scholarly journals Assessment of Benefits and Risks of Probiotics in Processed Cerealbased Baby Foods Bifidobacterium Lactis Bb12

2021 ◽  
pp. 58-60
Author(s):  
Ragnhild Halvorsen ◽  
Judith Narvhus ◽  
Jørgen Lassen ◽  
Tore Midtvedt ◽  
Jarle Rugtveit ◽  
...  
Keyword(s):  
Small Intestine ◽  
Immune System ◽  
Food Safety ◽  
Health Effects ◽  
Age Groups ◽  
Daily Intake ◽  
Positive Health ◽  
Bifidobacterium Lactis ◽  
Small Children ◽  
Baby Foods

The Norwegian Scientific Committee for Food Safety (VKM) has appointed an ad hoc-group of experts to answer a request from the Norwegian Food Safety Authority regarding benefit and risk assessment of B. lactis Bb12 in baby foods focusing on the age groups 4-6 months, 612 months and 1-3 years. This assessment is based on the literature provided by the notifier as well as that found by a MEDLINE search.    An notification for use of processed cereal-based baby foods (from now on called cereals) intended for infants and small children supplemented with the microorganism Bifidobacterium lactis (B. lactis) Bb12 in Norway initiated this work.     Studies of potential hazards and positive health effects from cereals containing B. lactis Bb12 intended for infants and young children have not been reported in the available literature. However, reports on safety of and positive health effects from infant and follow on formula supplemented with B. lactis Bb12 are available and have been assessed by VKM. In most of these clinical studies B. lactis Bb12 was administered in combination with other probiotic strains.   Clinical studies report no serious adverse events of infant formula supplemented with B. lactis Bb12. The effect of long term daily consumption of such supplemented formula by the actual age groups is not known.   A few studies have demonstrated some effect of supplementing baby food with probiotics, including B. lactis Bb12, on diarrhoea and atopic eczema while other studies do not show such effects. Thus, the scientific evidence for a favourable effect of supplementing formula or solid food with B. lactis Bb12, is weak and in some cases lacking.    There are no studies demonstrating a positive effect of cereals supplemented with B. lactis Bb12 intended for infants and small children.   Several health claims related to probiotics have been assessed by EFSA, including claims on reduction of gastro-intestinal discomfort, normal functioning of the alimentary tract, building of the natural intestinal barrier, improvement of the general immunity, mental and cognitive developments of children and immune system of children during growth. In the opinions so far, EFSA has concluded that a cause and effect relationship has not been established between the consumption of the probiotic containing products and the claimed effect. None of the products assessed so far contained B. lactis Bb12 (1 November 2009).   Commercially produced cereals are frequent given to infants and small children in Norway from an early age and this is particularly important for the establishment of the intestinal bacterial flora and the development of the intestinal mucosal immune system. According to the notifier, one portion (25gram) of the cereal powder contains 1 x 109 B. lactis Bb12 in monoculture. Taking into consideration that the daily intake is often greater than one portion of cereals, even in infants below 6 months of age, this would represent a daily intake of 1-2 x 109 cfu B. lactis Bb12 for an infant 4-6 months and even more in infants above 6 months. If a considerable amount of the B. lactis Bb12 survives the transport to the small intestine, it would represent a dominating and monocultural supply, often several times a day, to the small intestine.  The immaturity and vulnerability of the intestinal microbiota and the immune system makes the two lowest age groups, 4 – 6 and 6 – 12 months, at the highest risk of unwanted health effects due to the daily intake of probiotics.  

scholarly journals Assessment of Benefits and Risks of Probiotics in Processed Cereal-based Baby Foods Lactobacillus Paracasei ssp. Paracasei F19

2021 ◽  
pp. 64-66
Author(s):  
Ragnhild Halvorsen ◽  
Jørgen Lassen ◽  
Tore Midtvedt ◽  
Judith Narvhus ◽  
Jarle Rugtveit ◽  
...  
Keyword(s):  
Food Safety ◽  
Health Effects ◽  
Bacterial Strain ◽  
Intestinal Flora ◽  
Lactobacillus Paracasei ◽  
Resistance Pattern ◽  
Age Group ◽  
Small Children ◽  
Genetic Expression ◽  
Baby Foods

