Assessment of Starch Digestibility and Amylase Sufficiency in Children

NCT ID: NCT03467737

Last Updated: 2018-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-01
• Study Completion Date: 2016-07-01

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.

Conditions

Malnutrition, Child

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Normal sorghum porridge, algal starch

Sorghum porridge with 13C-algal starch

Group Type: EXPERIMENTAL

Normal sorghum porridge, algal starch

Intervention Type: 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

Sorghum porridge with 13C-algal starch limit dextrins

Group Type: EXPERIMENTAL

Normal sorghum porridge, algal dextrins

Intervention Type: 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

Sorghum porridge with 13C-labeled sorghum flour

Group Type: EXPERIMENTAL

Normal sorghum porridge, labeled flour

Intervention Type: 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

Modified sorghum porridge with 13C-labeled sorghum flour

Group Type: EXPERIMENTAL

Modified sorghum porridge, labeled flour

Intervention Type: 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

Modified thinned sorghum porridge with 13C-labeled sorghum flour

Group Type: EXPERIMENTAL

Thinned sorghum porridge, labeled flour

Intervention Type: 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

Modified sorghum porridge with 13C-labeled octanoic acid

Group Type: EXPERIMENTAL

Modified sorghum porridge, octanoic acid

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Months
• Maximum Eligible Age: 30 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Baylor College of Medicine

OTHER

Sponsor Role: collaborator

Purdue University

OTHER

Sponsor Role: lead

Responsible Party

Bruce R. Hamaker

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

1209012695

Identifier Type: -

Identifier Source: org_study_id