Clinical Trials Directory

Trials / Completed

CompletedNCT03467737

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
54 (actual)
Sponsor
Purdue University · Academic / Other
Sex
All
Age
18 Months – 30 Months
Healthy volunteers
Accepted

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.

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.

Conditions

Interventions

TypeNameDescription
OTHERNormal sorghum porridge, algal starchNormal 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.
OTHERNormal sorghum porridge, algal dextrinsNormal 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.
OTHERNormal sorghum porridge, labeled flourNormal sorghum porridge with a portion of 13C-labeled sorghum flour was fed, breath tested, for starch digestibility assessment in healthy and moderately malnourished children.
OTHERModified sorghum porridge, labeled flourModified 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.
OTHERThinned sorghum porridge, labeled flourThinned 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.
OTHERModified sorghum porridge, octanoic acidModified 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.

Timeline

Start date
2012-12-01
Primary completion
2014-12-31
Completion
2016-07-01
First posted
2018-03-16
Last updated
2018-03-16

Source: ClinicalTrials.gov record NCT03467737. Inclusion in this directory is not an endorsement.