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Genetic Markers Associated With Capsaicinoid Supplementation Effects in Overweight and Obesity

18. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Antatt)

100

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / 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.
Kosttilskudd: 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.
Kosttilskudd: Corn starch placebo
Capsules indistinguishable from Capsipro, composed of corn starch, administered twice daily for 16 weeks

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Universidad Autonoma de Baja California

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

22. april 2026

Primær fullføring (Antatt)

26. august 2026

Studiet fullført (Antatt)

23. november 2026

Datoer for studieregistrering

Først innsendt

5. mai 2026

Først innsendt som oppfylte QC-kriteriene

18. mai 2026

Først lagt ut (Faktiske)

22. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 304/2/N/65/7

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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