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NCT Number: NCT07602361

Genetic Markers Associated With Capsaicinoid Supplementation Effects in Overweight and Obesity

Capsaicinoids, compounds found in chili peppers of the genus Capsicum, are responsible for their spiciness and may have potential benefits in weight control and cardiometabolic health. They act on processes such as appetite regulation, fat burning, inflammation, and metabolism, although their effects vary among individuals, possibly due to genetic factors. In Mexico, where chili consumption is high and obesity is a significant public health problem, it is particularly relevant to study these genetic variations. The proposed research aims to identify genetic markers that can predict the response to capsaicinoid supplementation and thus develop personalized nutritional strategies for the treatment of obesity and its complications.

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Key information

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Autónoma de Baja California

Tijuana, Estado de Baja California, Mexico

About this study

This study is a clinical investigation designed to understand how a natural compound found in chili peppers may influence the health of individuals with excess body weight, and why some people respond better than others to this type of intervention.

In recent years, it has been observed that certain compounds present in foods can affect metabolism-that is, how the body uses energy, regulates appetite, and stores fat. However, not all individuals respond in the same way to these compounds. This suggests that there are individual differences, possibly related to genetics, that may modify their effects.

The study will be conducted with a small group of adults with excess body weight, who will be randomly assigned to one of two groups. One group will receive daily supplementation with capsules containing an active compound derived from chili peppers, while the other group will receive identical capsules without the active ingredient (placebo). Neither the participants nor the researchers will know who receives which treatment during the study, helping to ensure more objective results.

The intervention will last 16 weeks, during which changes in body weight, body composition (such as fat mass), and metabolic health indicators such as blood glucose and lipid levels will be evaluated.

In addition to assessing the overall effects of the supplement, the study also aims to determine whether genetic characteristics can explain why some individuals show better responses than others. This could, in the future, support the development of more personalized dietary strategies tailored to each person's biological needs.

Overall, this research aims to contribute to the understanding of the potential of chili-derived compounds in supporting weight management, while also advancing toward a more personalized approach in nutrition and health.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults diagnosed with overweight or obesity within the age range established for the study
  • Willingness to participate in the study
  • Signed informed consent form

Exclusion criteria

  • History of thyroid or metabolic disorders requiring pharmacological treatment, such as diabetes mellitus or coronary heart disease
  • Pregnant or breastfeeding women
  • Active smokers
  • High alcohol consumption, defined as >20 g/day in women and >40 g/day in men
  • Use of hypocaloric diets or weight-loss medications within the three months prior to study initiation
  • Daily chili consumption or high habitual intake of capsaicinoids
  • Known hypersensitivity to capsaicinoids
  • Gastrointestinal disorders, such as ulcerative colitis or irritable bowel syndrome

Treatment and study plan

Capsipro supplementation

Dietary Supplement

This intervention differs from similar studies due to the use of standardized capsaicin in fixed-dose capsules, rather than chili extracts, whole foods, or non-standardized mixtures. It is also distinguished by a continuous daily administration regimen over 16 weeks, which allows the assessment of sustained effects over time on anthropometric and metabolic parameters under controlled conditions.

Corn starch placebo

Dietary Supplement

Capsules indistinguishable from Capsipro, composed of corn starch, administered twice daily for 16 weeks

Primary outcomes

  1. Change in body fat percentage

    Time frame: Baseline to 16 weeks

    Body fat percentage will be assessed using standardized body composition analysis methods to evaluate changes following capsaicinoid supplementation.

Secondary outcomes

  1. Change in appetite

    Time frame: Baseline to 16 weeks

    Appetite will be assessed using the validated Simplified Nutritional Appetite Questionnaire (SNAQ).

    The SNAQ consists of 4 items with a total score ranging from 4 to 20 points, where higher scores indicate better appetite.

  2. Change in body weight

    Time frame: Baseline to 16 weeks

  3. Concentration of fasting glucose, HDL, LDL, triglycerides, and other metabolic biomarkers

    Time frame: Baseline to 16 weeks

    Fasting glucose, HDL, LDL, triglycerides and other metabolic biomarkers will be assessed through blood sample analysis.

  4. Concentration of C-reactive protein (CRP) and other inflammatory biomarkers

    Time frame: Baseline to 16 weeks

    Inflammatory biomarkers, including C-reactive protein (CRP) and other inflammatory indicators, will be assessed through blood sample analysis.

  5. Genetic Risk Score for Capsaicinoid Response

    Time frame: Baseline to 16 weeks

    A genetic risk score (GRS) will be calculated from genotype data obtained through molecular genetic analysis of blood samples. The score will be based on the presence of risk genotypes in rs4411417 and rs3783541 (GCH1); rs8065080, rs222747, rs224534, rs222749, and rs460716 (TRPV1); rs713598 and rs1726866 (TAS2R38); rs765007 (TAS2R3); rs2234001 (TAS2R4); and rs2234012 (TAS2R5), assuming additive and independent effects across all loci.

    The total score will represent the number of risk alleles/genotypes identified in each participant.

Sponsors and collaborators

Lead sponsor

Universidad Autonoma de Baja California

Other

Registry information

Official study title

Identification of Genetic Markers Associated With the Effects of Capsaicinoid Supplementation on Appetite, Body Composition, Metabolic Profile, and Inflammatory Markers in Individuals With Overweight or Obesity

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 22, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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