Safety evaluation of a whey protein fraction containing a concentrated amount of naturally occurring TGF-β2

Forster, Roy; Bourtourault, M; Chung, Yunro; Silvano, Jérémy; Sire, Guillaume; Spézia, François; Puel, Caroline; Descotes, Jacques; Mikogami, Takashi

doi:10.1016/j.yrtph.2014.05.003

Cited by 5 publications

(6 citation statements)

References 24 publications

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“…A specific basic whey protein isolate (WPI) obtained using ion exchange chromatography from skimmed cow’s milk (Vitalarmor ® GF-100, Armor Protéines, Saint-Brice-en-Coglès, France) [29,30] was used as a source of cow’s-milk-derived TGF-β. The WPI was appropriately added or not to a partially hydrolyzed whey-based infant formula during the manufacturing process to obtain the TGF-β-enriched formula and the non-enriched formula (control formula, Nestlé, Konolfingen, Switzerland) containing 3 and 0 µg/L of TGF-β2, respectively.…”

Section: Methodsmentioning

confidence: 99%

Oral Tolerance Induction to Newly Introduced Allergen is Favored by a Transforming Growth Factor-β-Enriched Formula

et al. 2019

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Food allergies have become a major healthcare concern, hence preventive efforts to ensure oral tolerance induction to newly introduced antigens are particularly relevant. Given that transforming growth factor-β (TGF-β) plays a key role in immune tolerance, we tested whether an infant formula enriched with TGF-β would improve oral tolerance induction. A partially hydrolyzed whey protein-based formula was enriched with cow's-milk-derived TGF-β (TGF-β-enriched formula) by adding a specific whey protein isolate (WPI). The manufacturing process was optimized to achieve a concentration of TGF-β within the range of human breast milk concentrations. Protection from allergic sensitization and immune response was assessed in a mouse model. Adult mice received the TGF-β-enriched formula, a control non-enriched formula, or water ad libitum for 13 days before sensitization and suboptimal tolerization to ovalbumin (OVA). When compared to non-tolerized mice, suboptimally-tolerized mice supplemented with the TGF-β-enriched formula showed significantly lower levels of total immunoglobulin-E (IgE) and OVA-specific (IgG1). Mouse mast-cell protease-1 (mMCP-1) and cytokine levels were also significantly decreased in suboptimally-tolerized mice fed the TGF-β-enriched formula. In conclusion, oral supplementation with cow's-milk-derived TGF-β decreased allergic responses to newly introduced allergens and thus reduced the risk of developing food allergy.

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Section: Methodsmentioning

confidence: 99%

Oral Tolerance Induction to Newly Introduced Allergen is Favored by a Transforming Growth Factor-β-Enriched Formula

et al. 2019

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“…A cow milk-derived basic whey protein fraction containing naturally occurring TGF-b1 and TGF-b2 at a concentration of 7 and 150 lg/g powder, respectively (Vitalarmor â GF-100, Armor Prot eines, France) [24], was added to a partially hydrolysed whey protein-based formula to obtain a final concentration of approximately of 65 pg/mL TGF-b1 and 3 ng/mL TGF-b2. From weaning, pups were on standard animal chow (A04 diet, Safe, France) and this 'TGF-b-enriched formula' was administered 5 days a week ad libitum to the pups from weaning until 12 weeks of age; it was then replaced by water.…”

Section: Tgf-b-enriched Formula Administration After Weaningmentioning

confidence: 99%

Long‐term reduction in food allergy susceptibility in mice by combining breastfeeding‐induced tolerance and TGF‐β‐enriched formula after weaning

Rekima

Macchiaverni

Turfkruyer

et al. 2017

Clin Experimental Allergy

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“…Two bacterial reverse mutation tests were performed in Salmonella typhimurium strains TA98, TA100, TA102, TA1535 and TA1537 using the preincubation method and the plate incorporation method, in compliance with OECD TG 471 (Forster et al, 2014). Six concentrations of the NF were used for each bacterial strain: from 156.3 to 5,000 lg/plate using three plates per concentration with and without the presence of a metabolic activation system (S9 mix).…”

Section: Genotoxicitymentioning

confidence: 99%

“…The NF was also assessed in an in vitro mammalian cell micronucleus test with L5178Y TK+/À mouse lymphoma cells, in compliance with OECD 487 (Forster et al, 2014). Based on the results of the cytotoxicity measurements and the precipitation of the substance at high concentrations, doses for the main study were selected.…”

Section: Genotoxicitymentioning

confidence: 99%

“…A 6-week developmental toxicity study was performed with the NF in compliance with the USFDA Guidance for Industry, Nonclinical Safety Evaluation of Paediatric Drug Products (Forster et al, 2014). The objective of the study was to evaluate the potential effects of the NF on the development of juvenile rats, following daily oral (gavage) administration from post-natal day (PND) 7 to PND 49 inclusive.…”

Section: Reproductive and Developmental Toxicitymentioning

confidence: 99%

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Safety of Whey basic protein isolates as a novel food pursuant to Regulation (EU) 2015/2283

Turck¹,

Bresson²,

Burlingame³

et al. 2018

EFS2

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Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on whey basic protein isolate as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is obtained by ion exchange chromatography of skimmed cow's milk. The applicant intends to market the NF in infant and follow‐on formulae and meal replacement beverages, dietary foods for special medical purposes and as food supplements. The highest estimated intake of the NF based on the proposed uses and use levels would be 24.8 mg/kg body weight (bw) per day in infants and 27.8 in toddlers. The information provided on composition, specifications, production process and stability of the NF do not raise safety concerns. Taking into account the composition of the NF and the intended use levels, the Panel considers that the consumption of the NF is not nutritionally disadvantageous. The Panel considers that there is no concern with respect to genotoxicity. The no observed adverse effect level (NOAEL) of a subchronic 13‐week rat study was 2000 mg/kg bw per day. Considering the source, the production process and nature of the NF, the Panel considers the margin of exposure (MOE) of 154 to be sufficient for the adult population (on a high‐estimated intake of 13 mg/kg bw). For infants and toddlers, the MOE would be at least 81 and 72, respectively. Taking into account the composition of the NF, its source, the history of consumption of the main components of the NF, the production process and that the NOAEL in a subchronic rat study was the highest dose tested the Panel considers that also the MOE for infants and toddlers are sufficient. The Panel concludes that the novel food ingredient, whey basic protein isolate, is safe under the proposed uses and use levels.

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Safety evaluation of a whey protein fraction containing a concentrated amount of naturally occurring TGF-β2

Cited by 5 publications

References 24 publications

Oral Tolerance Induction to Newly Introduced Allergen is Favored by a Transforming Growth Factor-β-Enriched Formula

Oral Tolerance Induction to Newly Introduced Allergen is Favored by a Transforming Growth Factor-β-Enriched Formula

Long‐term reduction in food allergy susceptibility in mice by combining breastfeeding‐induced tolerance and TGF‐β‐enriched formula after weaning

Safety of Whey basic protein isolates as a novel food pursuant to Regulation (EU) 2015/2283

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