Assessment of Starch Digestibility and Amylase Sufficiency in Children
Primary Purpose
Malnutrition, Child
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Normal sorghum porridge, algal starch
Normal sorghum porridge, algal dextrins
Normal sorghum porridge, labeled flour
Modified sorghum porridge, labeled flour
Thinned sorghum porridge, labeled flour
Modified sorghum porridge, octanoic acid
Sponsored by
About this trial
This is an interventional other trial for Malnutrition, Child
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Normal sorghum porridge, algal starch
Normal sorghum porridge, algal dextrins
Normal sorghum porridge, labeled flour
Modified sorghum porridge, labeled flour
Thinned sorghum porridge, labeled flour
Modified sorghum porridge, octanoic acid
Arm Description
Sorghum porridge with 13C-algal starch
Sorghum porridge with 13C-algal starch limit dextrins
Sorghum porridge with 13C-labeled sorghum flour
Modified sorghum porridge with 13C-labeled sorghum flour
Modified thinned sorghum porridge with 13C-labeled sorghum flour
Modified sorghum porridge with 13C-labeled octanoic acid
Outcomes
Primary Outcome Measures
Alpha-amylase sufficiency in children
Breath test using 13C-tracer was used to assess alpha-amylase sufficiency in healthy and moderately malnourished children
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
Gastric emptying
Breath test using 13C-tracer in octanoic acid was used to assess gastric emptying in healthy and moderately malnourished children
Secondary Outcome Measures
Full Information
NCT ID
NCT03467737
First Posted
March 10, 2018
Last Updated
March 10, 2018
Sponsor
Purdue University
Collaborators
Baylor College of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03467737
Brief Title
Assessment of Starch Digestibility and Amylase Sufficiency in Children
Official Title
Assessing Malian and U.S. Children for Starch Digestion and Amylase Sufficiency and Identifying Better Energy Providing Foods for Growth and Recovery
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
December 1, 2012 (Actual)
Primary Completion Date
December 31, 2014 (Actual)
Study Completion Date
July 1, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Purdue University
Collaborators
Baylor College of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition, Child
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Normal sorghum porridge, algal starch
Arm Type
Experimental
Arm Description
Sorghum porridge with 13C-algal starch
Arm Title
Normal sorghum porridge, algal dextrins
Arm Type
Experimental
Arm Description
Sorghum porridge with 13C-algal starch limit dextrins
Arm Title
Normal sorghum porridge, labeled flour
Arm Type
Experimental
Arm Description
Sorghum porridge with 13C-labeled sorghum flour
Arm Title
Modified sorghum porridge, labeled flour
Arm Type
Experimental
Arm Description
Modified sorghum porridge with 13C-labeled sorghum flour
Arm Title
Thinned sorghum porridge, labeled flour
Arm Type
Experimental
Arm Description
Modified thinned sorghum porridge with 13C-labeled sorghum flour
Arm Title
Modified sorghum porridge, octanoic acid
Arm Type
Experimental
Arm Description
Modified sorghum porridge with 13C-labeled octanoic acid
Intervention Type
Other
Intervention Name(s)
Normal sorghum porridge, algal starch
Intervention Description
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
Intervention Name(s)
Normal sorghum porridge, algal dextrins
Intervention Description
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
Intervention Name(s)
Normal sorghum porridge, labeled flour
Intervention Description
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
Intervention Name(s)
Modified sorghum porridge, labeled flour
Intervention Description
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
Intervention Name(s)
Thinned sorghum porridge, labeled flour
Intervention Description
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
Intervention Name(s)
Modified sorghum porridge, octanoic acid
Intervention Description
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 Outcome Measure Information:
Title
Alpha-amylase sufficiency in children
Description
Breath test using 13C-tracer was used to assess alpha-amylase sufficiency in healthy and moderately malnourished children
Time Frame
3 hours after being fed test meal
Title
Starch digestibility
Description
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
Time Frame
3 hours after being fed test meal
Title
Gastric emptying
Description
Breath test using 13C-tracer in octanoic acid was used to assess gastric emptying in healthy and moderately malnourished children
Time Frame
3 hours after being fed test meal
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
30 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Not shared
Learn more about this trial
Assessment of Starch Digestibility and Amylase Sufficiency in Children
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