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Completed

NCT Number: NCT03467737

Assessment of Starch Digestibility and Amylase Sufficiency in Children

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.

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Key information

Conditions

Malnutrition, Child Child Nutrition Disorders Nutrition Disorders Nutritional and Metabolic Diseases

Age range

18 month–30 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Normal sorghum porridge, algal starch

Other

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

Other

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

Other

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

Other

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

Other

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

Other

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.

Primary outcomes

  1. Alpha-amylase sufficiency in children

    Time frame: 3 hours after being fed test meal

    Breath test using 13C-tracer was used to assess alpha-amylase sufficiency in healthy and moderately malnourished children

  2. Starch digestibility

    Time frame: 3 hours after being fed test meal

    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. Gastric emptying

    Time frame: 3 hours after being fed test meal

    Breath test using 13C-tracer in octanoic acid was used to assess gastric emptying in healthy and moderately malnourished children

Sponsors and collaborators

Lead sponsor

Purdue University

Other

Collaborators

  • Baylor College of Medicine

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2016
First posted
Mar 16, 2018
Registry last updated
Mar 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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