:37. doi: 10.1186/s40168-015-0102-9.

  PMID: 26334878 DERIVED

MeSH Terms

Conditions

Intestinal Diseases

Interventions

Zinc

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Mark Manary, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2013
• First Posted: March 15, 2013
• Study Start: March 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: August 2, 2018

Record last verified: 2018-07

Locations

MA (1)