Effect of Tocopherol and Ascorbic Acid on Neuroinflammation Markers Associated With Neuropeptide Expression in the AgRP/NPY and POMC Pathways in Mexican Population With Obesity
1 other identifier
interventional
192
1 country
1
Brief Summary
This clinical trial will determine whether taking ascorbic acid (vitamin C), α-tocopherol (vitamin E), or both together can lower markers of brain inflammation and change the expression of neuropeptides in Mexican adults with obesity. Main Questions The study aims to answer:
- 1.Does vitamin C, vitamin E, or both reduce neuroinflammation?
- 2.Do these supplements change the expression of neuropeptides linked to obesity? Comparison Groups Researchers will compare the effects of vitamin C alone, vitamin E alone, and the combination of both to see if they improve brain health in people with obesity.
- 3.Take vitamin C, vitamin E, or both daily, depending on their assigned group
- 4.Attend clinic visits once every 2 weeks for and tests for checkups and tests for record and report supplement intake so that researchers can monitor and evaluate treatment adherence
- 5.Provide samples and health information to measure inflammation and neuropeptides , at the beginning of the intervention and at 12 weeks, when the intervention ends.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 10, 2026
CompletedFirst Submitted
Initial submission to the registry
August 17, 2026
CompletedFirst Posted
Study publicly available on registry
August 24, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 30, 2027
August 24, 2026
August 1, 2026
5 months
August 17, 2026
August 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
decrese expression of neuroinflammation biomarkers
Variation in the expression levels of pro-inflammatory cytokines (IL-1β, TNF-α, IL-8) and glial activation proteins (GFAP, S100B) will be assessed as indicators of neuroinflammatory processes.
Baseline and 12 weeks after intervention
Secondary Outcomes (1)
Change in neuropeptide expression levels
Baseline and 12 weeks after intervention
Other Outcomes (1)
Change in metabolic parameters
baseline and 12 weeks after intervention
Study Arms (4)
ascorbic acid
EXPERIMENTALParticipants will receive 1000 mg of ascorbic acid orally once daily for 12 weeks.
tocopherol alpha
EXPERIMENTALParticipants will receive 800mg of alpha-tocopherol orally once daily for 12 weeks.
combination
EXPERIMENTALParticipants will receive both 1000 mg of ascorbic acid and 800mg of alpha-tocopherol orally once daily for 12 weeks.
control
NO INTERVENTIONThis group only be the control of basal measures
Interventions
Participants will receive 1000 mg of ascorbic acid orally once daily for 12 weeks. The intervention is administered in tablet form and aims to evaluate the therapeutic effect of ascorbic acid supplementation in the Biomarkers of neuroinflammation and neuropeptide expression
Participants will receive 800 mg of tocopherol orally once daily for 12 weeks. The intervention is administered in tablet form and aims to evaluate the therapeutic effect of tocopherol supplementation in the Biomarkers of neuroinflammation and neuropeptide expression
Participants will receive 1000mg of ascorbic acid + 800 mg of tocopherol orally once daily for 12 weeks. The intervention is administered in tablet form and aims to evaluate the therapeutic effect ofsupplementation in the Biomarkers of neuroinflammation and neuropeptide expression
Eligibility Criteria
You may qualify if:
- Adults aged 40 to 59 years, Mexican men and women.
- Obese group: Body mass index (BMI) \> 30 kg/m²; body fat percentage \> 25% in men and \> 35% in women; waist circumference \> 90 cm in men and \> 80 cm in women.
- Non-obese group: BMI \< 24.9 kg/m²; body fat percentage \< 25% in men and \< 35% in women; waist circumference \< 90 cm in men and \< 80 cm in women.
- Willingness to sign the informed consent form.
You may not qualify if:
- Individuals with renal diseases, hepatic diseases, or those under pharmacological treatment for any condition associated with acute inflammation.
- Individuals currently undergoing treatment for obesity (pharmacological, nutritional, or physical activity programs).
- Individuals taking dietary supplements or multivitamins.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Medical Center, Universidad Autónoma del Estado de Morelos
Cuernavaca, Morelos, 62210, Mexico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ollin C Martínez Ramírez, Ph.D.
UNIVERSIDAD AUTÓNOMA DEL ESTADO DE MORELOS
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Master of Science (M.Sc.) in Nutrition.
Study Record Dates
First Submitted
August 17, 2026
First Posted
August 24, 2026
Study Start
August 10, 2026
Primary Completion (Estimated)
December 30, 2026
Study Completion (Estimated)
August 30, 2027
Last Updated
August 24, 2026
Record last verified: 2026-08