Assessment of Starch Digestibility and Amylase Sufficiency in Children

Malnutrition, Child Clinical Trial

Official title:

Assessing Malian and U.S. Children for Starch Digestion and Amylase Sufficiency and Identifying Better Energy Providing Foods for Growth and Recovery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03467737
• Other study ID #: 1209012695
• Status: Completed
• Phase: N/A
• First received: March 10, 2018
• Last updated: March 10, 2018
• Start date: December 1, 2012
• Est. completion date: July 1, 2016

Study information

• Verified date: March 2018
• Source: Purdue University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Research has demonstrated that there is a relationship between malnourishment and insufficient production of pancreatic enzymes, such as α-amylase which digests starch into glucose. Starchy foods that can be easily digested into glucose are critical to the development child for energy and proper growth. This study investigated the use of a noninvasive breath test for the assessment of amylase sufficiency, digestibility of normal and modified sorghum porridges and gastric emptying rate of a sorghum porridge in Malian and U.S. children.

Description:

The purpose of this research is to test the hypotheses that: 1.) Moderately malnourished stunted children have low pancreatic α-amylase activity; and 2.) Modified starchy food preparations will have better (higher) digestibility than the commonly given foods for both moderately malnourished stunted and healthy non-stunted children. A noninvasive breath test was used to assess amylase insufficiency in moderately malnourished and stunted children in Mali, as well as in healthy children in Mali and the United States. Moderately malnourished and healthy children in Mali were fed sorghum porridges, which are commonly consumed in Mali. Porridges contained a 13C-labeled substrate (algal starch or octanoic acid) for assessment of amylase insufficiency and gastric emptying rate. In a follow-up study, healthy children in the United States were also assessed for amylase sufficiency.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: July 1, 2016
• Est. primary completion date: December 31, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Months to 30 Months

Eligibility

Inclusion Criteria:

• Stunted weaned children in the age range 18 - 30 months with height-for-age Z-score (HAZ) below -2 (HAZ<-2)

• Healthy, weaned children 18-30 months of age for study 1

• Healthy, weaned children up to 5 years old

Exclusion Criteria:

• Acutely ill and wasted child with weight for height lower than -2 z-score

• No medical problems other than their malnutrition status

• No medications

Related Conditions & MeSH terms

• Child Nutrition Disorders
• Malnutrition
• Malnutrition, Child

Intervention

Other:
• Normal sorghum porridge, algal starch
Normal sorghum porridge with 13C-labeled algal starch was fed, breath tested, as the first arm of an alpha-amylase sufficiency assessment in healthy and moderately malnourished children.
• Normal sorghum porridge, algal dextrins
Normal sorghum porridge with 13C-labeled starch limit dextrins was fed, breath tested, as the second arm of an alpha-amylase sufficiency assessment in healthy and moderately malnourished children.
• Normal sorghum porridge, labeled flour
Normal sorghum porridge with a portion of 13C-labeled sorghum flour was fed, breath tested, for starch digestibility assessment in healthy and moderately malnourished children.
• Modified sorghum porridge, labeled flour
Modified sorghum porridge with shear stirring to reduce viscosity with a portion of 13C-labeled sorghum flour was fed, breath tested, for starch digestibility assessment in healthy and moderately malnourished children.
• Thinned sorghum porridge, labeled flour
Thinned sorghum porridge treated with an alpha-amylase liquifying enzyme with a portion of 13C-labeled sorghum flour was fed, breath tested, for starch digestibility assessment in healthy and moderately malnourished children.
• Modified sorghum porridge, octanoic acid
Modified sorghum porridge with shear stirring to reduce viscosity with addition of 13C-labeled octanoic acid was fed, breath tested, for gastric emptying assessment in healthy and moderately malnourished children.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Purdue University	Baylor College of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alpha-amylase sufficiency in children	Breath test using 13C-tracer was used to assess alpha-amylase sufficiency in healthy and moderately malnourished children	3 hours after being fed test meal
Primary	Starch digestibility	Breath test using 13C-tracer in labeled sorghum flour was used to assess starch digestibility of three different prepared sorghum porridges of different thicknesses in healthy and moderately malnourished children	3 hours after being fed test meal
Primary	Gastric emptying	Breath test using 13C-tracer in octanoic acid was used to assess gastric emptying in healthy and moderately malnourished children	3 hours after being fed test meal