Genetic Markers Associated With Capsaicinoid Supplementation Effects in Overweight and Obesity

NCT07602361 | Active Not Recruiting DMC

• 1 other identifier: 304/2/N/65/7
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Overweight and Obesity

Keywords

Obesity; Nutrigenomics; Capsaicinoids; Genetics

Outcome Measures

Primary Outcomes (1)

• Change in body fat percentage

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

  Baseline to 16 weeks

Secondary Outcomes (5)

• Change in appetite

  Baseline to 16 weeks

• Change in body weight

  Baseline to 16 weeks

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

  Baseline to 16 weeks

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

  Baseline to 16 weeks

• Genetic Risk Score for Capsaicinoid Response

  Baseline to 16 weeks

Study Arms (2)

Capsaicin supplementation (Capsipro)

ACTIVE COMPARATOR

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.

Dietary Supplement: Capsipro supplementation

Corn starch placebo

PLACEBO COMPARATOR

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.

Dietary Supplement: Corn starch placebo

Interventions

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.

Capsaicin supplementation (Capsipro)

Corn starch placebo DIETARY_SUPPLEMENT

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

Corn starch placebo

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Autonoma de Baja California: lead

Study Sites (1)

Universidad Autónoma de Baja California

Tijuana, Estado de Baja California, Mexico

Location

Related Publications (2)

• Liviero F, Campisi M, Scarpa MC, Mason P, Guarnieri G, Maestrelli P, Pavanello S. Multiple single nucleotide polymorphisms of the transient receptor potential vanilloid 1 (TRPV1) genes associate with cough sensitivity to capsaicin in healthy subjects. Pulm Pharmacol Ther. 2020 Apr;61:101889. doi: 10.1016/j.pupt.2020.101889. Epub 2020 Jan 11.

  PMID: 31935455 BACKGROUND

• Forstenpointner J, Forster M, May D, Hofschulte F, Cascorbi I, Wasner G, Gierthmuhlen J, Baron R. Short Report: TRPV1-polymorphism 1911 A>G alters capsaicin-induced sensory changes in healthy subjects. PLoS One. 2017 Aug 17;12(8):e0183322. doi: 10.1371/journal.pone.0183322. eCollection 2017.

  PMID: 28817717 BACKGROUND

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be randomly assigned to one of two intervention groups: capsaicin supplementation (CAP) or placebo (PLA). The study will be conducted under a double-blind design, in which both participants and researchers will remain unaware of the treatment allocation throughout the entire intervention period.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomly assigned, under a double-blind design, to one of two intervention groups: an experimental group receiving capsaicin (CAP) supplementation and a control group receiving placebo (PLA). The CAP group will consume two daily capsules of 100 mg each, standardized to 2% capsaicin, while the PLA group will receive corn starch capsules indistinguishable in appearance. The intervention will last a total of 16 weeks. Both participants and researchers will remain unaware of treatment allocation throughout the study in order to minimize bias and ensure the validity of the results.

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 22, 2026
• Study Start: April 22, 2026
• Primary Completion (Estimated): August 26, 2026
• Study Completion (Estimated): November 23, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)