An innovative approach to the determination of safety for a dietary ingredient derived from a new source: case study using a crystalline lutein product

Krüger, Caroline; Murphy, Michael R.; DeFREITAS, Z.; Pfannkuch, F; Heimbach, James T.

doi:10.1016/s0278-6915(02)00131-x

Cited by 65 publications

(53 citation statements)

References 27 publications

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“…While specific recommendations do not exist for these carotenoids, one can estimate prudent intakes based on carotenoid consumption of individuals meeting fruit and vegetable recommendations, the primary dietary source of carotenoids [19]. Prudent intakes range from 8 -9 mg/d [20] for lycopene and 4 -7 mg/d of lutein + zeaxanthin [21] and are more than double the intakes in the current cohort; only 5 and 6 subjects (<7%), respectively, achieved mean daily intakes from food within these ranges. These findings support the promotion of carotenoid-rich fruit and vegetable intake for lactating women, as lycopene has been shown to be an important antioxidant in both mother and infant health [22] while lutein has a critical role in development of the fovea in the first four months of life [23] and concentrations of lutein in breast milk are highly correlated with maternal intake [11].…”

Section: Intakes Of Individual Nutrientsmentioning

confidence: 99%

Nutrient Intakes from Food of Lactating Women Do Not Meet Many Dietary Recommendations Important for Infant Development and Maternal Health

Pratt¹,

Durham²,

Sherry³

2014

FNS

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Literature describing dietary intakes of lactating mothers in the United States (US) is limited and none of the existing studies attempts to identify whether dietary shortcomings of lactating mothers are distinct from those of women of childbearing age in the US. The first objective of this observational study was to comprehensively analyze the dietary intakes of lactating mothers in the US to determine whether nutrient intakes from food were sufficient to meet recommendations. The second objective was to compare these intakes to those of women of childbearing age in the US. Weekly 3-day food records were collected from subjects for six weeks in 2012-2013. Subject mean daily intakes of food groups, macronutrients, vitamins, minerals, carotenoids, and specific fats including omega-3 and omega-6 fatty acids were determined and compared to daily recommendations. Intakes were compared to US women using the 2009-2010 National Health and Nutrition Examination Survey. Fruit, vegetable, and dairy intakes of mothers were ≤50% of recommendations, resulting in 12 of 26 analyzed vitamins or minerals including potassium, iodine, chromium, choline, and vitamins A, D, and E having mean daily intakes below the Estimated Average Requirement. Vitamin D intake of subjects was 18% lower than US women, while most other nutrients showed intakes within 10% of each other between populations. Lactating women are not meeting the increased dietary needs associated with breastfeeding, supporting education initiatives and interventions specifically tailored to breastfeeding populations to increase intakes of vitamin D, vitamin E, iodine, biotin, carotenoids, and polyunsaturated fatty acids from food.

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Section: Intakes Of Individual Nutrientsmentioning

confidence: 99%

Nutrient Intakes from Food of Lactating Women Do Not Meet Many Dietary Recommendations Important for Infant Development and Maternal Health

Pratt¹,

Durham²,

Sherry³

2014

FNS

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“…A 4-week pilot toxicity study was conducted in rats (Han Wistar) to determine the oral toxicity following administration in the diet of a lutein product derived from marigold flowers (Kruger et al 2002). A compositional analysis of the product used identified 97 % of the components and indicated that 84 % of the product consisted of the carotenoids lutein and zeaxanthin at 79 and 5% concentration respectively.…”

Section: Toxicity Data On Luteinmentioning

confidence: 99%

“…A compositional analysis of the product used identified 97 % of the components and indicated that 84 % of the product consisted of the carotenoids lutein and zeaxanthin at 79 and 5% concentration respectively. Waxes, palmitic acid/palmitate, potassium and water made up the remainder (Kruger et al 2002). Seven dose groups were used, including the control (0, 2.6, 7.7, 26.0, 77.3, 260 and 773.2 mg of lutein product/kg bw/ day).…”

Section: Toxicity Data On Luteinmentioning

confidence: 99%

“…In addition a 13-week diet toxicity study in rats (Han Wistar) was conducted, consisting of three treatment groups and one control group (0, 2.6, 26 and 260 mg lutein (similar specifications as described above)/kg bw/day) (Kruger et al 2002). This study was performed according to OECD guideline 408 (OECD 1998).…”

Section: Toxicity Data On Luteinmentioning

confidence: 99%

“…The mutagenic potential of lutein product (source marigold, same material as used in the 4-week and 13-week study) was investigated in the Ames test according to the guidelines laid down in OECD 471 (OECD 1997) (Kruger et al 2002). Two formulations were tested: beadlets containing 10% lutein product and lutein product as such.…”

Section: Mutagenicitymentioning

confidence: 99%

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Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food on a request from the commission related to Lutein for use in particular nutritional uses

2007

EFSA Journal

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SUMMARYThe Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food has been asked to evaluate lutein, extracted from Tagetes erecta (marigold flowers) and from some species of edible plants, for use in the manufacture of foods for particular nutritional uses (FPNUs). Lutein, extracted from Tagetes erecta and from other species of edible plants, is already permitted for use as a food additive (E161b). The requested product has the same specifications as the approved food additive.Results from human intervention studies with foods high in lutein plus zeaxanthin, with lutein supplements using marigold as the lutein source or with enteral tube feeding containing lutein, indicate that lutein from these sources is bioavailable.The petitioner's proposed use of lutein is in foods for special medical purposes (FSMPs) at levels that would give rise to daily intakes of 0.5 to 2 mg lutein per day. This is within the range of a regular dietary intake.Lutein extracted from the natural strains of edible fruits and plants, grass, Lucerne (alfalfa) and Tagetes erecta (marigold flowers) is already permitted as a food additive (colour). Based on that, the Panel concluded that the use of lutein, obtained as an extract from Tagetes erecta and from the natural strains of edible fruits and plants, grass, lucerne (alfalfa) and Tagetes erecta in FSMPs, is not of safety concern under the proposed use levels which are in the range of the regular dietary intake of lutein, provided that it is in compliance with the existing EU specifications of the food additive.

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Protective Effects of Carotenoids in Cardiovascular Disease and Diabetes

Emanuelli

Augusti

Roehrs

2017

Fruit and Vegetable Phytochemicals

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An innovative approach to the determination of safety for a dietary ingredient derived from a new source: case study using a crystalline lutein product

Cited by 65 publications

References 27 publications

Nutrient Intakes from Food of Lactating Women Do Not Meet Many Dietary Recommendations Important for Infant Development and Maternal Health

Nutrient Intakes from Food of Lactating Women Do Not Meet Many Dietary Recommendations Important for Infant Development and Maternal Health

Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food on a request from the commission related to Lutein for use in particular nutritional uses

Protective Effects of Carotenoids in Cardiovascular Disease and Diabetes

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