An interventional study of Normal sorghum porridge, algal starch and Normal sorghum porridge, algal dextrins in Malnutrition, Child, sponsored by Purdue University. Completed. Open to participants aged 18 Months to 30 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-16.
Sponsored by Purdue University · Not applicable, Interventional, and Other
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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.
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.
168 studies on the registry are indexed under Child Nutrition Disorders; 35 are open to participants now.
This study's enrollment of 54 is below the median of 400 across 133 interventional studies indexed under Child Nutrition Disorders.
Browse Child Nutrition Disorders studies →Purdue University is the lead sponsor of 175 studies on the registry; 21 are open to participants now.
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Exclusion Criteria:
Sorghum porridge with 13C-algal starch
Other: Normal sorghum porridge, algal starch
Sorghum porridge with 13C-algal starch limit dextrins
Other: Normal sorghum porridge, algal dextrins
Sorghum porridge with 13C-labeled sorghum flour
Other: Normal sorghum porridge, labeled flour
Modified sorghum porridge with 13C-labeled sorghum flour
Other: Modified sorghum porridge, labeled flour
Modified thinned sorghum porridge with 13C-labeled sorghum flour
Other: Thinned sorghum porridge, labeled flour
Modified sorghum porridge with 13C-labeled octanoic acid
Other: Modified sorghum porridge, octanoic acid
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 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 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 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 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 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.
Alpha-amylase sufficiency in children
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
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
Time frame: 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
Time frame: 3 hours after being fed test meal
No study locations are listed for this record.
Plan to share: No — Not shared
No publications or documents are linked to this record.
Ran from Dec 2012 to primary completion in Dec 2014, 24 months.
Of 82 non-industry interventional studies with no phase under Child Nutrition Disorders, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 35. This study's 24 months is above that.
Counting every sponsor, half of 85 studies reached it within 19 months; a quarter within 11 and three quarters within 36.
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This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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