The Norwegian Scientific Committee for Food Safety (VKM) has appointed an ad hoc-group of experts to answer a request from the Norwegian Food Safety Authority regarding benefit and risk assessment of Lactobacillus paracasei ssp. paracasei F19 (F19) in processed cerealbased baby foods intended for small children 1-3 years. This assessment is based on the literature provided by the notifier as well as that found by a MEDLINE search.    A notification regarding two products of processed cereal-based baby foods (hereafter called cereals), intended for small children and supplemented with the bacterium F19 initiated this work.   A daily supply of a monoculture of a particular bacterial strain in large quantities to an age group without a fully established intestinal flora, may have unknown adverse effects. There are however, to our knowledge, no studies investigating possible short or long term adverse health effects of F19 in processed cereal-based baby food given to children 13 months onwards.   The documentation and information provided by the notifier regarding the genetic stability of F19 in the two products during processing and storage, is considered insufficient and does not allow any conclusions to be drawn.    Moreover, the documentation obtained is not conclusive regarding the antibiotic resistance pattern of the bacterial strain used in the products in question, as the information on different antibiotics is partly inconsistent. The information about specific localization (chromosomal, plasmid) of the resistance genes is not sufficient.    Studies demonstrate that F19, as well as other bacterial strains considered probiotic, is able to “crosstalk” with enterocytes in mice and that the result of the “crosstalk” depends upon the microbiota present. Whether F19 has a similar “crosstalk-profile” in humans is unknown. However, as the strain is originally of human origin, it seems reasonable to assume that such “crosstalk” may occur. Thus, before giving F19 daily for months and years, it seems reasonable to ask for additional molecular and physiological studies to unravel the functional impact of possible changes in genetic expression in children.    Lactobacillus infections do occasionally occur, mainly as bacteremia, endocarditis and localized infections (e.g. abscesses, peritonitis, and meningitis) in patients with severe underlying diseases. Most of them are elderly, but children are not excluded. The species most often isolated are L. casei and L. rhamnosus, followed by L. paracasei.    The increasing use of immunosuppressive therapy and broad spectrum antibiotics which are ineffective against Lactobacillus, might increase the importance of these bacteria as possible pathogens. In order to be able to draw any conclusions regarding beneficial effects of F19, there is a need for randomized placebo-controlled studies in larger populations and in the relevant age group.    According to EFSA, Lactobacillus paracasei ssp. paracasei F19 is sufficiently characterized. The documentation provided is, however, not sufficient to claim positive health effects and thus F19 is not proven to be probiotic.    There are no published dose-response studies of F19 in children, neither regarding survival of F19 in the gastrointestinal tract, nor possible negative health effects. Thus the potential for negative health effects as e.g. spreading of antimicrobial resistance or unfavourable impact on the genetic expression in children related to the frequency and/or dose of a monoculture of F19 cannot be assessed.

scholarly journals Consumption of prebiotic inulin enriched with oligofructose in combination with the probiotics Lactobacillus rhamnosus and Bifidobacterium lactis has minor effects on selected immune parameters in polypectomised and colon cancer patients

2007 ◽  
Vol 97 (4) ◽  
pp. 676-684 ◽  
Author(s):  
Monika Roller ◽  
Yvonne Clune ◽  
Kevin Collins ◽  
Gerhard Rechkemmer ◽  
Bernhard Watzl
Keyword(s):  
Colon Cancer ◽  
Immune System ◽  
Cancer Patients ◽  
Transforming Growth Factor ◽  
Daily Intake ◽  
Lactobacillus Rhamnosus ◽  
Prostaglandin E ◽  
Bifidobacterium Lactis ◽  
Colony Forming Units ◽  
Ifn Γ

Probiotics (PRO) modulate immunity in humans, while the effect of prebiotics (PRE) and synbiotics (SYN) on the human immune system are not well studied yet. The objective of this study was to investigate whether daily intake of a SYN modulates immune functions. In a randomised double-blind, placebo-controlled trial, thirty-four colon cancer patients who had undergone ‘curative resection’ and forty polypectomised patients participated. Subjects of the SYN group daily received encapsulated bacteria (1 × 1010 colony-forming units of Lactobacillus rhamnosus GG (LGG) and 1 × 1010 colony-forming units of Bifidobacterium lactis Bb12 (Bb12)) and 10 g of inulin enriched with oligofructose. Controls received encapsulated maltodextrin and 10 g of maltodextrin. Prior to intervention (T1), and 6 (T2) and 12 weeks after the start of the intervention (T3), phagocytic and respiratory burst activity of neutrophils and monocytes, lytic activity of natural killer cells and production of interleukin (IL)-2, IL-10 and IL-12, as well as tumour necrosis factor-α and interferon-γ (IFN-γ) by activated peripheral blood mononuclear cells (PBMC) were measured. In faeces, the concentrations of transforming growth factor-β1 and prostaglandin E2 were measured. IL-2 secretion by activated PBMC from the polyp group increased significantly between T1 or T2 and T3 (P < 0·05). In the cancer group, SYN treatment resulted in an increased capacity of PBMC to produce IFN-γ at T3 (P < 0·05). Other immunity-related parameters were not affected by SYN treatment, neither in the cancer nor in the polyp group. In conclusion, supplementation with this SYN has minor stimulatory effects on the systemic immune system of the two study groups. Further studies in humans should aim to focus on the gut-associated immune system.

