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BioTeSys publiziert regelmäßig wissenschaftliche Artikel zu unterschiedlichen Themen aus dem Umfeld der Prüfung und wissenschaftlichen Absicherung von biologischen und chemischen Produkten.

Publikation: 02. Mai 2022

Enhanced Oral Bioavailability of β-Caryophyllene in Healthy Subjects Using the VESIsorb® Formulation Technology, a Novel Self-Emulsifying Drug Delivery System (SEDDS)

β-Caryophyllene (BCP), a common constituent of many spice and food plants, is gaining increased attention due to recent research identifying numerous potential health benefits. Due to limited oral bioavailability observed in preclinical models, the described benefits of BCP may be maximized by using a suitable delivery system. Additionally, human pharmacokinetics (PK) remain unknown. This study evaluates the relative oral bioavailability of BCP formulated in a self-emulsifying drug delivery system (SEDDS) based on VESIsorb® formulation technology (BCP-SEDDS) compared to BCP neat oil. Hence, a randomized, double-blind, cross-over design, single oral dose study (100 mg BCP) in 24 healthy subjects (12 men/12 women) was performed under fasting conditions. Pharmacokinetic parameters were analyzed from individual concentration-time curves. In conclusion, BCP-SEDDS offers a well-tolerated and effective oral delivery system to significantly enhance the oral bioavailability of BCP in humans.

Publikation: 28. April 2022

UC-II® Undenatured Type II Collagen Reduces Knee Joint Discomfort and Improves Mobility in Healthy Subjects: A Randomized, Double- Blind, Placebo-Controlled Clinical Study

Joint discomfort is a common issue in athletes and healthy, active individuals. The objective of this study was to evaluate the efficacy of UC-II® undenatured type II collagen (Undenatured Collagen) in managing knee joint discomfort and mobility in healthy subjects with Activity-related Joint Discomfort (ArJD). Subjects who reported knee pain of 5 on an 11-point Likert scale while performing a Single-Leg-Step-Down (SLSD) test were randomized to receive placebo (PLA, n=48), or Undenatured Collagen (n=48) for 24 weeks. In conclusion, the data suggests Undenatured Collagen reduces joint discomfort and improves mobility.

Publikation: 04. April 2022

UC-II Undenatured Type II Collagen for Knee Joint Flexibility: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study

Joint-related stress models have been used in the past to induce a standardized load on physical structures, allowing researchers to observe changes in perceived stress on joints as accurately as possible in healthy individuals. Previous studies support the efficacy of UC-II® undenatured type II collagen ("undenatured collagen") supplementation in maintaining joint health. The purpose of this study was to assess the effect of undenatured collagen on knee flexibility in healthy subjects who experience activity-related joint discomfort (ArJD). This randomized, double-blind, placebo (PLA)-controlled study was conducted in healthy subjects with ArJD who had no history of osteoarthritis, or joint diseases. Ninety-six (n = 96, 20-55 years old) subjects who reported joint discomfort while performing a standardized single-leg-step-down test were randomized to receive either PLA (n = 48) or 40 mg of undenatured collagen (n = 48) supplementation daily for 24 weeks. Range of motion (ROM) flexion and extension were measured using a digital goniometer. Overall, the results suggest that daily supplementation of 40 mg of undenatured collagen improved knee joint ROM flexibility and extensibility in healthy subjects with ArJD.

Publikation: 29. Dezember 2021

A Synbiotic Formulation Comprising Bacillus subtilis DSM 32315 and L-Alanyl-L-Glutamine Improves Intestinal Butyrate Levels and Lipid Metabolism in Healthy Humans

The gut microbiota is a crucial modulator of health effects elicited by food components, with SCFA (short chain fatty acids), especially butyrate, acting as important mediators thereof. We therefore developed a nutritional synbiotic composition targeted at shifting microbiome composition and activity towards butyrate production. An intestinal screening model was applied to identify probiotic Bacillus strains plus various amino acids and peptides with suitable effects on microbial butyrate producers and levels. A pilot study was performed to test if the synbiotic formulation could improve fecal butyrate levels in healthy humans. In conclusion, our study indicates that this synbiotic composition may provide an effective and safe tool for stimulation of intestinal butyrate production with effects on e.g., lipid and glucose homeostasis. Further investigations in larger cohorts are warranted to confirm and expand these findings.

Publikation: 08. Dezember 2021

Habitual Choline Intakes across the Childbearing Years: A Review

Choline is an important nutrient during the first 1000 days post conception due to its roles in brain function. An increasing number of studies have measured choline intakes at the population level. We collated the evidence focusing on habitual choline intakes in the preconceptual, pregnancy, and lactation life stages. We conducted a review including studies published from 2004 to 2021. Twenty-three relevant publications with an average choline intake range of 233 mg/day - 383 mg/day were selected. To conclude, during the childbearing years and across the globe, habitual intakes of choline from foods alone and foods and supplements combined appear to be consistently lower than the estimated adequate intakes for this target group. Urgent measures are needed to (1) improve the quality of choline data in global food composition databases, (2) encourage the reporting of choline intakes in dietary surveys, (3) raise awareness about the role(s) of choline in foetal-maternal health, and (4) consider formally advocating the use of choline supplements in women planning a pregnancy, pregnant, or lactating.

