Malnutrition, ChildNCT03467737
Assessment of Starch Digestibility and Amylase Sufficiency in Children
A study testing Normal sorghum porridge, algal starch, Normal sorghum porridge, algal dextrins and Normal sorghum porridge, labeled flour in people with Malnutrition, Child, run by Purdue University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 monthsHealthy volunteers can take part
- Conditions the study is for
- Malnutrition, Child
- What is being tested?
- Normal sorghum porridge, algal starch, Normal sorghum porridge, algal dextrins and Normal sorghum porridge, labeled flour
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2012to 1 Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Acutely ill and wasted child with weight for height lower than -2 z-score
- No medical problems other than their malnutrition status
- No medications
About this study
Official title: Assessing Malian and U.S. Children for Starch Digestion and Amylase Sufficiency and Identifying Better Energy Providing Foods for Growth and Recovery
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.
Read the 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
- Being tested
- 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
- Medical subject headings
- Child Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal sorghum porridge, algal starchOther
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 dextrinsOther
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 flourOther
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 flourOther
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 flourOther
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 acidOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Normal sorghum porridge, algal starch | Experimental | Sorghum porridge with 13C-algal starch Receives: Other: Normal sorghum porridge, algal starch |
| Normal sorghum porridge, algal dextrins | Experimental | Sorghum porridge with 13C-algal starch limit dextrins Receives: Other: Normal sorghum porridge, algal dextrins |
| Normal sorghum porridge, labeled flour | Experimental | Sorghum porridge with 13C-labeled sorghum flour Receives: Other: Normal sorghum porridge, labeled flour |
| Modified sorghum porridge, labeled flour | Experimental | Modified sorghum porridge with 13C-labeled sorghum flour Receives: Other: Modified sorghum porridge, labeled flour |
| Thinned sorghum porridge, labeled flour | Experimental | Modified thinned sorghum porridge with 13C-labeled sorghum flour Receives: Other: Thinned sorghum porridge, labeled flour |
| Modified sorghum porridge, octanoic acid | Experimental | Modified sorghum porridge with 13C-labeled octanoic acid Receives: Other: Modified sorghum porridge, octanoic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alpha-amylase sufficiency in children
Breath test using 13C-tracer was used to assess alpha-amylase sufficiency in healthy and moderately malnourished children
Measured: 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
Measured: 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
Measured: 3 hours after being fed test meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2018
- Study start1 Dec 2012
- Primary completion31 Dec 2014
- Study completion1 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malnutrition, ChildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Collaborators
- Baylor College of Medicine
- Responsible party
- Principal investigator, Bruce R. Hamaker, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03467737
- Sponsor's protocol ID
- 1209012695
- Status last verified
- Mar 2018
- First submitted
- 10 Mar 2018
- Last updated
- 16 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not shared
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Malian and U.S. Children for Starch Digestion and Amylase Sufficiency and Identifying Better Energy Providing Foods for Growth and Recovery
- ClinicalTrials.gov ID
- NCT03467737
- Acronym / sponsor ID
- 1209012695
- Conditions
- Malnutrition, Child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Collaborators
- Baylor College of Medicine
- Study start
- 1 Dec 2012 (actual)
- Primary completion
- 31 Dec 2014 (actual)
- Study completion
- 1 Jul 2016 (actual)
- First posted
- 16 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Normal sorghum porridge, algal starch | Experimental | Other: Normal sorghum porridge, algal starchSorghum porridge with 13C-algal starch |
| Normal sorghum porridge, algal dextrins | Experimental | Other: Normal sorghum porridge, algal dextrinsSorghum porridge with 13C-algal starch limit dextrins |
| Normal sorghum porridge, labeled flour | Experimental | Other: Normal sorghum porridge, labeled flourSorghum porridge with 13C-labeled sorghum flour |
| Modified sorghum porridge, labeled flour | Experimental | Other: Modified sorghum porridge, labeled flourModified sorghum porridge with 13C-labeled sorghum flour |
| Thinned sorghum porridge, labeled flour | Experimental | Other: Thinned sorghum porridge, labeled flourModified thinned sorghum porridge with 13C-labeled sorghum flour |
| Modified sorghum porridge, octanoic acid | Experimental | Other: Modified sorghum porridge, octanoic acidModified sorghum porridge with 13C-labeled octanoic acid |
Who may qualify
- Ages
- 18 to 30 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Acutely ill and wasted child with weight for height lower than -2 z-score
- No medical problems other than their malnutrition status
- No medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal sorghum porridge, algal starchNormal 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. | Other | Normal sorghum porridge, algal starch |
| Normal sorghum porridge, algal dextrinsNormal 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. | Other | Normal sorghum porridge, algal dextrins |
| Normal sorghum porridge, labeled flourNormal sorghum porridge with a portion of 13C-labeled sorghum flour was fed, breath tested, for starch digestibility assessment in healthy and moderately malnourished children. | Other | Normal sorghum porridge, labeled flour |
| Modified sorghum porridge, labeled flourModified 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. | Other | Modified sorghum porridge, labeled flour |
| Thinned sorghum porridge, labeled flourThinned 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. | Other | Thinned sorghum porridge, labeled flour |
| Modified sorghum porridge, octanoic acidModified 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. | Other | Modified sorghum porridge, octanoic acid |
Primary outcome
Alpha-amylase sufficiency in children
Time frame: 3 hours after being fed test meal
Breath test using 13C-tracer was used to assess alpha-amylase sufficiency in healthy and moderately malnourished children
Starch digestibility
Time frame: 3 hours after being fed test meal
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
Time frame: 3 hours after being fed test meal
Breath test using 13C-tracer in octanoic acid was used to assess gastric emptying in healthy and moderately malnourished children
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2018.
- Individual participant dataSharing planned: No. Not shared
Related trials for Malnutrition, Child
Active, not recruitingPhase 2
Maternal Probiotic Intervention to Improve Gut Health-Trial II-Pakistan
Environmental Enteric Dysfunction (EED), Stunting
Recruiting
Role of Vitamin D Supplementation in Children With Irritable Bowel Syndrome
Irritable Bowel Syndrome (IBS), Vitamin D Deficiency
Active, not recruiting
Milk Fat Globule Membrane-Enhanced RUTF for Children With Severe Acute Malnutrition
Severe Acute Malnutrition, Cognitive Impairment
Active, not recruitingPhase 2
Comparative Efficacy of Antibiotics for Small Intestine Bacterial Overgrowth in Bangladeshi Children
Small Intestine Bacterial Overgrowth
Recruiting
Effectiveness of an Alternative Protocol in the Management of Acute Malnutrition
Acute Malnutrition With no Complications
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Normal sorghum porridge, algal starch, Normal sorghum porridge, algal dextrins and Normal sorghum porridge, labeled flour in people with Malnutrition, Child, run by Purdue University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alpha-amylase sufficiency in children (time frame: 3 hours after being fed test meal). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2018.