scholarly journals Risk Assessments of Aspartame, Acesulfame K, Sucralose and Benzoic Acid from Soft Drinks, “Saft”, Nectar and Flavoured Water

2020 ◽  
pp. 66-68
Author(s):  
Inger-Lise Steffensen ◽  
Jan Alexander ◽  
Mona-Lise Binderup ◽  
Ellen Merete Bruzell ◽  
Knut Helkås Dahl ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Food Safety ◽  
Benzoic Acid ◽  
Food Additives ◽  
Age Groups ◽  
Daily Intake ◽  
Average Concentration ◽  
Soft Drinks ◽  
The Other ◽  
Average Content

The Norwegian Scientific Committee for Food Safety (Vitenskapskomiteen for mattrygghet, VKM), Panel on Food Additives, Flavourings, Processing Aids, Materials in Contact with Food and Cosmetics, has at the request of the Norwegian Food Safety Authority (Mattilsynet) conducted a risk assessment of the intense sweeteners aspartame, acesulfame K and sucralose and the preservative benzoic acid from soft drinks, “saft”, nectar and flavoured water.  The risk assessment includes exposure assessments and the calculated exposures are compared to the acceptable daily intake (ADI) for the respective sweeteners and benzoic acid. VKM was also requested to compare the current calculated intake of aspartame, acesulfame K and benzoic acid to the calculated intake reported by VKM in 2007 (from the VKM report «Impact on health when sugar is replaced with intense sweeteners in soft drinks, «saft» and nectar») (VKM, 2007). Exposure calculations were made for four different scenarios with varying concentrations of added sweeteners (either the average concentration or the highest reported concentration for the respective sweetener) and varying consumption of beverages with sweeteners (either the actual reported consumption of beverages added sweetener or the assumption that all reported beverages were added sweeteners). Scenario 1 gives the best estimate of the current situation in the population (average content  of sweeteners/benzoic acid, actual reported consumption), scenarios 2-4 is based on one or both of the following assumptions: only beverages added sweeteners are consumed, the beverages consumed are added the highest reported value of the sweeteners (scenario 2: average content of sweeteners/benzoic acid, all consumed beverages contain sweeteners; scenario 3: highest reported content of sweeteners/benzoic acid, actual reported consumption; scenario 4: highest reported content of sweeteners/benzoic acid, all consumed beverages contain sweeteners).   In the current risk assessment, the intake of sweeteners and benzoic acid for two-year-old children and 18-70 year old men and women were calculated. Due to lack of new dietary surveys, the other age groups of children and adolescents were excluded. The estimated intake of aspartame, acesulfame K and sucralose was below the ADI for all age groups, both for mean and high consumers in all scenarios. When it comes to benzoic acid, the calculated mean and high intake for adults was below the ADI in all scenarios. The mean intake for 2year-olds was below ADI in all scenarios, as was the intake for high consumers among the 2year-olds in scenarios 1 and 2. However, high consumers among the two-year-old children in scenario 3 and 4 reached the ADI. Due to differences in the way the calculations were done in the current opinion and in 2007, it was not possible to compare the current calculated intake of aspartame, acesulfame K and benzoic acid to the calculated intakes reported by VKM in 2007. VKM concludes that for all age groups in all scenarios the intake of sweeteners is well below the established ADI values, thus, there is no concern related to the intake of the sweeteners aspartame, acesulfame K or sucralose. VKM further concludes that the benzoic acid intake in 2-year-old-children, in scenarios 3 and 4, is of concern as it reaches ADI for high consumers of soft drinks, “saft” and flavoured water, although the ADI is not a threshold for toxicity. For the other age groups, there is no concern related to the intake of benzoic acid from beverages. However, it should be noted that a considerable intake of benzoic acid also is expected from other sources such as food and cosmetics. High consumers of soft drinks, “saft” or flavoured water in all age groups could be at risk for approaching or exceeding ADI if the exposures from foods are taken into account. This is especially of concern for 2-year-old children, since high consumers of soft drinks and “saft” already have reached the ADI. 

