Intérêt d’une nouvelle préparation infantile dans la prise en charge des régurgitations du nourrisson

Chevallier, Bertrand; Fournier, Véronique; Logre, B.; Beck, Lise; Ceccato, F; Hoa, Gaston Hui Bon; Lachambre, E.; Egroo, L. D. Van; Sznajder, M.

doi:10.1016/j.arcped.2009.01.001

Cited by 13 publications

(10 citation statements)

References 26 publications

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“…Of the remaining references, six referred to human (Carnielli et al, 1996;Kennedy et al, 1999;Miró et al, 2001;Bongers et al, 2007;Chevallier et al, 2009) and animal (Enzymotec, unpublished) intervention studies conducted with beta-palmitate and which report on stool consistency, whereas four human studies (Quinlan et al, 1995;Carnielli et al, 1995;Lucas et al, 1997;Lopez-Lopez et al, 2001) and five non-human studies (de Fouw et al, 1994;Sanders at al., 2001) addressed the mechanisms by which beta-palmitate could exert the claimed effect.…”

Section: Scientific Substantiation Of the Claimed Effectmentioning

confidence: 99%

“…One study was a single-arm intervention with no control group (Chevallier et al, 2009); the composition of the control formula was not specified in another study (Miró et al, 2001, unpublished); and in a third study (Bongers et al, 2007) the intervention and control formulas did not differ only in their beta-palmitate content, but also in the content of other ingredients (e.g. galacto-oligosaccharides and long-chain fructo-oligosaccharides), which may have an effect on stool consistency.…”

Section: Studies On Stool Consistencymentioning

confidence: 99%

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Scientific Opinion on the substantiation of a health claim related to beta‐palmitate and contribution to softening of stools pursuant to Article 14 of Regulation (EC) No 1924/2006

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Following an application from Specialised Nutrition Europe (formerly IDACE), submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924No /2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to beta-palmitate and contribution to softening of stools. The food constituent, beta-palmitate, that is the subject of the health claim, is sufficiently characterised. Contribution to softening of stools is a beneficial physiological effect for infants. In weighing the evidence the Panel took into account that, out of two human intervention studies with important methodological limitations, one suggested a stool-softening effect of beta-palmitate whereas the second did not, that one animal study did not support a stool-softening effect of beta-palmitate, and that the evidence provided for a mechanism by which beta-palmitate could contribute to the softening of stools is weak. The Panel concludes that a cause and effect relationship has not been established between the consumption of beta-palmitate and softening of stools. was asked to deliver an opinion on the scientific substantiation of a health claim related to beta-palmitate and contribution to softening of stools. © EuropeanThe scope of the application was proposed to fall under a health claim referring to children's development and health.The food constituent that is the subject of the health claim is beta-palmitate, a structured triglyceride with ≥ 50 % of palmitic acid at the sn-2 (middle or beta) position of the glycerol backbone. The intended use of beta-palmitate is to partially replace conventional triglycerides from vegetable oils in infant formulae to the extent that at least 35 % of the total palmitic acid content, which is assumed to be 20-25 % of total fatty acids, is in the sn-2 position. The Panel considers that beta-palmitate is sufficiently characterised.The claimed effect proposed by the applicant is "contributes to soften the stools, which helps to increase their frequency". The target population proposed by the applicant is infants (from birth to 12 months of age). Upon a request by EFSA for clarification on the claimed effect, the applicant indicated that the claimed effect referred to stool consistency rather than to stool frequency. Contribution to softening of stools is a beneficial physiological effect for infants.Eighteen publications were identified by the applicant and one by the Panel as being pertinent to the claim. Of these, three human studies and four non-human studies did not report on stool outcomes, and three human studies did not provide information about the effect of beta-palmitate on stool consistency. The Panel considers that no conclusions could be drawn from these publications for the scientific substantiation of the claim.Three human studies reported on the effects of beta-palmitate on stool consistency. In one study, stool consistency...

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Section: Scientific Substantiation Of the Claimed Effectmentioning

confidence: 99%

Section: Studies On Stool Consistencymentioning

confidence: 99%

Scientific Opinion on the substantiation of a health claim related to beta‐palmitate and contribution to softening of stools pursuant to Article 14 of Regulation (EC) No 1924/2006

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“…Other components such as kind of protein source, intact of hydrolysed prebiotics, or probiotics may also influence the clinical effect. Evidence from literature shows that thickened formula decreases regurgitation and infant distress caused by GOR [38,39]. Data suggest that improvement occurs with a couple of days [38][39][40].…”

mentioning

confidence: 99%

“…Evidence from literature shows that thickened formula decreases regurgitation and infant distress caused by GOR [38,39]. Data suggest that improvement occurs with a couple of days [38][39][40]. In case of failure, (non-IgE-mediated) cow's milk protein allergy should be considered [2], and management should be adapted accordingly.…”

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confidence: 99%

Prescription of acid inhibitors in infants: an addiction hard to break

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“…calcium absorption) (Chevallier et al, 2009;Innis et al, 1994;Nelson and Innis, 1999;Quinlan et al, 1995). Lopez-Lopez et al (2001) investigated faecal calcium, magnesium and fatty acid composition in healthy term infants, but did not assess calcium absorption.…”

Section: Scientific Substantiation Of the Claimed Effectmentioning

confidence: 99%

Scientific Opinion on the substantiation of a health claim related to beta‐palmitate and increased calcium absorption pursuant to Article 14 of Regulation (EC) No 1924/2006

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Following an application from IDACE, submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of France, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to beta‐palmitate and increased calcium absorption. The scope of the application was proposed to fall under a health claim referring to children's development and health. The food constituent that is the subject of the health claim is beta‐palmitate, a structured triglyceride with a high content of palmitic acid at the sn‐2 (middle or beta) position of the glycerol backbone. Beta‐palmitate is considered to be sufficiently characterised. The claimed effect is “beta palmitate enrichment contributes to increase calcium absorption”. The target population proposed by the applicant is infants from birth to 12 months of age, including healthy infants consuming follow‐on formula, preterm infants and infants needing foods for particular nutritional uses including foods for special medical purposes. The Panel considers that an increase in calcium absorption might be a beneficial physiological effect. In weighing the evidence, the Panel took into account the biological plausibility of the mechanism by which beta‐palmitate could exert the claimed effect and that three small human intervention studies in preterm and term infants provided some evidence that a higher degree of palmitic acid in the sn‐2 position of formula triglycerides may increase calcium absorption by decreasing faecal calcium excretion as calcium soaps, albeit a significant effect on calcium absorption was demonstrated in one study only. The Panel concludes that the evidence provided is insufficient to establish a cause and effect relationship between the consumption of beta‐palmitate and an increase in calcium absorption.

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Intérêt d’une nouvelle préparation infantile dans la prise en charge des régurgitations du nourrisson

Cited by 13 publications

References 26 publications

Scientific Opinion on the substantiation of a health claim related to beta‐palmitate and contribution to softening of stools pursuant to Article 14 of Regulation (EC) No 1924/2006

Scientific Opinion on the substantiation of a health claim related to beta‐palmitate and contribution to softening of stools pursuant to Article 14 of Regulation (EC) No 1924/2006

Prescription of acid inhibitors in infants: an addiction hard to break

Scientific Opinion on the substantiation of a health claim related to beta‐palmitate and increased calcium absorption pursuant to Article 14 of Regulation (EC) No 1924/2006

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