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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03467737
Enrollment
54
Registered
2018-03-16
Start date
2012-12-01
Completion date
2016-07-01
Last updated
2018-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malnutrition, Child

Brief 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.

Interventions

OTHERNormal 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.

OTHERNormal 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.

OTHERNormal 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.

OTHERModified 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.

OTHERThinned 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.

OTHERModified 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.

Sponsors

Baylor College of Medicine
CollaboratorOTHER
Purdue University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Months to 30 Months
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Alpha-amylase sufficiency in children3 hours after being fed test mealBreath test using 13C-tracer was used to assess alpha-amylase sufficiency in healthy and moderately malnourished children
Starch digestibility3 hours after being fed test mealBreath 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
Gastric emptying3 hours after being fed test mealBreath test using 13C-tracer in octanoic acid was used to assess gastric emptying in healthy and moderately malnourished children

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026