Clinical Trial in Healthy Volunteers and Subjects With CDK

ABSTRACT BACKGROUND Abbreviation of preoperative fasting to 2 hours with maltodextrin (CHO)-enriched beverage is a safe procedure and may enhance postoperative recovery. Addition of glutamine (GLN) to CHO beverages may include potential benefits to the metabolism. However, by adding a nitrogenous source to CHO beverages, gastric emptying may be delayed and increase the risk of bronchoaspiration during anesthesia. OBJECTIVE In this study of safety, we aimed at investigating the residual gastric volume (RGV) 2 hours after the intake of either CHO beverage alone or CHO beverage combined with GLN. METHODS We performed a randomized, crossover clinical trial. We assessed RGV by means of abdominal ultrasonography (US) in 20 healthy volunteers (10 males and 10 females) after an overnight fast of 8 hours. Then, they were randomized to receive 600 mL (400 mL immediately after US followed by another 200 mL 2 hours afterwards) of either CHO (12.5% maltodextrin) or CHO-GLN (12.5% maltodextrin plus 15 g GLN). Two sequential US evaluations were done at 120 and 180 minutes after ingestion of the second dose. The interval of time between ingestion of the two types of beverages was 2 weeks. RESULTS The mean (SD) RGV observed after 8 hours fasting (13.56±13.25 mL) did not statistically differ (P>0.05) from the RGV observed after ingesting CHO beverage at both 120 (16.32±11.78 mL) and 180 minutes (14.60±10.39 mL). The RGV obtained at 120 (15.63±18.83 mL) and 180 (13.65±10.27 mL) minutes after CHO-GLN beverage also was not significantly different from the fasting condition. CONCLUSION The RGV at 120 and 180 minutes after ingestion of CHO beverage combined with GLN is similar to that observed after an overnight fast.

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Decrease of ultraviolet A light–induced “common deletion” in healthy volunteers after oral Polypodium leucotomos extract supplement in a randomized clinical trial

Journal of the American Academy of Dermatology ◽

10.1016/j.jaad.2009.05.045 ◽

2010 ◽

Vol 62 (3) ◽

pp. 511-513 ◽

Cited By ~ 22

Author(s):

Adriana Villa ◽

Martha H. Viera ◽

Sadegh Amini ◽

Ran Huo ◽

Oliver Perez ◽

...

Keyword(s):

Clinical Trial ◽

Healthy Volunteers ◽

Randomized Clinical Trial ◽

Ultraviolet A ◽

Common Deletion ◽

Polypodium Leucotomos

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Screening and Recruitment Procedures of Healthy Volunteers In A Phase I Clinical Trial Unit: Experience In 64 Bioequivalence Studies

Clinical Therapeutics ◽

10.1016/j.clinthera.2015.05.367 ◽

2015 ◽

Vol 37 (8) ◽

pp. e129

Author(s):

B. Duque ◽

A.M. Borobia ◽

R. Lubomirov ◽

E. Ramirez ◽

P. Guerra ◽

...

Keyword(s):

Clinical Trial ◽

Phase I ◽

Healthy Volunteers ◽

Clinical Trial Unit ◽

Phase I Clinical Trial

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A clinical trial on the acute effects of methadone and buprenorphine on actual driving and cognitive function of healthy volunteers

British Journal of Clinical Pharmacology ◽

10.1111/bcp.13818 ◽

2018 ◽

Vol 85 (2) ◽

pp. 442-453 ◽

Cited By ~ 6

Author(s):

Maren Cecilie Strand ◽

Vigdis Vindenes ◽

Hallvard Gjerde ◽

Jørg Gustav Mørland ◽

Johannes G. Ramaekers

Keyword(s):

Clinical Trial ◽

Cognitive Function ◽

Healthy Volunteers ◽

Acute Effects

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Effect of Red Wine Intake on Serum and Salivary Melatonin Levels: A Randomized, Placebo-Controlled Clinical Trial

Molecules ◽

10.3390/molecules23102474 ◽

2018 ◽

Vol 23 (10) ◽

pp. 2474 ◽

Cited By ~ 1

Author(s):

Elena Varoni ◽

Rita Paroni ◽

Jacopo Antognetti ◽

Giovanni Lodi ◽

Andrea Sardella ◽

...

Keyword(s):

Clinical Trial ◽

Healthy Volunteers ◽

Red Wine ◽

Statistical Significance ◽

Serum Levels ◽

Controlled Clinical Trial ◽

Salivary Melatonin ◽

The One ◽

To Receive

Melatonin (MLT) is a recently discovered phytochemical in wine, but its influence on physiological MLT levels is still unknown. This study aimed at evaluating variations, in serum and saliva, of MLT concentrations after the intake of MLT-enriched red wine. Twelve healthy volunteers were recruited to receive 125 mL of red wine naturally lacking of MLT (placebo, PLC), or the same wine enriched with MLT (MLT+). A physiological steady decline of serum MLT was observed from baseline up to 90 min, for both wines. After PLC intake, the decrease was significantly faster than the one occurring after MLT+ wine, which thus delayed the drop down of serum MLT with a plateau at 30–60 min. Salivary MLT levels slightly peaked at 45 min after MLT+ wine intake, without statistical significance. Therefore, the intake of a glass of MLT-enriched red wine changed serum levels of the indoleamine, supporting the role of wine MLT in counteracting the physiological decline of the hormone into the bloodstream.

