The Role of Milk Protein and Whey Permeate in Lipid-based Nutrient Supplements on the Growth and Development of Stunted Children in Uganda: A Randomized Trial Protocol (MAGNUS)

Pesu, Hannah; Mutumba, Rolland; Mbabazi, Joseph; Olsen, Mette Frahm; Mølgaard, Christian; Michaelsen, Kim F.; Ritz, Christian; Filteau, Suzanne; Briend, André; Mupere, Ezekiel; Friis, Henrik; Grenov, Benedikte

doi:10.1093/cdn/nzab067

Cited by 9 publications

(8 citation statements)

References 48 publications

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“…Of those children enrolled in the study, 600 were randomized to one of the 4 formulations, based on MP or soy protein and WP or maltodextrin using a 2 × 2 factorial design. As a reference, a further 150 children were randomized to no supplement, allowing us to assess the effect of LNS, irrespective of dairy [ 20 ].…”

Section: Methodsmentioning

confidence: 99%

“…In our secondary analysis, we also compared the intervention, i.e., LNS irrespective of ingredient (600 participants) against the unsupplemented reference group (150 participants). We carried out prespecified subgroup analyses for breastfeeding status, sex, stunting severity, and inflammation (defined as serum AGP, a slow reacting acute phase reactant, >1.2 g/l) to test for any further interactions [ 20 ].…”

Section: Methodsmentioning

confidence: 99%

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Effect of milk protein and whey permeate in large quantity lipid-based nutrient supplement on linear growth and body composition among stunted children: A randomized 2 × 2 factorial trial in Uganda

et al. 2023

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Background Despite possible benefits for growth, milk is costly to include in foods for undernourished children. Furthermore, the relative effects of different milk components, milk protein (MP), and whey permeate (WP) are unclear. We aimed to assess the effects of MP and WP in lipid-based nutrient supplement (LNS), and of LNS itself, on linear growth and body composition among stunted children. Methods and findings We performed a randomized, double-blind, 2 × 2 factorial trial among 12 to 59 months old stunted children in Uganda. Children were randomized to 4 formulations of LNS with MP or soy protein isolate and WP or maltodextrin (100 g/day for 12 weeks) or no supplementation. Investigators and outcome assessors were blinded; however, participants were only blinded to the ingredients in LNS. Data were analyzed based on intention-to-treat (ITT) using linear mixed-effects models adjusted for age, sex, season, and site. Primary outcomes were change in height and knee-heel length, and secondary outcomes included body composition by bioimpedance analysis (ISRCTN13093195). Between February and September 2020, we enrolled 750 children with a median age of 30 (interquartile range 23 to 41) months, with mean (± standard deviation) height-for-age z-score (HAZ) −3.02 ± 0.74 and 12.7% (95) were breastfed. The 750 children were randomized to LNS (n = 600) with or without MP (n = 299 versus n = 301) and WP (n = 301 versus n = 299), or no supplementation (n = 150); 736 (98.1%), evenly distributed between groups, completed 12-week follow-up. Eleven serious adverse events occurred in 10 (1.3%) children, mainly hospitalization with malaria and anemia, all deemed unrelated to the intervention. Unsupplemented children had 0.06 (95% confidence interval, CI [0.02, 0.10]; p = 0.015) decline in HAZ, accompanied by 0.29 (95% CI [0.20, 0.39]; p < 0.001) kg/m2 increase in fat mass index (FMI), but 0.06 (95% CI [−0.002; 0.12]; p = 0.057) kg/m2 decline in fat-free mass index (FFMI). There were no interactions between MP and WP. The main effects of MP were 0.03 (95% CI [−0.10, 0.16]; p = 0.662) cm in height and 0.2 (95% CI [−0.3, 0.7]; p = 0.389) mm in knee-heel length. The main effects of WP were −0.08 (95% CI [−0.21, 0.05]; p = 220) cm and −0.2 (95% CI [−0.7; 0.3]; p = 403) mm, respectively. Interactions were found between WP and breastfeeding with respect to linear growth (p < 0.02), due to positive effects among breastfed and negative effects among non-breastfed children. Overall, LNS resulted in 0.56 (95% CI [0.42, 0.70]; p < 0.001) cm height increase, corresponding to 0.17 (95% CI [0.13, 0.21]; p < 0.001) HAZ increase, and 0.21 (95% CI [0.14, 0.28]; p < 0.001) kg weight increase, of which 76.5% (95% CI [61.9; 91.1]) was fat-free mass. Using height-adjusted indicators, LNS increased FFMI (0.07 kg/m2, 95% CI [0.0001; 0.13]; p = 0.049), but not FMI (0.01 kg/m2, 95% CI [−0.10, 0.12]; p = 0.800). Main limitations were lack of blinding of caregivers and short study duration. Conclusions Adding dairy to LNS has no additional effects on linear growth or body composition in stunted children aged 12 to 59 months. However, supplementation with LNS, irrespective of milk, supports linear catch-up growth and accretion of fat-free mass, but not fat mass. If left untreated, children already on a stunting trajectory gain fat at the expense of fat-free mass, thus nutrition programs to treat such children should be considered. Trial registration ISRCTN13093195

