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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
Purdue University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Malnutrition, Child

Eligibility Criteria

18 Months - 30 Months (Child)All SexesAccepts 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

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

    First Posted
    March 10, 2018
    Last Updated
    March 10, 2018
    Sponsor
    Purdue University
    Collaborators
    Baylor College of Medicine
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    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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