Clinical trial NCT06380998: Effects of Petroleum Compounds on Psychological Health and Cognitive Functions
Official title: Effects of Petroleum Compounds on Psychological Health, Cognitive Functions, and the Possible Ameliorating Effect of Whey Protein in a Sample of Petrol Station Workers in Assiut Governorate
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cognitive Deterioration
Keywords: Petroleum compounds
psychological heath
cognitive funtions
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-04-24
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Petrol station workers at Assiut fuel stations with exposure time of 8 continuous hours for at least 2 years

Brief summary: Over the last decade, awareness of the effects of hydrocarbon fuels on neurodegenerative disorders has increased significantly, as they are ubiquitous environmentally toxic chemicals that affect the central nervous system and result in irreversible neuronal damage, as many hydrocarbons can cross the blood-brain barrier through multiple pathways and cause direct toxicity.

Detailed description: Petrol stations are establishments that retail liquid fuels derived from petroleum, alcohol, and other automotive fuels, with equipment available for their measurement and storage. This process, linked to gasoline distribution, can be a significant source of volatile organic compounds (VOCs), such as benzene, toluene, ethylbenzene, and xylene isomers (BTEX), the primary volatile hydrocarbons derived from petroleum.

Headache, fatigue, dizziness, respiratory tract infections, skin allergies, eye infections, and impairment of memory have been experienced by a few people immediately following exposure to some solvents. CNS depression is a common physiological outcome caused by high exposure to some VOCs. General anaesthetic effects, and as a most severe outcome, unconsciousness and, in some cases, death, may occur at the end.

Long-term exposure to organic solvents may cause permanent central nervous system disturbances, a condition called chronic solvent encephalopathy (CSE).

Cognitive symptoms and neuropsychological signs, or issues with memory, focus, and learning, are the hallmarks of CSE, which is underdiagnosed and characterized by these symptoms as well as possible side effects like headaches, fatigue, balance issues, and mild depression. If exposure stops, though, the illness will not worsen.

We are discovering more about the importance of nutrition and its impact on an individual's susceptibility to illness progression. Diet has been suggested to have an important role in cognitive health and the development of dementia. However, most of the intervention studies conducted to date have mainly assessed the effect of dietary supplements on cognitive function.

The toxicity of inhaled vapours is due to their biotransformation into reactive oxygen species, and several studies have highlighted the capacity of whey protein to increase glutathione (GSH), suggesting that this complex mixture is capable of boosting GSH synthesis, thus reducing oxidative stress.

Eligibility criteria: Inclusion Criteria:

* Workers in direct contact with petroleum compounds in petroleum stations.
* Working for at least 8 continuous hours daily for at least 2 years before enrollment in the study.
* Participants have willingness to participate and have no history for substance abuse

Exclusion Criteria:

* Working for less than 2 years with interrupted exposure.
* The exposure of workers to petroleum compounds is indirect.
* History of psychological and neurodegenerative diseases before starting this job.
* Patients with medical conditions like renal or cardiovascular diseases.
* Individuals with known allergies or contraindications to study supplements.

Primary outcomes:
measure: Effects of petroleum compounds on psychological health and cognitive functions of petrol station workers in Assiut
timeFrame: 1 year
measure: To explore the relation between the level of petroleum hydrocarbon metabolites and the severity of psychological heath and cognitive functions disturbance of petrol station workers
timeFrame: 1 year
measure: To explore the role of supplements with whey protein in ameliorating these effects
timeFrame: 1 year
Secondary outcomes:
measure: To assess the relationship between the psychological effects, cognitive functions, and nutritional status of petroleum station workers
timeFrame: 1 year
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of medicine
state: Assiut University
Study officials:
affiliation: Assiut University
name: Safaa M George, professor
role: STUDY_DIRECTOR
References:
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citation: Gutierrez L, Folch A, Rojas M, Cantero JL, Atienza M, Folch J, Camins A, Ruiz A, Papandreou C, Bullo M. Effects of Nutrition on Cognitive Function in Adults with or without Cognitive Impairment: A Systematic Review of Randomized Controlled Clinical Trials. Nutrients. 2021 Oct 22;13(11):3728. doi: 10.3390/nu13113728.
citation: Sajid Jabbar A, Ali ET. Impact of Petroleum Exposure on Some Hematological Indices, Interleukin-6, and Inflammatory Markers of Workers at Petroleum Stations in Basra City. J Environ Public Health. 2020 Aug 4;2020:7693891. doi: 10.1155/2020/7693891. eCollection 2020.
citation: Kita M, Obara K, Kondo S, Umeda S, Ano Y. Effect of Supplementation of a Whey Peptide Rich in Tryptophan-Tyrosine-Related Peptides on Cognitive Performance in Healthy Adults: A Randomized, Double-Blind, Placebo-Controlled Study. Nutrients. 2018 Jul 13;10(7):899. doi: 10.3390/nu10070899.