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Effect of milk protein and whey permeate in large quantity lipid-based nutrient supplement on linear growth and body composition among stunted children: A randomized 2 × 2 factorial trial in Uganda

et al. 2023

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“…This was a cross‐sectional study using baseline data collected between February and September 2020 as part of the MAGNUS trial (Hannah Pesu et al, 2021 ) (ISRCTN13093195). As previously described (Hannah Pesu et al, 2021 ; Mbabazi et al, 2023 ), the study was conducted at two public health centres in Walukuba division and Buwenge town council in Jinja district of East Central Uganda (Busoga sub region). The current cross‐sectional study nested within the RCT uses the maximum available sample at baseline of 750 children.…”

Section: Methodsmentioning

confidence: 99%

Correlates of early child development among children with stunting: A cross‐sectional study in Uganda

Mbabazi,

Pesu,

Mutumba

et al. 2024

Maternal & Child Nutrition

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Many children in low‐ and middle‐income countries are not attaining their developmental potential. Stunting is associated with poor child development, but it is not known which correlates of stunting are impairing child development. We explored potential socioeconomic, nutritional, clinical, and household correlates of early child development among 12–59‐month‐old children with stunting in a cross‐sectional study in Uganda. Development was assessed using the Malawi Development Assessment Tool (MDAT) across four domains of gross and fine motor, language, and social skills. Linear regression analysis was used to assess correlates of development in the four domains and total MDAT score. Of 750 children included, the median [interquartile range] age was 30 [23−41] months, 55% of the children resided in rural settings with 21% from female‐headed households and 47% of mothers had no schooling. The mean ± standard deviation height‐for‐age z‐score (HAZ) was −3.02 ± 0.74, 40% of the children had a positive malaria test and 65% were anaemic (haemoglobin < 110 g/L). One‐third had children's books at home, majority (96%) used household objects to play with and most of them (70%) used toys as pretence items like those to mimic cooking. After age, sex, and site adjustments, HAZ (0.24, 95% confidence interval [CI]: 0.14−0.33) and head circumference (0.07, 95% CI: 0.02−0.12) were positive correlates of total MDAT score, whereas weight‐for‐height z‐score (WHZ) was not. Current breastfeeding was associated with 0.41 (95% CI: 0.17−0.65) lower total MDAT score. Children from households with a single income earner had 0.22 (95% CI: 0.06−0.37) lower total MDAT score. Furthermore, severe food insecurity, inflammation and positive malaria test were associated with lower scores for motor development. All family care indicator subscales (FCIs) positively correlated with the total MDAT score and this association was independent of household's socioeconomic status. In conclusion, stunting degree, head circumference, number of household income earners and stimulation by improved FCIs correlate with early child development among stunted children. The negative association with prolonged breastfeeding is likely due to reverse causality. Identified correlates may inform initiatives to support children with stunting attain their development potential.

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“…This study reports secondary outcomes from the MAGNUS trial, a community-based randomized 2 × 2 factorial trial assessing the role of MP and WP in LNS on growth and development among stunted children (ISRCTN13093195). The primary outcome of the original trial was the effect of the intervention on height and knee-heel length as reported elsewhere [ 15 , 16 ]. The main outcome of the current study was child development.…”

Section: Methodsmentioning

confidence: 99%

“…As described previously [ 15 ], children were individually randomized to one of the four supplements (1:1:1:1) or to no supplementation (4:1). The study was block randomized with variable block sizes of 10 and 20, and stratified by site.…”

Section: Methodsmentioning

confidence: 99%

Effect of Milk Protein and Whey Permeate in Large-Quantity Lipid-Based Nutrient Supplement on Early Child Development among Children with Stunting: A Randomized 2 × 2 Factorial Trial in Uganda

et al. 2023

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Stunting affects 22% children globally, putting them at risk of adverse outcomes including delayed development. We investigated the effect of milk protein (MP) vs. soy and whey permeate (WP) vs. maltodextrin in large-quantity, lipid-based nutrient supplement (LNS), and LNS itself vs. no supplementation, on child development and head circumference among stunted children aged 1–5 years. We conducted a randomized, double-blind, community-based 2 × 2 factorial trial in Uganda (ISRCTN1309319). We randomized 600 children to one of four LNS formulations (~535 kcal/d), with or without MP (n = 299 vs. n = 301) or WP (n = 301 vs. n = 299), for 12 weeks or to no supplementation (n = 150). Child development was assessed using the Malawi Development Assessment Tool. Data were analyzed using linear mixed-effects models. Children had a median [interquartile range] age of 30 [23; 41] months and mean ± standard deviation height-for-age z-score of −3.02 ± 0.74. There were no interactions between MP and WP for any of the outcomes. There was no effect of either MP or WP on any developmental domain. Although LNS itself had no impact on development, it resulted in 0.07 (95%CI: 0.004; 0.14) cm higher head circumference. Neither dairy in LNS, nor LNS in itself, had an effect on development among already stunted children.

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The Role of Milk Protein and Whey Permeate in Lipid-based Nutrient Supplements on the Growth and Development of Stunted Children in Uganda: A Randomized Trial Protocol (MAGNUS)

Cited by 9 publications

References 48 publications

Effect of milk protein and whey permeate in large quantity lipid-based nutrient supplement on linear growth and body composition among stunted children: A randomized 2 × 2 factorial trial in Uganda

Effect of milk protein and whey permeate in large quantity lipid-based nutrient supplement on linear growth and body composition among stunted children: A randomized 2 × 2 factorial trial in Uganda

Correlates of early child development among children with stunting: A cross‐sectional study in Uganda

Effect of Milk Protein and Whey Permeate in Large-Quantity Lipid-Based Nutrient Supplement on Early Child Development among Children with Stunting: A Randomized 2 × 2 Factorial Trial in Uganda

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