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Biological Availability clinical trials

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NCT ID: NCT04876261 Completed - Clinical trials for Biological Availability

Bioavailability of Hydroxytyrosol From Olive Watery Extract Supplements

Start date: May 10, 2021
Phase: N/A
Study type: Interventional

The aim of this cross-over study is to assess the bioavailability of hydroxytyrosol in healthy males after the intake of two olive watery extract supplements and one olive oil. Blood and urine samples will be collected before and after intake of the investigational products. Sample will be analysed regarding the level of hydroxytyrosol and preventing lipid peroxidation.

NCT ID: NCT04744233 Completed - Humans Clinical Trials

Bioavailability of Carotenoids From Orange Juice in a Cross-over Study in Healthy Subjects.

Start date: October 2001
Phase: N/A
Study type: Interventional

Commercially available fruit juices are obtained after applying industrial technologies to preserve and extend the shelf-life by inactivation of microorganism and enzymes. These are traditional thermal treatment (eg. pasteurization, sterilization) that causes losses of nutritional and bioactive compounds, changes physicochemical properties (colour, flavor and texture) and can modify their bioavailabilities. Thus, the traditional thermal processing is being replaced by less intense thermal technologies (e.g. low-temperature pasteurization / refrigerated storage) and non-thermal treatments such as the high-pressure processing (HPP) and the pulsed electric fields (PEF) as an alternative to enhace food safety and shelf-life without compromising organoleptic qualities (retain the flavour, color healthiness of fresh foods) and keeping their health-promoting capacity. The beneficial health effect derived from the orange juice intake is partly related to the bioavailability of their bioactive compounds. The aim of this study was to assess the effect of the intake of freshly squeezed orange juice (Citrus sinensis L.) and processed orange juice elaborated with different treatments (low pasteurization / refrigerated storage, high-pressure processing, pulsed electric fields) on the main serum carotenoid concentrations in a cross-over study in apparently healthy subjects using multiple dosis.

NCT ID: NCT04207372 Completed - Clinical trials for Biological Availability

Protein Digestibility of Whey and Zein.

Start date: May 4, 2018
Phase: N/A
Study type: Interventional

The evaluation of protein quality has top priority according to Food and Agricultural Organization of the United Nations. However, one aspect of protein quality, namely the digestibility of protein is largely unknown. A database on this matter is lacking as it is difficult to measure ileal digestibility in humans.

NCT ID: NCT03984916 Completed - Clinical trials for Biological Availability

Study of the Bioavailability of Three Hesperidin Extracts.

HESPERIDIN
Start date: June 13, 2019
Phase: N/A
Study type: Interventional

The flavonoid hesperidin is present abundantly in citrus fruits and citrus juices. The results of numerous studies suggest that hesperidin perform several beneficial effects on health, including antitumor, antioxidant, anti-inflammatory, hypocholesterolemic and hypoglycemic effects as well as decreasing blood pressure. There are two isomers of hesperidin, -S and -R, being the predominant form in nature the isomer -S. However, currently commercialized hesperidin consists of a mixture of both isomers due to the extraction process of the hesperidin from natural sources. The presence of the rutin disaccharide conjugated to the hesperidin molecule is responsible that most of the ingested hesperidin is metabolized by bacteria in the colon through the enzymatic activity α-rhamnosidase, being this enzymatic activity the limiting step of the hydrolysis and absorption of hesperidin. It has been suggested that the low levels of this enzymatic activity in the gut microbiota is the cause of the low bioavailability of hesperidin and also, at least in part , of the high interindividual variability that exists in the absorption of this compound. The micronization process in order to decrease the size of the hesperidin particles is presented as a way to increase the bioavailability of hesperidin. Another way to increase the absorption of hesperidin that is proposed in this study is to increase the proportion of the isomer -S in the extracts of hesperidin, since being the isomer that mostly occurs in nature, the gut microbiota will have a greater capacity of metabolism for this isomer. On this basis the present hypothesis is posed: the administration of hesperidin formed mainly by the isomer -S and micronized, will present greater bioavailability than hesperidin formed by a mixture of the isomers -S and -R. In turn, the bioavailability of the hesperidin formed mainly by the isomer -S and micronized will present greater bioavailability than the mixture of the isomers -S and -R and micronized. The main objective of this study was to quantify the bioavailability of three extracts of hesperidin: - Hesperidin extract with a mixture of the isomers -S and -R. - Hesperidin extract with a mixture of the isomers -S and -R micronized. - Hesperidin extract with the isomer -S micronized.

NCT ID: NCT03951025 Completed - Clinical trials for Biological Availability

Study of the Bioavailability of a Food Supplement Rich in Melatonin Administered Sublingually and Orally (MELATONIN)

