Schön Christiane, Micka Antje, Gourineni Vishnupriya, Bosi Roberta
BioTeSys GmbH, Esslingen, Germany.
Evonik Corporation GmbH, Piscataway, NJ, USA.
Food Nutr Res. 2024 Dec 27;68. doi: 10.29219/fnr.v68.11028. eCollection 2024.
Omega-3 fatty acids, including eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), are polyunsaturated fatty acids (PUFAs) with notable health benefits. Due to limited physiological production and insufficient dietary supply, external supplementation is important.
This study aimed to compare the pharmacokinetics and bioavailability of EPA and DHA in AvailOm omega-3-lysine salt (Lys-FFA) versus standard ethyl ester (EE) and triglyceride (TG) formulations after a single oral dose in healthy subjects.
A randomized, three-way crossover study was conducted with 21 healthy subjects.
Twenty-one subjects (10 men, 11 women) completed the study. The average age was 41.7 years, and the mean body mass index was 23.0 kg/m. The Lys-FFA formulation showed significantly higher uptake of omega-3 fatty acids (EPA+DHA combined and each individually) compared to EE. Specifically, Lys-FFA had a 9.33-fold (0-12 h) and 8.09-fold (0-24 h) higher bioavailability of EPA+DHA than EE and a 1.57-fold (0-12 h) and 1.44-fold (0-24 h) higher bioavailability than TG. ΔCmax and Tmax also favored Lys-FFA over EE.
Under fasting conditions, the absorption of EPA and DHA from EE is limited due to the need for enzymatic cleavage before absorption. This requirement is bypassed with Lys-FFA, which does not need cleavage.
The study demonstrates that EPA and DHA lysine salt (Lys-FFA) offers superior bioavailability compared to EE and triglyceride forms, presenting a more effective supplementation option.German Clinical Trials Register, DRKS-ID: DRKS00029183.
ω-3脂肪酸,包括二十碳五烯酸(EPA)和二十二碳六烯酸(DHA),是具有显著健康益处的多不饱和脂肪酸(PUFA)。由于生理产量有限且膳食供应不足,外部补充很重要。
本研究旨在比较健康受试者单次口服剂量后,AvailOmω-3赖氨酸盐(Lys-FFA)与标准乙酯(EE)和甘油三酯(TG)制剂中EPA和DHA的药代动力学和生物利用度。
对21名健康受试者进行了一项随机、三向交叉研究。
21名受试者(10名男性,11名女性)完成了研究。平均年龄为41.7岁,平均体重指数为23.0kg/m。与EE相比,Lys-FFA制剂显示出ω-3脂肪酸(EPA+DHA总和及各自单独)的摄取显著更高。具体而言,Lys-FFA的EPA+DHA生物利用度比EE高9.33倍(0-12小时)和8.09倍(0-24小时),比TG高1.57倍(0-12小时)和1.44倍(0-24小时)。ΔCmax和Tmax也表明Lys-FFA优于EE。
在禁食条件下,EE中EPA和DHA的吸收有限,因为吸收前需要酶促裂解。Lys-FFA无需裂解,绕过了这一需求。
该研究表明,与EE和甘油三酯形式相比,EPA和DHA赖氨酸盐(Lys-FFA)具有更高的生物利用度,是一种更有效的补充选择。德国临床试验注册中心,DRKS-ID:DRKS00029183。