Efficacy of one-dose intramuscular rabies vaccine as pre-exposure prophylaxis in travellers

2021 ◽  
Author(s):  
Deborah J Mills ◽  
Colleen L Lau ◽  
Christine Mills ◽  
Luis Furuya-Kanamori
Keyword(s):  
Immune System ◽  
Rapid Development ◽  
Age Groups ◽  
Rabies Vaccine ◽  
Post Exposure Prophylaxis ◽  
Post Intervention ◽  
Quasi Experimental ◽  
Alternative Schedule ◽  
Insufficient Time ◽  
Exposure Prophylaxis

Abstract Background Current guidelines for rabies pre-exposure prophylaxis (PrEP) recommend multiple vaccine doses. Travellers sometimes present for pre-travel consultation with insufficient time to complete standard PrEP schedules. We investigated the efficacy of one-dose intramuscular (IM) vaccine in priming the immune system (as PrEP) by measuring antibody response to simulated post-exposure prophylaxis (PEP). Methods A quasi-experimental pre–post intervention clinical trial was conducted at a specialist travel clinic in Australia. Adults (≥18 years) without a history of rabies vaccination were included. At Visit 1, seronegative status was confirmed and one dose of 0.5 ml IM rabies vaccine (Verorab®) administered. At Visit 2 (≥60 days after Visit 1), serology was repeated and a simulated PEP dose (0.5 ml IM) given on this day and again 3 days later (Visit 3). Serology was repeated at Visit 4 (7 days after Visit 2). Results A total of 94 antibody-negative participants were included (&lt;50 years [n = 50]; ≥50 years [n = 44]). At Visit 2, 38.0 and 31.8% of participants aged &lt;50 and ≥50 years were antibody-positive (≥0.5 EU/ml). At Visit 4, all participants were antibody-positive; 82.0 and 47.7% of participants aged &lt;50 and ≥50 years had antibody levels &gt;4 EU/ml, respectively. Conclusions One-dose IM vaccine was effective as PrEP for priming the immune system in both age groups, resulting in rapid development of antibodies 7 days after commencing simulated PEP. If there is insufficient time to complete a standard PrEP schedule, one-dose IM could be considered as an alternative schedule for short trips, rather than not offering travellers any doses at all. Clinical trials registration: ACTRN12619000946112.

scholarly journals Dietary supplementation with Bifidobacterium lactis NCC2818 from weaning reduces local immunoglobulin production in lymphoid-associated tissues but increases systemic antibodies in healthy neonates

2013 ◽  
Vol 110 (7) ◽  
pp. 1243-1252 ◽  
Author(s):  
Marie C. Lewis ◽  
Dilip V. Patel ◽  
Jenni Fowler ◽  
Swantje Duncker ◽  
Adrian W. Zuercher ◽  
...  
Keyword(s):  
Immune System ◽  
Health Benefit ◽  
Dietary Supplementation ◽  
Nutritional Intervention ◽  
Dietary Interventions ◽  
Probiotic Supplementation ◽  
Human Infants ◽  
Bifidobacterium Lactis ◽  
Beneficial Effects ◽  
Mucosal Tissues

Weaning is associated with a major shift in the microbial community of the intestine, and this instability may make it more acquiescent than the adult microbiota to long-term changes. Modulation achieved through dietary interventions may have potentially beneficial effects on the developing immune system, which is driven primarily by the microbiota. The specific aim of the present study was to determine whether immune development could be modified by dietary supplementation with the human probiotic Bifidobacterium lactis NCC2818 in a tractable model of weaning in infants. Piglets were reared by their mothers before being weaned onto a solid diet supplemented with B. lactis NCC2818, while sibling controls did not receive supplementation. Probiotic supplementation resulted in a reduction in IgA (P< 0·0005) and IgM (P< 0·009) production by mucosal tissues but had no effect on IgG production (P>0·05). Probiotic-supplemented pigs had more mast cells than unsupplemented littermates (P< 0·0001), although numbers in both groups were low. In addition, the supplemented piglets made stronger serum IgG responses to fed and injected antigens (P< 0·05). The present findings are consistent with B. lactis NCC2818 reducing intestinal permeability induced by weaning, and suggest that the piglet is a valuable intermediate between rodent models and human infants. The results also strongly suggest that measures of the effect of probiotic supplementation on the immune system need to be interpreted carefully as proxy measures of health benefit. However, they are useful in developing an understanding of the mechanism of action of probiotic strains, an important factor in predicting favourable health outcomes of nutritional intervention.

