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Acceptability and efficacy of ready-to-use therapeutic food using soy protein isolate in under-5 children suffering from severe acute malnutrition in Bangladesh: a double-blind randomized non-inferiority trial

Abstract

Background and objective

Globally, around 20 million children suffer from severe acute malnutrition (SAM). Identifying a more economical treatment for those affected has the potential to make treatment more available and improve prognosis for recovery and future health.

Design/methods

The double-blind randomized study compared taste acceptability (measured by the eagerness to eat) and efficacy of soy-based RUTF (S-RUTF) with milk-based RUTF (M-RUTF) in 6- to 59-month-old children suffering from SAM (WHZ < −3) at icddr,b, in Bangladesh. These SAM children were enrolled in the study after completion of their stabilization phase of treatment. Tolerance of test-RUTF was also tested during the efficacy trial.

Results

The cross-over taste acceptability study, conducted in 36 children, revealed similar results between products and an absence of side effects. The efficacy trial enrolled 260 children (130, each group) with similar baseline characteristics, including mean ± SD age 15.0 ± 8.0 months, WHZ − 3.41 ± 0.40 and mid-upper arm circumference (MUAC) 11.1 ± 0.7 cm. The features at the end of study by RUTF group were (in S-RUTF vs. M-RUTF, respectively): total days from enrollment: 44 ± 34 versus 39 ± 30; weight gain (kg): 0.698 ± 0.438 versus 0.741 ± 0.381 and rate of weight gain (g/kg/d): 3.9 ± 3.2 versus 5.2 ± 4.6; MUAC gain (cm): 0.9 ± 0.7 versus 0.9 ± 0.6; and improvement of WHZ: 1.12 ± 0.82 versus 1.22 ± 0.68 (all data were man ± SD and none were significantly different between the groups). At enrollment and the end of intervention, the body composition [total body water (TBW): 70.3 ± 3.2 vs. 69.9 ± 3.5%, and fat: 11.0 ± 4.0 vs.11.5 ± 4.3% at baseline; and TBW: 65.5 ± 4.1 vs. 65.9 ± 4.6%; and fat: 16.8 ± 5.2 vs. 16.2 ± 5.8% in S-RUTF and M-RUTF group, respectively] was found similar. Moreover, the increment of total TBW, FM, and FFM was also observed similar between the groups.

Conclusions

This is the first randomized trial comparing S-RUTF using soy protein isolate with milk-based RUTF including comparison of body composition. S-RUTF was found equally acceptable as of milk-based RUTF without any adverse event. Children receiving S-RUTF showed similar pattern of changes in anthropometric indices, and body composition as of milk-based RUTF. Greater number of SAM children can be managed in the community with comparatively low-cost soy-based RUTF.

Trial registration

NCT01634009.

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Abbreviations

WHZ:

Weight-for-length or -height z-score

MUAC:

Mid-upper arm circumference

NNP:

National Nutrition Programme

SAM:

Severe acute malnutrition

HAZ:

Height-for-age z-score

CTC:

Community-based therapeutic care

CMAM:

Community-based management of acute malnutrition

RUTF:

Ready-to-use therapeutic food

M-RUTF:

Milk-based RUTF

Soy-RUTF:

Soy-based RUTF

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Acknowledgements

This research protocol was funded by United Soy Bean Board (USB), Grant Number 00735: USB Project: 1530-512-5221. icddr,b acknowledges with gratitude the commitment of USB to its research efforts. icddr,b is also grateful to the Governments of Bangladesh, Canada, Sweden and the UK for providing core/unrestricted support. We also acknowledge the help of DuPont Nutrition and Health for producing and masking the RUTFs for this trial.

Author information

Conceived and designed the study: MIH, TA; data check and analysis: MIH, SH, MMI; manuscript writing and revision: all

Correspondence to Md. Iqbal Hossain.

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Conflict of interest

None of the investigators has any affiliation with producer of neither product used in the study nor any financial interest that might be affected by the results of this study.

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Hossain, M.I., Huq, S., Islam, M.M. et al. Acceptability and efficacy of ready-to-use therapeutic food using soy protein isolate in under-5 children suffering from severe acute malnutrition in Bangladesh: a double-blind randomized non-inferiority trial. Eur J Nutr 59, 1149–1161 (2020). https://doi.org/10.1007/s00394-019-01975-w

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Keywords

  • Soy-based RUTF
  • Milk-based RUTF
  • Severe acute malnutrition
  • Under-5 children
  • Body composition