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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-59
SponsorAutonomous University of Morelos

About this trial

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.

What Participants Will Do

Participants will:

1. Take vitamin C, vitamin E, or both daily, depending on their assigned group 2. 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 3. Provide samples and health information to measure inflammation and neuropeptides , at the beginning of the intervention and at 12 weeks, when the intervention ends.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ascorbic acid (Vitamin C)

    Dietary supplement

    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

  • tocopherol alpha

    Dietary supplement

    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

  • Ascorbic acid + tocopherol alpha

    Combination product

    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

Treatment groups

192 Participants
are divided into 4 treatment groups
Group A: ascorbic acidExperimental treatment 1 intervention
Group B: tocopherol alphaExperimental treatment 1 intervention
Group C: combinationExperimental treatment 1 intervention
Group D: controlNo intervention 0 interventions

Trial outcomes

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.

Time frame
Baseline and 12 weeks after intervention

Secondary outcomes

1

Change in neuropeptide expression levels

Variation in the expression levels of neuropeptides NPY/AgRP and POMC will be assessed as indicators of hypothalamic regulation of appetite and energy balance.

Time frame
Baseline and 12 weeks after intervention

Other outcomes

1

Change in metabolic parameters

Variation in body mass index (BMI), fasting glucose and lipid profile

Time frame
baseline and 12 weeks after intervention

Sponsors and contacts

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