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A Study on the Characteristics of Healthy Volunteers who Participate in Phase I Clinical Trials in Korea

Journal of Empirical Research on Human Research Ethics ◽

10.1177/15562646211034275 ◽

2021 ◽

pp. 155626462110342

Author(s):

Ji-Hye Seo ◽

Ock-Joo Kim ◽

Sang-Ho Yoo ◽

Eun Kyung Choi ◽

Ji-Eun Park

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Phase I ◽

Healthy Volunteers ◽

Health Science ◽

Trial Participation ◽

Phase I Clinical Trials ◽

Financial Reward ◽

Therapeutic Purpose ◽

The Republic

The phase I trial is the first step in administering a drug to humans, but it has no therapeutic purpose. Under the absence of therapeutic purpose, healthy volunteers demonstrated different motivations, unlike the actual patients participating in trials. There were many reported motivations, such as financial motivation, contributing to the health science, accessing ancillary health care benefits, scientific interest or interest in the goals of the study, meeting people, and general curiosity. The aim of this study was to identify the motivation and characteristics of healthy volunteers participating in phase I trials in the Republic of Korea. We gave surveys to 121 healthy volunteers to study their demographic characteristics and the reasons of participation. We identified whether the decision to participate in the research was influenced by demographic factors and whether the perception and attitudes toward the research were influenced by the characteristics of the healthy volunteers. After completion of the first survey, 12 healthy volunteers who had participated in a phase I clinical trial were selected to answer the second interview. According to our survey, most healthy volunteers were unmarried men and economically dependent. Most of them participated in the study because of financial reward. The most important factor to measure financial reward was the research period. Also, 43% of the volunteers were university students, 42% answered “university graduation” and 55% were residing in family-owned houses. Many healthy volunteers were found to be living in family homes and to have a student status or lack of economic independence. Results of the survey showed that 64% of respondents indicated having more than one clinical trial participation. In-depth interviews showed that healthy volunteers had diverse motivation to participate in research and that healthy volunteer perceive the clinical trial positively. The main motivation for healthy volunteers’ participation in research was “financial reward.” Healthy volunteers also considered research schedules, processes, and safety, and had a positive perception of clinical trials, but they thought that the public has a negative perception.

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Neuroplasticity induced by general anaesthesia: study protocol for a randomised cross-over clinical trial exploring the effects of sevoflurane and propofol on the brain – A 3-T magnetic resonance imaging study of healthy volunteers

Trials ◽

10.1186/s13063-020-04468-y ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Signe Sloth Madsen ◽

Kirsten Møller ◽

Karsten Skovgaard Olsen ◽

Mark Bitsch Vestergaard ◽

Ulrich Lindberg ◽

...

Keyword(s):

Magnetic Resonance Imaging ◽

Clinical Trial ◽

Cognitive Function ◽

Magnetic Resonance ◽

Healthy Volunteers ◽

General Anaesthesia ◽

Well Being ◽

Resonance Imaging ◽

Link Type ◽

The Brain

Abstract Background Although used extensively worldwide, the effects of general anaesthesia on the human brain remain largely elusive. Moreover, general anaesthesia may contribute to serious conditions or adverse events such as postoperative cognitive dysfunction and delirium. To understand the basic mechanisms of general anaesthesia, this project aims to study and compare possible de novo neuroplastic changes induced by two commonly used types of general anaesthesia, i.e. inhalation anaesthesia by sevoflurane and intravenously administered anaesthesia by propofol. In addition, we wish to to explore possible associations between neuroplastic changes, neuropsychological adverse effects and subjective changes in fatigue and well-being. Methods This is a randomised, participant- and assessor-blinded, cross-over clinical trial. Thirty healthy volunteers (male:female ratio 1:1) will be randomised to general anaesthesia by either sevoflurane or propofol. Multimodal magnetic resonance imaging (MRI) of the brain will be performed before and after general anaesthesia and repeated after 1 and 8 days. Each magnetic resonance imaging session will be accompanied by cognitive testing and questionnaires on fatigue and well-being. After a wash-out period of 4 weeks, the volunteers will receive the other type of anaesthetic (sevoflurane or propofol), followed by the same series of tests. Primary outcomes: changes in T1-weighted 3D anatomy and diffusion tensor imaging. Secondary outcomes: changes in resting-state functional magnetic resonance imaging, fatigue, well-being, cognitive function, correlations between magnetic resonance imaging findings and the clinical outcomes (questionnaires and cognitive function). Exploratory outcomes: changes in cerebral perfusion and oxygen metabolism, lactate, and response to visual stimuli. Discussion To the best of our knowledge, this is the most extensive and advanced series of studies with head-to-head comparison of two widely used methods for general anaesthesia. Recruitment was initiated in September 2019. Trial registration Approved by the Research Ethics Committee in the Capital Region of Denmark, ref. H-18028925 (6 September 2018). EudraCT and Danish Medicines Agency: 2018-001252-35 (23 March 2018). www.clinicaltrials.gov, ID: NCT04125121. Retrospectively registered on 10 October 2019.

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