Assessment of Starch Digestibility and Amylase Sufficiency in Children

Purdue University

Status: Completed

Conditions: Malnutrition, Child

Treatments: Other: Normal sorghum porridge, algal dextrins; Other: Thinned sorghum porridge, labeled flour; Other: Modified sorghum porridge, labeled flour; Other: Normal sorghum porridge, algal starch; Other: Modified sorghum porridge, octanoic acid; Other: Normal sorghum porridge, labeled flour

Study type: Interventional

Funder types: Other

Identifiers

NCT03467737

1209012695

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: All

Ages: 18 to 30 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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54 participants in 6 patient groups

Normal sorghum porridge, algal starch

Experimental group

Description:

Sorghum porridge with 13C-algal starch

Treatment:

Other: Normal sorghum porridge, algal starch

Normal sorghum porridge, algal dextrins

Experimental group

Description:

Sorghum porridge with 13C-algal starch limit dextrins

Treatment:

Other: Normal sorghum porridge, algal dextrins

Normal sorghum porridge, labeled flour

Experimental group

Description:

Sorghum porridge with 13C-labeled sorghum flour

Treatment:

Other: Normal sorghum porridge, labeled flour

Modified sorghum porridge, labeled flour

Experimental group

Description:

Modified sorghum porridge with 13C-labeled sorghum flour

Treatment:

Other: Modified sorghum porridge, labeled flour

Thinned sorghum porridge, labeled flour

Experimental group

Description:

Modified thinned sorghum porridge with 13C-labeled sorghum flour

Treatment:

Other: Thinned sorghum porridge, labeled flour

Modified sorghum porridge, octanoic acid

Experimental group

Description:

Modified sorghum porridge with 13C-labeled octanoic acid

Treatment:

Other: Modified sorghum porridge, octanoic acid