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Genetic Markers Associated With Capsaicinoid Supplementation Effects in Overweight and Obesity

18. maj 2026 opdateret af: Yesenia Guadalupe Martinez Acevis, Universidad Autonoma de Baja California

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

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.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

100

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Mexico
    • Estado de Baja California
      • Tijuana, Estado de Baja California, Mexico
        • Universidad Autonoma de Baja California

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Capsaicin supplementation (Capsipro)
Participants assigned to this group will receive capsaicin supplementation. The dose will consist of two oral capsules per day, each containing 100 mg and standardized to 2% capsaicin, administered for 16 weeks.
Kosttilskud: Capsipro supplementation
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.
Placebo komparator: Corn starch placebo
Participants assigned to this group will receive two oral capsules per day of a corn starch-based placebo, identical in appearance to the active treatment, administered for 16 weeks.
Kosttilskud: Corn starch placebo
Capsules indistinguishable from Capsipro, composed of corn starch, administered twice daily for 16 weeks

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in body fat percentage
Tidsramme: Baseline to 16 weeks
Body fat percentage will be assessed using standardized body composition analysis methods to evaluate changes following capsaicinoid supplementation.
Baseline to 16 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in appetite
Tidsramme: 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.
Baseline to 16 weeks
Change in body weight
Tidsramme: Baseline to 16 weeks
Baseline to 16 weeks
Concentration of fasting glucose, HDL, LDL, triglycerides, and other metabolic biomarkers
Tidsramme: Baseline to 16 weeks
Fasting glucose, HDL, LDL, triglycerides and other metabolic biomarkers will be assessed through blood sample analysis.
Baseline to 16 weeks
Concentration of C-reactive protein (CRP) and other inflammatory biomarkers
Tidsramme: Baseline to 16 weeks
Inflammatory biomarkers, including C-reactive protein (CRP) and other inflammatory indicators, will be assessed through blood sample analysis.
Baseline to 16 weeks
Genetic Risk Score for Capsaicinoid Response
Tidsramme: 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.
Baseline to 16 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Universidad Autonoma de Baja California

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

22. april 2026

Primær færdiggørelse (Anslået)

26. august 2026

Studieafslutning (Anslået)

23. november 2026

Datoer for studieregistrering

Først indsendt

5. maj 2026

Først indsendt, der opfyldte QC-kriterier

18. maj 2026

Først opslået (Faktiske)

22. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 304/2/N/65/7

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Individual participant data will not be shared with other researchers. The information collected during the study will be used exclusively for the purposes of the present research and will be analyzed in aggregate form. Confidentiality of the data will be ensured through anonymization and compliance with applicable ethical guidelines and data protection regulations.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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