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Changes of Plasma Amino Acid Profiles in Infants With a Nutrient-Fortified Complementary Food Supplement: Evidence From a 12-Month Single-Blind Cluster-Randomized Controlled Trial

ABSTRACT: Stunting is reportedly associated with low circulating levels of essential amino acids (EAAs). This study examined the effect of a macronutrient- and micronutrient-fortified complementary food supplement (KOKO Plus) on specific plasma EAA levels and stunting in infants aged 6–18 months. In a single-blind cluster-randomized controlled trial conducted in Ghana, infants were enrolled at 6 months and followed until 18 months. Thirty-eight communities were randomly assigned to receive KOKO Plus (KP, fourteen communities, n = 321), multiple-micronutrient powder (MN, thirteen communities, n = 327), or only nutritional education as control group (NE, eleven communities, n = 318), and all groups received nutrition education. Plasma amino acids (AAs) were measured at 6, 12, and 18 months (end point). Mixed-effects models were used to assess the effect of the intervention on plasma AAs, and the relationship between plasma branched-chain AAs (BCAAs) and the risk of stunting was assessed. At the end point, total BCAA concentrations (±standard error) significantly exceeded baseline in the KP (284.2 ± 4.3 μM) and NE (289.1 ± 4.4 μM) groups but not the MN group (264.4 ± 4.1 μM). After adjustment for compliance at 200 sachets, plasma BCAAs exceeded in the KP group (284.5 ± 4.2 μM) compared to the MN group (264.6 ± 4 μM). Plasma BCAAs were positively correlated with changes in length-for-age Z-score from baseline (R = 0.327, p = 0.048). In conclusion, the plasma BCAA concentrations of infants that received KP and the NE group was significantly higher compared to the MN group but there were no differences between the KP and NE group at end point. Improved plasma BCAAs may be due to improved nutrient intake by infants exposed to KP or NE. Low BCAAs were associated with stunting, replicating the previous finding. Clinical Trial Registration:https://clinicaltrials.gov/ct2/show/NCT03181178?term=NCT03181178&draw=2&rank=1, identifier: NCT03181178.

SUBMITTER: Furuta C

PROVIDER: S-EPMC8514778 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Iron deficiency (ID) and malaria co-exist in tropical regions and both contribute to high rates of anaemia in young children. It is unclear whether iron fortification combined with intermittent preventive treatment (IPT) of malaria would be an efficacious strategy for reducing anaemia in young children.A 9-month cluster-randomised, single-blinded, placebo-controlled intervention trial was carried out in children aged 12-36 months in south-central Côte d'Ivoire, an area of intense and perennial malaria transmission. The study groups were: group 1: normal diet and IPT-placebo (n = 125); group 2: consumption of porridge, an iron-fortified complementary food (CF) with optimised composition providing 2 mg iron as NaFeEDTA and 3.8 mg iron as ferrous fumarate 6 days per week (CF-FeFum) and IPT-placebo (n = 126); group 3: IPT of malaria at 3-month intervals, using sulfadoxine-pyrimethamine and amodiaquine and no dietary intervention (n = 127); group 4: both CF-FeFum and IPT (n = 124); and group 5: consumption of porridge, an iron-fortified CF with the composition currently on the Ivorian market providing 2 mg iron as NaFeEDTA and 3.8 mg iron as ferric pyrophosphate 6 days per week (CF-FePP) and IPT-placebo (n = 127). The primary outcome was haemoglobin (Hb) concentration. Linear and logistic regression mixed-effect models were used for the comparison of the five study groups, and a 2 × 2 factorial analysis was used to assess treatment interactions of CF-FeFum and IPT (study groups 1-4).After 9 months, the Hb concentration increased in all groups to a similar extent with no statistically significant difference between groups. In the 2 × 2 factorial analysis after 9 months, no treatment interaction was found on Hb (P = 0.89). The adjusted differences in Hb were 0.24 g/dl (95 % CI -0.10 to 0.59; P = 0.16) in children receiving IPT and -0.08 g/dl (95 % CI -0.42 to 0.26; P = 0.65) in children receiving CF-FeFum. At baseline, anaemia (Hb <11.0 g/dl) was 82.1 %. After 9 months, IPT decreased the odds of anaemia (odds ratio [OR], 0.46 [95 % CI 0.23-0.91]; P = 0.023), whereas iron-fortified CF did not (OR, 0.85 [95 % CI 0.43-1.68]; P = 0.68), although ID (plasma ferritin <30 ?g/l) was decreased markedly in children receiving iron fortified CF (OR, 0.19 [95 % CI 0.09-0.40]; P < 0.001).IPT alone only modestly decreased anaemia, but neither IPT nor iron fortified CF significantly improved Hb concentration after 9 months. Additionally, IPT did not augment the effect of the iron fortified CF. CF fortified with highly bioavailable iron improved iron status but not Hb concentration, despite three-monthly IPT of malaria. Thus, further research is necessary to develop effective combination strategies to prevent and treat anaemia in malaria endemic regions.http://www.clinicaltrials.gov ; identifier NCT01634945; registered on July 3, 2012.

Dataset Information

Changes of Plasma Amino Acid Profiles in Infants With a Nutrient-Fortified Complementary Food Supplement: Evidence From a 12-Month Single-Blind Cluster-Randomized Controlled Trial

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