MELATONIN
Start date: June 5, 2019
Phase: Phase 2
Study type: Interventional

Sleep disorders represent an important public health problem that cause important personal problems, absenteeism and considerable health costs. Although the main drugs used for the treatment of insomnia are still Benzodiazepines and Z-drugs (Zolpidem, Zopiclone, Zaleplon), these are not entirely effective and have numerous side effects that lead to poor compliance with therapy . For the treatment of sleep disorders, alternative non-pharmacological therapies have also been implemented, such as cognitive therapy, relaxation therapy, and the introduction of new agents, including the use of melatonin as a human endogenous molecule with low or zero toxicity. In Europe, the European Food Safety Authority (EFSA) has stated that "A cause and effect relationship is established between the consumption of melatonin and the alleviation of subjective feelings of jet lag. In order to present the declaration of health, the dose of melatonin should be between 0.5 and 5 mg and should be taken close to bedtime on the first day (and subsequent days) of the trip and the following days after arrival at destination.The target population is the general population ". On the other hand, the EFSA states that "A cause and effect relationship is established between the consumption of melatonin and the reduction of sleep onset latency. The Panel considers that to obtain the declared effect, 1 mg of melatonin should be consumed near bedtime. The target population is the general population." The results of several studies in humans show that melatonin administered orally has a low bioavailability (approximately percentage) and a very short half-life. Therefore, it has been suggested that the sublingual route represents an attractive alternative for the administration of compounds that have a low bioavailability, since through this route, the substances are distributed throughout the body avoiding the loss of the compounds by their first-pass metabolism by the liver, as well as the loss by the process of absorption by the digestive system. On this basis the present hypothesis is posed: the administration of melatonin sublingually will have a greater bioavailability than the administration of melatonin orally. The main objective of this study was to quantify the bioavailability of 1 mg of melatonin when administered sublingually and orally.

NCT ID: NCT03886766 Completed - Clinical trials for Biological Availability

Bioavailability Mechanistic Study of Hot-Melt Extruded Amorphous Solid Dispersions

BEAD
Start date: April 30, 2019
Phase: N/A
Study type: Interventional

It is the aim of the study to investigate the functioning of a drug delivery system (drug-rich particles forming hot-melt extruded amorphous solid dispersions) with respect to mechanisms of bioavailability of poorly soluble drug substances.

NCT ID: NCT03886597 Completed - Healthy Clinical Trials

Nutritional Intervention With Table Olives in Healthy Volunteers

BIOLIVA
Start date: March 25, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

Olives and olive oil are typical components of the Mediterranean diet being part of its cultural and gastronomic heritage. Since ancient times, olives have been used either for both, oil extraction or whole fruit consumption as table olives. Olive oil stands out from both the nutritional and the health point of view. However, the effect of table olives consumption remains almost unknown. The beneficial properties of olive oil have been initially ascribed to the high concentration of oleic acid. Nowadays, these positive effects have been attributed also to minor compounds such as polyphenols or pentacyclic triterpenes. Table olives contain a higher amount of both polyphenols and pentacyclic triterpenes than their oil, with the same healthy fatty acid profile. Therefore, the present intervention aims at investigating the pharmacokinetic of polyphenols and pentacyclic triterpenes after a single olive intake as well as the assessment of the effect of the consumption of olives during 30 days on the overall health status playing particular attention to the anti-inflammatory, antioxidant and cardiovascular biomarkers.

NCT ID: NCT03873909 Completed - Clinical trials for Biological Availability

Bioavailability of Carotenoids Present in Mamey Sapote (Pouteria Sapota (Jacq.) H. E. Moore & Stearn) Fruit

Start date: October 1, 2017
Phase: N/A
Study type: Interventional

The goal of the study is to determine if mamey sapote fruit, rich in rare potentially provitamin A keto-carotenoids, is a good source of vitamin A in humans. Furthermore, it will help to compare the absorption of carotenoids between the fruit versus a "matrix-free" formulation. The objective will be accomplished by quantitation of the immediate post-prandial plasma concentrations of parent carotenoids and vitamin A metabolites from participants consuming a meal consisting of a mamey sapote fruit smoothie or a shake containing mamey sapote encapsulated carotenoids.

NCT ID: NCT03773068 Completed - Clinical trials for Biological Availability

A Study in Healthy Volunteers Investigating How Quickly and to What Extent BAY1817080 is Taken up, Distributed, Broken Down and Eliminated From the Body, as Well as the Difference Between 2 Different Types of Tablets of BAY1817080 and the Difference Between Oral Dose and Dose in the Vein

Start date: December 13, 2018
Phase: Phase 1
Study type: Interventional

The main purpose of this study is to investigate how quickly and to what extent BAY1817080 is absorbed (taken up), distributed, metabolized (broken down) and eliminated from the body (this is called pharmacokinetics). The pharmacokinetics of BAY1817080 administered as tablets will be compared to the pharmacokinetics of BAY1817080 administered as intravenous (iv; in the vein) infusion (this is called absolute bioavailability). Furthermore, 2 different types of tablets with BAY1817080 (Formulation A and Formulation B) will be compared with regard to pharmacokinetics (this is called relative bioavailability). The effect of a meal on the pharmacokinetics of BAY1817080 administered as tablets will be investigated as well. Finally, it will also be investigated how safe BAY1817080 is and how well BAY1817080 is tolerated.

NCT ID: NCT03612700 Completed - Clinical trials for Biological Availability

Presence of Cyclopropane Fatty Acids (CPFA) in Human Plasma

Start date: August 6, 2018
Phase: N/A
Study type: Interventional

Fatty acids containing a cyclopropane ring in their structure (CPFA) have been found in plants, fungi, a wide variety of bacteria and recently detected in dairy products and bovine meat. Little is known about CPFA in mammals, especially in human tissues. This work aims at investigating the presence of CPFA in plasma of humans after a regular consumption of CPFA from milk and cheese. A free living diet controlled in CPFA, mainly deriving from Grana Padano cheese and whole milk containing CPFA, will be consumed by 10 healthy normal weight volunteers for three weeks, after one week of dairy products and bovine meat restricted diet. Plasma of volunteers will be collected at 8 different timepoints for lipid extraction, CPFA identification and quantification by GC-MS. A preliminary pilot in vivo acute study (involving only 1 subject) will be performed for investigating the post-prandial response curve of CPFA after a portion of Grana Padano cheese.