Overweight and Obesity
Conditions
Keywords
Obesity, Nutrigenomics, Capsaicinoids, Genetics
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTCapsipro 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.
DIETARY_SUPPLEMENTCorn starch placebo
Capsules indistinguishable from Capsipro, composed of corn starch, administered twice daily for 16 weeks
Sponsors
Universidad Autonoma de Baja California
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
25 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in body fat percentage | Baseline to 16 weeks | Body fat percentage will be assessed using standardized body composition analysis methods to evaluate changes following capsaicinoid supplementation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in appetite | 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. |
| Change in body weight | Baseline to 16 weeks | — |
| Concentration of fasting glucose, HDL, LDL, triglycerides, and other metabolic biomarkers | Baseline to 16 weeks | Fasting glucose, HDL, LDL, triglycerides and other metabolic biomarkers will be assessed through blood sample analysis. |
| Concentration of C-reactive protein (CRP) and other inflammatory biomarkers | Baseline to 16 weeks | Inflammatory biomarkers, including C-reactive protein (CRP) and other inflammatory indicators, will be assessed through blood sample analysis. |
| Genetic Risk Score for Capsaicinoid Response | 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. |
Countries
Mexico
Outcome results
None listed