Milk Matters in Malnutrition, is it the Lactose or Dairy Protein?

Malnutrition, Child Clinical Trial

Official title:

Milk Matters in Malnutrition, is it the Lactose or Dairy Protein?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04216043
• Other study ID #: 201912091
• Status: Completed
• Phase: N/A
• Start date: September 16, 2020
• Est. completion date: March 7, 2022

Study information

• Verified date: January 2024
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1102
• Est. completion date: March 7, 2022
• Est. primary completion date: March 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 59 Months

Eligibility

Inclusion Criteria:

• MUAC < 12.5 cm and = 11.5 cm without bipedal oedema

Exclusion Criteria:

• If they are involved in another research trial

• in another supplemental feeding program

• debilitating illness

• history of peanut or milk allergy

Related Conditions & MeSH terms

• Child Nutrition Disorders
• Malnutrition
• Malnutrition, Child

Intervention

Dietary Supplement:
• RUSF skimmed milk powder
ready-to-use supplementary foods 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients
• RUSF milk protein concentrate and sucrose
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
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
ready-to-use supplementary foods 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients

Locations

Country	Name	City	State
Sierra Leone	Project Peanut Butter Factory	Freetown

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Project Peanut Butter, Sierra Leone

Country where clinical trial is conducted

Sierra Leone, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Shankar AH. Nutritional modulation of malaria morbidity and mortality. J Infect Dis. 2000 Sep;182 Suppl 1:S37-53. doi: 10.1086/315906. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% 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
Primary	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
Secondary	Rate of weight gain (g/kg/d)	Changes in weight relative to baseline weight	up to 12 weeks of treatment
Secondary	Rate of length gain (mm/week)	Changes in linear growth	up to 12 weeks of treatment
Secondary	Final mid-upper arm circumference	Use the mid-upper are circumference at the visit when outcome was reached	up to 12 weeks of treatment
Secondary	Proportion with %L < 0.20	Percentage of children with %L excreted < 0.20	4 weeks
Secondary	16S rRNA beta-diversity at week 4	Looking at the 16S configuration in stool samples collected	4 weeks
Secondary	16S rRNA alpha-diversity at week 4	Several metrics of alpha diversity will be assessed, including Shannon's index	4 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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