Overweight and ObesityNCT07602361
Genetic Markers Associated With Capsaicinoid Supplementation Effects in Overweight and Obesity
A study testing Capsipro supplementation in people with Overweight and Obesity, run by Universidad Autonoma de Baja California at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Capsipro supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteMexico
- Study dates
- 22 Apr 2026to 23 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults diagnosed with overweight or obesity within the age range established for the study
- Willingness to participate in the study
- Signed informed consent form
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Universidad Autónoma de Baja California
Tijuana, Estado de Baja California
About this study
Official 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
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.
Read the 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.
- Conditions
- Overweight and Obesity
- Being tested
- Capsipro supplementation, Corn starch placebo
- Keywords
- Obesity, Nutrigenomics, Capsaicinoids, Genetics
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capsipro supplementationDietary 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 placeboDietary supplement
Capsules indistinguishable from Capsipro, composed of corn starch, administered twice daily for 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Corn starch placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body fat percentage
Body fat percentage will be assessed using standardized body composition analysis methods to evaluate changes following capsaicinoid supplementation.
Measured: Baseline to 16 weeks
Secondary outcomes (5)
Change in appetite
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.
Measured: Baseline to 16 weeks
Change in body weight
Measured: Baseline to 16 weeks
Concentration of fasting glucose, HDL, LDL, triglycerides, and other metabolic biomarkers
Fasting glucose, HDL, LDL, triglycerides and other metabolic biomarkers will be assessed through blood sample analysis.
Measured: Baseline to 16 weeks
Concentration of C-reactive protein (CRP) and other inflammatory biomarkers
Inflammatory biomarkers, including C-reactive protein (CRP) and other inflammatory indicators, will be assessed through blood sample analysis.
Measured: Baseline to 16 weeks
Genetic Risk Score for Capsaicinoid Response
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.
Measured: Baseline to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start22 Apr 2026
- Primary completion26 Aug 2026 (estimated)
- Study completion23 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Baja California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yesenia Guadalupe Martinez Acevis, Universidad Autonoma de Baja California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07602361
- Sponsor's protocol ID
- 304/2/N/65/7
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 31935455Forstenpointner 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.
PubMed 28817717
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07602361
- Acronym / sponsor ID
- 304/2/N/65/7
- Conditions
- Overweight and Obesity
- Keywords
- Obesity, Nutrigenomics, Capsaicinoids, Genetics
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universidad Autonoma de Baja CaliforniaUniversity, hospital or other
- Study start
- 22 Apr 2026 (actual)
- Primary completion
- 26 Aug 2026 (estimated)
- Study completion
- 23 Nov 2026 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Capsaicin supplementation (Capsipro) | Active comparator | Dietary Supplement: Capsipro supplementationParticipants 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. |
| Corn starch placebo | Placebo comparator | Dietary Supplement: Corn starch placeboParticipants 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. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adults diagnosed with overweight or obesity within the age range established for the study
- Willingness to participate in the study
- Signed informed consent form
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capsipro supplementationThis 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 supplement | Capsaicin supplementation (Capsipro) |
| Corn starch placeboCapsules indistinguishable from Capsipro, composed of corn starch, administered twice daily for 16 weeks | Dietary supplement | Corn starch placebo |
Primary outcome
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.
5 secondary outcomes
Change in appetite
Time frame: Baseline to 16 weeks
Change in body weight
Time frame: Baseline to 16 weeks
Concentration of fasting glucose, HDL, LDL, triglycerides, and other metabolic biomarkers
Time frame: Baseline to 16 weeks
Concentration of C-reactive protein (CRP) and other inflammatory biomarkers
Time frame: Baseline to 16 weeks
Genetic Risk Score for Capsaicinoid Response
Time frame: Baseline to 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Background: PubMed 31935455Liviero 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.
- Background: PubMed 28817717Forstenpointner 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Capsipro supplementation in people with Overweight and Obesity, run by Universidad Autonoma de Baja California at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body fat percentage (time frame: Baseline to 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07602361, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.