Assessment of Starch Digestibility and Amylase Sufficiency in Children

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

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.

Study Overview

• Status: Completed
• Conditions: Malnutrition, Child
• Intervention / Treatment: Other: Normal sorghum porridge, algal starch; Other: Normal sorghum porridge, algal dextrins; Other: Normal sorghum porridge, labeled flour; Other: Modified sorghum porridge, labeled flour; Other: Thinned sorghum porridge, labeled flour; Other: Modified sorghum porridge, octanoic acid

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Normal sorghum porridge, algal starch; Sorghum porridge with 13C-algal starch	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.
Experimental: Normal sorghum porridge, algal dextrins; Sorghum porridge with 13C-algal starch limit dextrins	Other: 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.
Experimental: Normal sorghum porridge, labeled flour; Sorghum porridge with 13C-labeled sorghum flour	Other: 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.
Experimental: Modified sorghum porridge, labeled flour; Modified sorghum porridge with 13C-labeled sorghum flour	Other: 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.
Experimental: Thinned sorghum porridge, labeled flour; Modified thinned sorghum porridge with 13C-labeled sorghum flour	Other: 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.
Experimental: Modified sorghum porridge, octanoic acid; Modified sorghum porridge with 13C-labeled octanoic acid	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Purdue University
• Collaborators: Baylor College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2012
• Primary Completion (Actual): December 31, 2014
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: March 10, 2018
• First Submitted That Met QC Criteria: March 10, 2018
• First Posted (Actual): March 16, 2018

Study Record Updates

• Last Update Posted (Actual): March 16, 2018
• Last Update Submitted That Met QC Criteria: March 10, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; Child Nutrition Disorders
• Other Study ID Numbers: 1209012695

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Not shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No