Publikation: 30. November 2021

Do low molecular weight antioxidants contribute to the Protection against oxidative damage? The interrelation between oxidative stress and low molecular weight antioxidants based on data from the MARK-AGE study

Oxidative Stress (OS) is associated with (or/and caused by) excessive production of damaging reactive oxygen and/or nitrogen species (ROS, RNS), which play a role in many pathologies. Because OS is a risk factor for many diseases, much effort (and money) is devoted to early diagnosis and treatment of OS. The desired benefit of the "identify (OS) and treat (by low molecular weight antioxidants, LMWA)" approach is to enable selective treatment of patients under OS. The present work aims at gaining understanding of the benefit of the antioxidants based on interrelationship between the concentration of different OS biomarkers and LMWA. We studied the effects of 12 LMWA (including tocopherols, carotenoids and ascorbic acid) on the OS status, as observed with 8 biomarkers of oxidative damage (including malondialdehyde, protein carbonyls, 3-nitrotyrosine). In view of the results as well as the difficulty of quantitating the OS and the very different effects of various LMWA, the use of the "identify and treat" approach is questionable.

Publikation: 15. November 2021

Age, Sex, and BMI Influence on Copper, Zinc, and Their Major Serum Carrier Proteins in a Large European Population Including Nonagenarian Offspring From MARK-AGE Study

The analysis of copper (Cu) and zinc (Zn) along with their major serum carriers, albumin (Alb) and ceruloplasmin (Cp), could provide information on the capacity of humans to maintain homeostasis of metals (metallostasis). However, their relationship with aging, sex, body mass index, as well as with nutritional and inflammatory markers was never investigated in a large-scale study. Here, we report results from the European large-scale cross-sectional study MARK-AGE in which Cu, Zn, Alb, Cp, as well as nutritional and inflammatory parameters were determined in 2424 age-stratified participants (35-75 years), including the general population (RASIG), nonagenarian offspring (GO), a well-studied genetic model of longevity, and spouses of GO (SGO). Our results show that aging, sex, body mass index, and GO status are characterized by different levels of Cu, Zn, and their serum carrier proteins. These data and their relationship with inflammatory biomarkers support the concept that loss of metallostasis is a characteristic of inflammaging

Publikation: 11. Oktober 2021

New Self-Assembling Formulation Technology Improves Transepithelial Transport of Curcuminoids in Vitro and is Capable to Support the Rising Wishes for Sustainable Vegan Nutrition

The relative bioavailability of lipophilic nutritional supplements is largely dependent on the delivery system. This is especially true for curcumin, which is extracted from the turmeric root (Curcuma longa L.) and which is becoming increasingly popular due to its antioxidant, anti-inflammatory and other described health protecting properties. In the present study, we present a new technology as delivery system for lipophilic compounds, the Vitaresorp® technology. In this study, we present comparative data for the transepithelial transport of curcuminoids using the new technology with different phospholipids or powder across the epithelium of the widely used CaCo-2 cell model after an in vitro simulation of the digestion process. The results demonstrate the formation of nanosized particles with improved adherence to intestinal cells and up to 6-fold improved transepithelial transport of curcuminoids compared to powder when delivered with the Vitaresorp® technology.

Publikation: 26. Juli 2021

Microbiome in Blood Samples From the General Population Recruited in the MARK-AGE Project: A Pilot Study

The presence of circulating microbiome in blood has been reported in both physiological and pathological conditions, although its origins, identities and function remain to be elucidated. This study aimed to investigate the presence of blood microbiome by quantitative real-time PCRs targeting the 16S rRNA gene. The samples came from several different European countries recruited within the EU Project MARK-AGE in which a series of clinical biochemical parameters were determined. The results obtained reveal an association between microbial DNA copy number and geographic origin. By contrast, no gender and age-related difference emerged, thus demonstrating the role of the environment in influencing the above levels independent of age and gender at least until the age of 75. In addition, a significant positive association was found with Free Fatty Acids (FFA) levels, leukocyte count, insulin, and glucose levels. Since these factors play an essential role in both health and disease conditions, their association with the extent of the blood microbiome leads us to consider the blood microbiome as a potential biomarker of human health.

Publikation: 13. Juli 2021

A Food Supplement with Antioxidative Santa Herba Extract Modulates Energy Metabolism and Contributes to Weight Management

The plant Santa herba (Eriodictyon californicum) contains high flavonoids, thus potentially exerting beneficial effects in context of obesity, often accompanied by inflammation and metabolic imbalance. The study assessed the impact of Santa herba on oxidative stress, energy metabolism, weight reduction, and eating behavior, combining in vitro models with clinical data. Santa herba binding of the adenosine receptor A2A (ADORA2A) was assessed using a radioligand binding assay. A Caenorhabditis elegans model was used to determine mobility boosting effects, and Santa herba oxygen radical absorbance capacity (ORAC) values were determined in comparison to antioxidative plants. Clinical data, that is, body weight and appetite-related parameters, were obtained from overweight and obese women receiving either Santa herba or placebo for 12 weeks. Results showed that Santa herba extract has energizing and antioxidative properties and may aid in weight management of people with obesity.