Effect of antioxidants on stress, work fatigue, and metabolic syndrome in employees of a private corporation in Mexico City

ISRCTN	ISRCTN12762846
DOI	https://doi.org/10.1186/ISRCTN12762846
Sponsor	Instituto Politécnico Nacional
Funders	Secretaría de Investigación y Posgrado, Instituto Politécnico Nacional, BioMaussan, Biodesarrollos Valmex SA de CV

Submission date: 04/03/2026
Registration date: 08/04/2026
Last edited: 08/04/2026

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Plain English summary of protocol not provided at time of registration

Contact information

Dr Elvia Pérez Soto
Public, Scientific, Principal investigator

National School of Medicine and Homeopathy, National Polytechnic Institute
Guillermo Massieu Helguera 239
Ciudad de México
07320
Mexico

ORCID ID	0000-0002-5673-0825
Phone	5557296000 ext. 55571
Email	elvperezs@ipn.mx

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Blinded (masking used)
Control	Placebo
Assignment	Parallel
Purpose	Prevention
Scientific title	Effect of Apple polyphenols, carotenoids, and anthocyanins on stress, work fatigue, and metabolic syndrome in employees of a private corporation in Mexico City
Study acronym	BIOSTRESSMET
Study objectives	To evaluate the effect of antioxidant supplements as a preventive and therapeutic strategy against stress, work fatigue, oxidative stress, inflammation and metabolic syndrome in workers of a private corporation subjected to a high workload.
Ethics approval(s)	Approved 06/08/2025, Bioethics Committee of Escuela Nacional de Medicina y Homeopatía-IPN (Guillermo Massieu Helguera # 239, Col. La Escalera., Ciudad de México, 07320, Mexico; +1 5557296000 ext. 55596; cbioetica.enmh@ipn.mx), ref: CBE/002/2025
Health condition(s) or problem(s) studied	Work-related stress, work-related fatigue, and metabolic syndrome
Intervention	Oral administration Dietary supplements Randomisation will be computer-generated (Excel) by an independent researcher. Participants will be randomly allocated into one of four parallel groups. Each group will receive a specific intervention for 6 months, administered twice daily (5 mL in the morning and 5 mL in the evening, after meals) orally. • Group 1: Dietary Supplement 2.0 Marine Algae (40 mg astaxanthin, 13.2 mg fucoxanthin, 84 mg apple polyphenols). • Group 2: Dietary Supplement 2.1 Marine Algae Premium (166 mg anthocyanins, 194.8 mg total xanthophylls, 125 mg apple polyphenols). • Group 3: Dietary Supplement 3.0 Astaxanthin special formula (500 mg/day from Haematococcus pluvialis). • Group 4 (control): Placebo consisting of purified water, citric acid, sorbic acid, allulose, and flavoring. The study will follow a double-blind design, ensuring that neither the investigators nor the participants are aware of the allocation of the intervention.
Intervention type	Supplement
Primary outcome measure(s)	Work-related stress measured using Validated stress assessment questionnaire (IMSS test and Work Stress Questionnaire) at T0 (prior to supplementation), T1 (months after starting supplementation), and T2 (6 months after starting supplementation: end of intervention period) Work-related fatigue measured using Fatigue Severity Scale- Work Adaptation to the Mexican workin population at T0 (prior to supplementation), T1 (months after starting supplementation), and T2 (6 months after starting supplementation: end of intervention period). Hair Cortisol Concentrations measured using Competitive immunoassay at T0 (prior to supplementation), T1 (months after starting supplementation), and T2 (6 months after starting supplementation: end of intervention period)
Key secondary outcome measure(s)	Biochemical markers (glucose, total lipids, total cholesterol, triglycerides, HDL-cholesterol, non HDL cholesterol, LDL-cholesterol, atherogenic index, urea, Blood urea nitrogen, creatinine, uric acid, HbA1c measured using Acredited medical diagnostic laboratory at T0 (prior to supplementation), T1 (months after starting supplementation), and T2 (6 months after starting supplementation: end of intervention period) Inflammatory cytokines (TNF-α, IL-1β, IL-6, IL-10) measured using Enzyme-linked immunoassay (ELISA) at T0 (prior to supplementation), T1 (months after starting supplementation), and T2 (6 months after starting supplementation: end of intervention period). Oxidative stress biomarkers measured using Analytical techniques (Ferric reducing ability of plasma or FRAP assay, lipoperoxidation, nitric oxide and enzymatic activity of catalase) at T0 (prior to supplementation), T1 (months after starting supplementation), and T2 (6 months after starting supplementation: end of intervention period). Gene expression related to metabolism and inflammation (Nrf2/ARE, NFκB, AP1, HNF4, P38 MAPK 1, ACM1,2,3) measured using Real-time PCR at T0 (prior to supplementation), T1 (months after starting supplementation), and T2 (6 months after starting supplementation: end of intervention period).
Completion date	28/11/2025

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	20 Years
Upper age limit	75 Years
Sex	All
Target sample size at registration	120
Total final enrolment	95
Key inclusion criteria	1. Adults aged ≥18 years 2. Male or female workers 3. Full-time employees working on-site at a private corporate office in Mexico City 4. At least 1 year of continuous in-person work prior to study commencement 5. Fixed work shift 6. Minimum of 1 year of work experience 7. Mentally healthy status 8. Body Mass Index (BMI) > 20 kg/m² (WHO classification) 9. Signed informed consent
Key exclusion criteria	1. Presence of neurodegenerative conditions 2. Current pregnancy or lactation 3. Diagnosis of hypothyroidism 4. Psychiatric disorders 5. Dyed hair (to avoid bias in biomarker analysis) 6. Use of alternative dietary supplements prior to study participation
Date of first enrolment	16/05/2025
Date of final enrolment	30/05/2025

Locations

Countries of recruitment

Mexico

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	Yes, anonymized individual participant data will be shared upon reasonable request to the principal investigator, after publication of the main results. Data will include baseline characteristics, primary and secondary outcomes, and biomarker measurements. Access will be granted to qualified researchers for academic purposes only.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Other files			23/03/2026	No	No
Protocol file		19/03/2026	23/03/2026	No	No

Additional files

49139_Protocol_19March2026.pdf: Protocol file
49139_SPIRIT 2025 checklist.pdf: Other files

Editorial Notes

05/03/2026: Study’s existence confirmed by the Bioethics Committee of The National School of Medicine and Homeopathy, Mexico.