Assessment of Starch Digestibility and Amylase Sufficiency in Children

NCT03467737 | Completed

• 1 other identifier: 1209012695
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Malnutrition, Child

Outcome Measures

Primary Outcomes (3)

• Alpha-amylase sufficiency in children

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

  3 hours after being fed test meal

• Starch digestibility

  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 hours after being fed test meal

• Gastric emptying

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

  3 hours after being fed test meal

Study Arms (6)

Normal sorghum porridge, algal starch

EXPERIMENTAL

Sorghum porridge with 13C-algal starch

Other: Normal sorghum porridge, algal starch

Normal sorghum porridge, algal dextrins

EXPERIMENTAL

Sorghum porridge with 13C-algal starch limit dextrins

Other: Normal sorghum porridge, algal dextrins

Normal sorghum porridge, labeled flour

EXPERIMENTAL

Sorghum porridge with 13C-labeled sorghum flour

Other: Normal sorghum porridge, labeled flour

Modified sorghum porridge, labeled flour

EXPERIMENTAL

Modified sorghum porridge with 13C-labeled sorghum flour

Other: Modified sorghum porridge, labeled flour

Thinned sorghum porridge, labeled flour

EXPERIMENTAL

Modified thinned sorghum porridge with 13C-labeled sorghum flour

Other: Thinned sorghum porridge, labeled flour

Modified sorghum porridge, octanoic acid

EXPERIMENTAL

Modified sorghum porridge with 13C-labeled octanoic acid

Other: Modified sorghum porridge, octanoic acid

Interventions

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 starch

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, algal dextrins

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.

Normal sorghum porridge, labeled flour

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.

Modified sorghum porridge, labeled flour

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.

Thinned sorghum porridge, labeled flour

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.

Modified sorghum porridge, octanoic acid

Eligibility Criteria

• Age: 18 Months - 30 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Acutely ill and wasted child with weight for height lower than -2 z-score
• No medical problems other than their malnutrition status
• No medications

Sponsors & Collaborators

• Purdue University: lead
• Baylor College of Medicine: collaborator

MeSH Terms

Conditions

Child Nutrition Disorders

Interventions

octanoic acid

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 10, 2018
• First Posted: March 16, 2018
• Study Start: December 1, 2012
• Primary Completion: December 31, 2014
• Study Completion: July 1, 2016
• Last Updated: March 16, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share