Effects of Petroleum Compounds on Psychological Health and Cognitive Functions

NCT06380998 | Not Yet Recruiting

• 1 other identifier: EPCPHCFAPAEWPSPSWAG
• Study Type: observational
• Target: 196
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Deterioration

Keywords

Petroleum compounds; psychological heath; cognitive funtions

Outcome Measures

Primary Outcomes (3)

• 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)

  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

  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

  1 year

Secondary Outcomes (1)

• To assess the relationship between the psychological effects, cognitive functions, and nutritional status of petroleum station workers

  1 year

Study Arms (1)

petrol station workers

Petrol station workers of 2 years duration and in direct contact with petroleum compounds vapours

Dietary Supplement: whey protien

Interventions

whey protien DIETARY_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

petrol station workers

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Faculty of medicine

Asyut, Assiut University, 71515, Egypt

Location

Related Publications (7)

• 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.

  PMID: 31295842 BACKGROUND

• da 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.

  PMID: 37598813 BACKGROUND

• Furu 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.

  PMID: 31320491 BACKGROUND

• Geraldino 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.

  PMID: 34104483 BACKGROUND

• 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.

  PMID: 34835984 BACKGROUND

• 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.

  PMID: 32831856 BACKGROUND

• 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.

  PMID: 30011836 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

urine samples for BTEX metabolites

Study Officials

• Safaa M George, professor

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Gehad H Eisa, Assi. lectur

CONTACT

+201018602754; gehadhussien552@gmail.com

Doaa Almaz, lectur

CONTACT

+201010790895; Doaa.almaz3784@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assiut University, Faculty of medicine, Forensic medicine and clinical toxicology department, lecturer assistant

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 24, 2024
• Study Start: October 1, 2024
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 24, 2024

Record last verified: 2024-04

Locations

EG (1)