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| Name | Class |
|---|---|
| Project Peanut Butter, Sierra Leone | UNKNOWN |
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This study is to look at the types of sugar and protein composition in the treatment of moderate acute malnutrition and its effects on gut health. The study will use 4 different types of ready to use supplementary foods to see which one if any has better recovery rate along with looking into the gut health. Children will be treated using one food for up to 12 weeks. A subset of about 400 will be tested for intestinal permeability using the dual sugar test.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RUSF skimmed milk powder | Experimental | RUSF will provide 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients. Caregivers will instruct caregivers to feed the supplement only to the enrolled child, to feed it in addition to their usual diet, and to use daily portions. |
|
| RUSF milk protein concentrate and sucrose | Experimental | RUSF will provide 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients. Caregivers will instruct caregivers to feed the supplement only to the enrolled child, to feed it in addition to their usual diet, and to use daily portions. |
|
| RUSF soy protein and whey permeate | Experimental | RUSF will provide 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients. Caregivers will instruct caregivers to feed the supplement only to the enrolled child, to feed it in addition to their usual diet, and to use daily portions. |
|
| RUSF soy and sucrose | Experimental | RUSF will provide 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients. Caregivers will instruct caregivers to feed the supplement only to the enrolled child, to feed it in addition to their usual diet, and to use daily portions. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RUSF skimmed milk powder | Dietary Supplement | ready-to-use supplementary foods 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients |
|
| Measure | Description | Time Frame |
|---|---|---|
| % lactulose excretion after 4 weeks of supplementary feeding | This will only be assessed in children with higher-risk (MUAC < 12 cm) MAM at baseline. %L measured in the urine relative to the amount ingested will be calculated. %L will be categorized as normal (<0.2%) and abnormal (>0.2) | 4 weeks |
| 16S rRNA relative abundance of bacterial taxa after 4 weeks of supplementary feeding | This will only be assessed in children with higher-risk (MUAC < 12 cm) MAM at baseline | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of weight gain (g/kg/d) | Changes in weight relative to baseline weight | up to 12 weeks of treatment |
| Rate of length gain (mm/week) | Changes in linear growth |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Manary, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Project Peanut Butter Factory | Freetown | Sierra Leone |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18207566 | Background | Black RE, Allen LH, Bhutta ZA, Caulfield LE, de Onis M, Ezzati M, Mathers C, Rivera J; Maternal and Child Undernutrition Study Group. Maternal and child undernutrition: global and regional exposures and health consequences. Lancet. 2008 Jan 19;371(9608):243-60. doi: 10.1016/S0140-6736(07)61690-0. No abstract available. | |
| 15213048 |
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| ID | Term |
|---|---|
| D015362 | Child Nutrition Disorders |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D013395 | Sucrose |
| ID | Term |
|---|---|
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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The RUSF food products are very similar in appearance and texture; thus, subjects and caretakers will be blinded. The investigators making the clinical assessments will not have information as to specialized food product assignment of the subject, and will remain blinded.
| RUSF milk protein concentrate and sucrose | Dietary Supplement | ready-to-use supplementary foods 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients |
|
| RUSF soy protein and whey permeate | Dietary Supplement | ready-to-use supplementary foods 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients |
|
| RUSF soy and sucrose | Dietary Supplement | ready-to-use supplementary foods 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients |
|
| up to 12 weeks of treatment |
| Final mid-upper arm circumference | Use the mid-upper are circumference at the visit when outcome was reached | up to 12 weeks of treatment |
| Proportion with %L < 0.20 | Percentage of children with %L excreted < 0.20 | 4 weeks |
| 16S rRNA beta-diversity at week 4 | Looking at the 16S configuration in stool samples collected | 4 weeks |
| 16S rRNA alpha-diversity at week 4 | Several metrics of alpha diversity will be assessed, including Shannon's index | 4 weeks |
| Rate of recovery from moderate acute malnutrition | Recovery is when a participant reaches a Mid-Upper Arm Circumference of 12.5cm or better | up to 12 weeks of treatment |
| Rate of deteriorating to severe acute malnutrition or death | Severe acute malnutrition defined by MUAC < 11.5 cm or development of nutritional edema | up to 12 weeks of treatment |
| Sub-group analysis of %L and 16S rRNA outcomes among children not receiving breastfeeding at baseline vs. those being breastfeed at baseline | Anthropometric, %L and 16s rRNA outcomes (relative abundance, alpha-diversity, beta-diversity) will be compared between study foods among those who are reported to be breastfeeding vs. those who are not | 4 weeks |
| Sub-group analysis of anthropometric outcomes among children with MUAC < 12 cm vs. >= 12 cm at baseline | Rate of weight change, length change, final MUAC, recovery, SAM, and death will be compared between the study foods among children with baseline MUAC < vs. >=12 cm. | up to 12 weeks of treatment |
| Metabolomic feature abundance in the 4 dietary groups | Metabolomic feature abundance in the 4 dietary groups, as determined by untargeted metabolomics in 200 randomly selected children with MUAC < 12.1 cm on enrollment | After 4 weeks of supplementary feeding |
| Caulfield LE, de Onis M, Blossner M, Black RE. Undernutrition as an underlying cause of child deaths associated with diarrhea, pneumonia, malaria, and measles. Am J Clin Nutr. 2004 Jul;80(1):193-8. doi: 10.1093/ajcn/80.1.193. |
| 10944483 | Background | Shankar AH. Nutritional modulation of malaria morbidity and mortality. J Infect Dis. 2000 Sep;182 Suppl 1:S37-53. doi: 10.1086/315906. |
| 19225128 | Background | Matilsky DK, Maleta K, Castleman T, Manary MJ. Supplementary feeding with fortified spreads results in higher recovery rates than with a corn/soy blend in moderately wasted children. J Nutr. 2009 Apr;139(4):773-8. doi: 10.3945/jn.108.104018. Epub 2009 Feb 18. |
| 20332221 | Background | Nackers F, Broillet F, Oumarou D, Djibo A, Gaboulaud V, Guerin PJ, Rusch B, Grais RF, Captier V. Effectiveness of ready-to-use therapeutic food compared to a corn/soy-blend-based pre-mix for the treatment of childhood moderate acute malnutrition in Niger. J Trop Pediatr. 2010 Dec;56(6):407-13. doi: 10.1093/tropej/fmq019. Epub 2010 Mar 23. |
| 39307188 | Derived | Son M, Laury ML, Stephenson KB, May T, Hendrixson DT, Koroma AS, Ngegbai AS, Song JH, Naskidashvili N, Goo YA, Manary MJ. The Impact of Milk on Gut Permeability, Fecal 16S rRNA Gene Microbiota Profiling, and Fecal Metabolomics in Children with Moderate Malnutrition in Sierra Leone: A Double-Blind, Randomized Controlled Trial. Am J Clin Nutr. 2024 Nov;120(5):1114-1124. doi: 10.1016/j.ajcnut.2024.09.018. Epub 2024 Sep 21. |
| D000073893 |
| Sugars |