Evaluation of Two Tetravalent (ACYW135) Meningococcal Vaccines in Infants and Small Children: A Clinical Study Comparing Immunogenicity of O-Acetyl-Negative and O-Acetyl-Positive Group C Polysaccharides

PEDIATRICS ◽  
1985 ◽  
Vol 76 (1) ◽  
pp. 91-96
Author(s):  
Heikki Peltola ◽  
Assad Safary ◽  
Helena Käyhty ◽  
Viena Karanko ◽  
Francis E. André
Keyword(s):  
Clinical Study ◽  
Elevated Temperatures ◽  
Age Groups ◽  
Antibody Responses ◽  
Meningococcal Vaccine ◽  
Small Children ◽  
Positive Group ◽  
Systemic Reactions ◽  
Antibody Titers ◽  
Group A

Two different tetravalent polysaccharide vaccines against group A, C, Y, and W135 meningococci were given to 118 infants aged 6 to 23 months; the same vaccines were administered in a second dose 12 months later to those infants aged 6 to 11 months at first vaccination. Forty of the infants received vaccine containing the nonacetylated group C polysaccharide C(OAc-) and 78 the acetylated group C polysaccharide C(OAc+) together with group A, Y, and W135 polysaccharides. All polysaccharides, at a dose of 30 µg, induced antibody responses after administration of both vaccines in all age groups although the responses were better in the older infants. Acetylation of the sialic acid of the group C polysaccharide did not significantly influence the response. Rapid decreases in the antibody titers after the first vaccination stressed the need for one or more revaccinations. Vaccination elicited mild local and systemic reactions. Elevated temperatures were more common in the youngest infants but only four developed fever exceeding 38.5°C (101.3°F). We conclude that tetravalent (ACYW135) meningococcal vaccine is safe and immunologically effective in children younger than age 2 years. However, revaccinations may be required to maintain immunity.

Understanding Variations in the Health Consequences of Sedentary Behavior: A Taxonomy of Social Interaction, Novelty, Choice, and Cognition

2021 ◽  
pp. 1-9
Author(s):  
Wendell C. Taylor
Keyword(s):  
Older Adults ◽  
Social Interaction ◽  
Health Outcomes ◽  
Sedentary Behavior ◽  
Age Groups ◽  
Sedentary Behaviors ◽  
Positive Health ◽  
Adverse Health Outcomes ◽  
Important Challenge ◽  
Positive Health Outcomes

The study of sedentary behaviors requires taxonomies (classification schemes) to standardize data collection, measurements, and outcomes. Three taxonomies of sedentary behaviors have been identified, but none address an important challenge in sedentary behavior research, which is to distinguish between beneficial and detrimental health effects of various sedentary behaviors. Some sedentary behaviors (e.g., reading) are associated with positive health outcomes, whereas other sedentary behaviors (e.g., television viewing) are associated with adverse health outcomes. To address directly this complexity and present a different conception and understanding of discrepant findings related to health outcomes, a new taxonomy is needed. The development of the new taxonomy is guided by analysis of literature and selection of a relevant and informative behavioral sciences theoretical framework (i.e., self-determination theory). Because older adults are an increasing percentage of the population and report a high prevalence of sedentary behaviors, the new taxonomy was designed for older adults with potential application to all age groups. Taylor’s taxonomy of sedentary behaviors is parsimonious with four domains: social interaction (i.e., not solitary, companionship, interacting, and connecting with others); novelty (i.e., refreshingly new, unusual, or different); choice (i.e., volition, preferred option or alternative, the power, freedom, or decision to choose); and cognition (i.e., mentally stimulating and engaging).

scholarly journals Morphoquantitative study of the submucous plexus (of Meissner) of the jejunum-ileum of young and old guinea pigs

2011 ◽  
Vol 69 (1) ◽  
pp. 85-90 ◽  
Author(s):  
Marcelo César Zanesco ◽  
Romeu Rodrigues de Souza
Keyword(s):  
Small Intestine ◽  
Guinea Pigs ◽  
Age Groups ◽  
Collagen Fibers ◽  
Submucous Plexus ◽  
The Mean ◽  
Electronic Microscope

