Cognitive DeteriorationNCT06380998
Effects of Petroleum Compounds on Psychological Health and Cognitive Functions
An observational study of Cognitive Deterioration, run by Assiut University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Cognitive Deterioration
- What is being tested?
- whey protien
- How many people
- 196 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to 1 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Petrol station workers at Assiut fuel stations with exposure time of 8 continuous hours for at least 2 years
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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.
- Conditions
- Cognitive Deterioration
- Being tested
- whey protien
- Keywords
- Petroleum compounds, psychological heath, cognitive funtions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whey protienDietary supplement
Whey, the supernatant of yogurt and a byproduct of cheese, is rich in protein and consists of β-lactalbumin, α-lactoglobulin, immunogloblin, bovine serum albumin, and other minor proteins. Whey protein is a globally consumed food material and is well known for its health benefits
| Study group | Role | What they receive |
|---|---|---|
| petrol station workers | Petrol station workers of 2 years duration and in direct contact with petroleum compounds vapours Receives: Dietary Supplement: whey protien |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of petroleum compounds on psychological health and cognitive functions of petrol station workers in Assiut
for psychological assessment through symptom check list 90 (revised) and cognitive function through the Mini Mental State Examination (30 points: 25-30: normal; 21-24: mild cognitive impairment; 10-20: moderate; and 0-9: severe) and Wecksler memory scale (higher score indicates better performance, while lower score indicates memory impairment)
Measured: 1 year
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
urinary metabolites for BTEX through GS-MS
Measured: 1 year
To explore the role of supplements with whey protein in ameliorating these effects
20 g of whey protein 3 times per week for 8 weeks will be given to workers with cognitive difficulties
Measured: 1 year
Secondary outcomes (1)
To assess the relationship between the psychological effects, cognitive functions, and nutritional status of petroleum station workers
relationship between nutritional status, psychological symptoms, and cognitive difficulties through statistics
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cognitive DeteriorationStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gehad Hussien Eisa, Assiut University
- Investigators
- Safaa M George, professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06380998
- Sponsor's protocol ID
- EPCPHCFAPAEWPSPSWAG
- Status last verified
- Apr 2024
- First submitted
- 16 Apr 2024
- Last updated
- 24 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ciulla M, Marinelli L, Cacciatore I, Stefano AD. Role of Dietary Supplements in the Management of Parkinson's Disease. Biomolecules. 2019 Jul 10;9(7):271. doi: 10.3390/biom9070271.
PubMed 31295842da Silva AT, Machado RP, Martins ML, Dorneles LEG, Dalmarco EM, da Silva EL, Hinnig PF, Wazlawik E. Whey Protein, Vitamins C and E Decrease Interleukin-10 in Chronic Hemodialysis Patients: A Pioneer, Randomized, Double-Blind Pilot Trial. J Ren Nutr. 2024 Jan;34(1):58-67. doi: 10.1053/j.jrn.2023.08.007. Epub 2023 Aug 19.
PubMed 37598813Furu HM, Sainio M, Hyvarinen HK, Kaukiainen A. Limitations of periodical health examinations in detecting occupational chronic solvent encephalopathy. Occup Environ Med. 2019 Sep;76(9):688-693. doi: 10.1136/oemed-2019-105858. Epub 2019 Jul 18.
PubMed 31320491Geraldino BR, Nunes RFN, Gomes JB, da Poca KS, Giardini I, Silva PVB, Souza HP, Otero UB, Sarpa M. Evaluation of Exposure to Toluene and Xylene in Gasoline Station Workers. Adv Prev Med. 2021 May 20;2021:5553633. doi: 10.1155/2021/5553633. eCollection 2021.
PubMed 34104483Gutierrez 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.
PubMed 34835984Sajid 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.
PubMed 32831856Kita 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.
PubMed 30011836
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06380998
- Acronym / sponsor ID
- EPCPHCFAPAEWPSPSWAG
- Conditions
- Cognitive Deterioration
- Keywords
- Petroleum compounds, psychological heath, cognitive funtions
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 24 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| petrol station workers | – | Dietary Supplement: whey protienPetrol station workers of 2 years duration and in direct contact with petroleum compounds vapours |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Petrol station workers at Assiut fuel stations with exposure time of 8 continuous hours for at least 2 years
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| whey protienWhey, the supernatant of yogurt and a byproduct of cheese, is rich in protein and consists of β-lactalbumin, α-lactoglobulin, immunogloblin, bovine serum albumin, and other minor proteins. Whey protein is a globally consumed food material and is well known for its health benefits | Dietary supplement | petrol station workers |
Primary outcome
Effects of petroleum compounds on psychological health and cognitive functions of petrol station workers in Assiut
Time frame: 1 year
for psychological assessment through symptom check list 90 (revised) and cognitive function through the Mini Mental State Examination (30 points: 25-30: normal; 21-24: mild cognitive impairment; 10-20: moderate; and 0-9: severe) and Wecksler memory scale (higher score indicates better performance, while lower score indicates memory impairment)
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
Time frame: 1 year
urinary metabolites for BTEX through GS-MS
To explore the role of supplements with whey protein in ameliorating these effects
Time frame: 1 year
20 g of whey protein 3 times per week for 8 weeks will be given to workers with cognitive difficulties
1 secondary outcome
To assess the relationship between the psychological effects, cognitive functions, and nutritional status of petroleum station workers
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Background: PubMed 31295842Ciulla M, Marinelli L, Cacciatore I, Stefano AD. Role of Dietary Supplements in the Management of Parkinson's Disease. Biomolecules. 2019 Jul 10;9(7):271. doi: 10.3390/biom9070271.
- Background: PubMed 37598813da Silva AT, Machado RP, Martins ML, Dorneles LEG, Dalmarco EM, da Silva EL, Hinnig PF, Wazlawik E. Whey Protein, Vitamins C and E Decrease Interleukin-10 in Chronic Hemodialysis Patients: A Pioneer, Randomized, Double-Blind Pilot Trial. J Ren Nutr. 2024 Jan;34(1):58-67. doi: 10.1053/j.jrn.2023.08.007. Epub 2023 Aug 19.
- Background: PubMed 31320491Furu HM, Sainio M, Hyvarinen HK, Kaukiainen A. Limitations of periodical health examinations in detecting occupational chronic solvent encephalopathy. Occup Environ Med. 2019 Sep;76(9):688-693. doi: 10.1136/oemed-2019-105858. Epub 2019 Jul 18.
- Background: PubMed 34104483Geraldino BR, Nunes RFN, Gomes JB, da Poca KS, Giardini I, Silva PVB, Souza HP, Otero UB, Sarpa M. Evaluation of Exposure to Toluene and Xylene in Gasoline Station Workers. Adv Prev Med. 2021 May 20;2021:5553633. doi: 10.1155/2021/5553633. eCollection 2021.
- Background: PubMed 34835984Gutierrez 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.
- Background: PubMed 32831856Sajid 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.
- Background: PubMed 30011836Kita 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Safaa M George, professor study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Deterioration, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gehad H Eisa, Assi. lectur (+201018602754, gehadhussien552@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of petroleum compounds on psychological health and cognitive functions of petrol station workers in Assiut (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06380998, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024.