OBJECTIVE: To study the aging of submucous plexus of the small intestine (jejunum-ileum) of the guinea pigs from the quantitative, structural and ultrastructural perspective. METHOD: Chemical preparations of membrane of the jejunum-ileum of old and young animals with the use of light and electronic microscope. RESULTS: The ganglia of young animals presented between 1 and 56 neurons and the old animals presented from 1 to 30 neurons. The mean density of the ganglia by cm² in the young jejunum-ileum was of 551±36.89 and in the old one 413±11.86. The density of the neurons was 5011±291.11 neurons/cm² average in young animals and 2918±120.70 neurons/cm² in the old ones. The size of the neurons varied in both age groups. The collagen fibers in the ganglia of old animals they were condensed. Degenerated mitochondrias in the interior of the cell were frequent in the old animals. CONCLUSION: In submucous plexus of the jejunum-ileum there is a loss of 38% of the neurons with aging.

scholarly journals Risk Assessment of "Other Substances" – L-threonine

2020 ◽  
pp. 63-65
Author(s):  
Martinus Løvik ◽  
Livar Frøyland ◽  
Margaretha Haugen ◽  
Sigrun Henjum ◽  
Kristin Holvik ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Food Safety ◽  
Adverse Effects ◽  
Health Effects ◽  
Food Supplements ◽  
Risk Assessments ◽  
Adverse Health Effects ◽  
Adverse Health ◽  
Other Substances ◽  
One Year

The Norwegian Scientific Committee for Food Safety (Vitenskapskomiteen for mattrygghet, VKM) has, at the request of the Norwegian Food Safety Authority (Mattilsynet; NFSA), assessed the risk of "other substances" in food supplements and energy drinks sold in Norway. VKM has assessed the risk of doses given by NFSA. These risk assessments will provide NFSA with the scientific basis while regulating "other substances" in food supplements. "Other substances" are described in the food supplement directive 2002/46/EC as substances other than vitamins or minerals that have a nutritional and/ or physiological e ffect. It is added mainly to food supplements, but also to energy drinks and other foods. In this series of risk assessments of "other substances" the VKM has not evaluated any claimed beneficial effects from these substances, only possible adverse effects. The present report is a risk assessment of specified doses of L-threonine in food supplements, and it is based on previous risk assessments and articles retrieved from literature searches. According to information from NFSA, L-threonine is an ingredient in food supplements sold in Norway. NSFA has requested a risk assessment of 1000, 1200, 1500, 2000 and 2400 mg/day of L-threonine from food supplements.  L-threonine is an essential amino acid not known to cause any adverse health effects. Previous reports do not indicate a tolerable upper intake level, apart from an approval of a dose of 1150 mg/day by the Scientific Committee of the Spanish Agency for Food Safety and Nutrition (AESAN). Long-term studies in humans were not found. The only available human studies were: a small uncontrolled one-year pilot study with doses ranging from 0.5 to 2.5 g/day, one eight-week randomised controlled trial (RCT) using a dose of 7.5 g/day, and two 2-week RCTs using doses of 6 and 4.5 g/day. No adverse effects (diary method of registration of adverse effects) were reported in the eight-week clinical trial, and the only adverse effects observed in the two-week trials were one case of indigestion and one case of diarrhoea. A four-week rodent toxicity study indicated a no observed adverse effect level (NOAEL) of 854.3 mg/kg bw per day (only dose tested, no adverse effects observed).  The value used for comparison with the estimated exposure in the risk characterisation is the NOAEL defined in an 8-week randomised placebo controlled study in humans, 7500 mg/day. For a 70-kg individual, this corresponds to 107 mg/kg bw per day. Two human two-week studies and a small one-year pilot study support the notion that this dose will be well tolerated. The overall mean threonine intake according to NHANES III (3 g/day) is slightly larger than the doses requested for evaluation in the present risk assessment. No studies in children (10 to <14 years) and adolescents (14 to <18 years) were identified. Based on the included literature there was no evidence indicating that age affects the tolerance for relevant doses of threonine. Therefore, in this risk characterisation a tolerance as for adults, based on body weight, was assumed for these age groups. VKM concludes that: In adults (≥18 years), the specified doses 1000, 1200, 1500, 2000 and 2400 mg/day L-threonine in food supplements are unlikely to cause adverse health effects. In adolescents (14 to <18 years), the specified doses 1000, 1200, 1500, 2000 and 2400 mg/day L-threonine in food supplements are unlikely to cause adverse health effects. In children (10 to <14 years), the specified doses 1000, 1200, 1500, 2000 and 2400 mg/day L-threonine in food supplements are unlikely to cause adverse health effects. Children younger than 10 years were not within the scope of the present risk assessment.

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