ObesityNCT05857306
Effect of Olvanil Supplementation on Clinical, Biochemical and Anthropometric Parameters in Obese Adults
A study testing Olvanil in people with Obesity, run by University of Guadalajara at 2 sites in Mexico.
Trial summary
Capsaicinoids are defined as alkaloid compounds of the Capsicum genus, they are characterised by the pungent flavor of chili. About the Capsicum genus, there are more than 20 known compounds, including dihydrocapsaicin, nordihydrocapsaicin, homodihydrocapsaicin and homocapsaicin. Read more about this study
- Who is it for?
- Ages 25 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Olvanil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 2 sitesMexico
- Study dates
- 20 Feb 2023to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 25-59 years of age
- Both sexes
- Subjects who agree to participate in the study and all signed informed consent
- BMI 30 kg/m2 - 39.9 kg/m2
Who cannot join
- Currently consuming any of the following drugs: NSAIDs, anticoagulants, hypoglycemic, oR hypolipemic drugs
- Diagnosed autoimmune diseases
- Diagnosed cancer
- Pregnancy and breastfeeding
- Suffering from gastritis and hemorrhoids
- Subjects who wish to abandon the study
Trial locations and contacts
2 sites in 1 country.
Mexico2 sites, 2 recruiting
- Recruiting
University of Guadalajara
Guadalajara, Jaliscco, 44280
ERIKA MARTINEZ-LOPEZ, PhD, +52(33)10585200 ext. 33644, erikamtz27@yahoo.com.mx
- Recruiting
Universidad de Guadalajara
Guadalajara, Jalisco, 44100
Erika Martinez Lopez, PhD, erikamtz27@gmail.com
About this study
Capsaicinoids are defined as alkaloid compounds of the Capsicum genus, they are characterised by the pungent flavor of chili. About the Capsicum genus, there are more than 20 known compounds, including dihydrocapsaicin, nordihydrocapsaicin, homodihydrocapsaicin and homocapsaicin. Capsaicin is the most popular compound in the biotechnological food industries. Recent studies has demonstrated the benefits of capsaicin in weight loss, however, the use of this molecule is limited given its high pungent capacity. Pungency develops due to the high affinity of capsaicin for the transient vanilloid potential receptor type 1 (TRPV1), which is primarily responsible for the transmission of pain. In order to eliminate pungency, capsaicin analogs have been developed, such as olvanil, this can become an alternative for its biotechnological and pharmaceutical purposes as an antiobesogenic treatment.
Read the detailed description
A total of 56 subjects will be invited to be enrolled in a study approaching the properties of a capsaicin analog: olvanil, along with nutritional guidance.
This double blind, randomized, parallel clinical trial will consist in a 8-week intervention with recurrent visits every 4 weeks. In every visit, all subjects will undergo a body composition analysis as well as blood tests.
This study proposes three objectives for reaching a further understanding of the effects of olvanil:
- Compare the anthropometric parameters at baseline versus final time between the groups.
- Compare the clinical parameters at baseline versus final time between groups.
- Compare the concentrations of the biochemical parameters at baseline versus final time between the groups.
Once the project is finished, the research strategies for new studies will be improved. In the same way, the application of the knowledge generated in it will be encouraged towards the health care of patients with obesity who could attend our service on future occasions. Finally, we would disseminate the knowledge generated in our institutional community, which would increase the impact of the project.
- Conditions
- Obesity
- Being tested
- Olvanil, Placebo
- Keywords
- Capsaicin analogs, Olvanil, Anthropometry
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlvanilDietary supplement
Nutritional recommendation along with 4 mg Olvanil (1 capsule daily)
Subects within the Intervention group will be provided with a nutritional recommendation along with Olvanil capsules. Subjects will be asked to consume one capsule per day. Every capsule contains: 4 mg Olvanil and 255 mg soy lecithin as excipient
PlaceboDietary supplement
Nutritional recommendation along with 255 mg soy lecithin (1 capsule daily)
Subects within the placebo group will be provided with a nutritional recommendation along with placebo capsules. Subjects will be asked to consume one capsule per day. Every capsule contains: 255 mg soy lecithin
| Study group | Role | What they receive |
|---|---|---|
| Olvanil | Active comparator | Not described Receives: Dietary Supplement: Olvanil |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of anthropometric variable (Height)
The measure will be performe without shoes, and an Height measurement will be determine by a stadiometer and represented in meters.
Measured: 8 weeks
Analysis of anthropometric variable (Waist circumference)
The measure will be performe with light clothes. Waist circumference (WC) represented in centimeters was measured using a Lufkin Executive® Thinline 2-mm measuring tape.
Measured: 8 weeks
Analysis of anthropometric variable (Body fat percentage)
The measure will be performe without shoes, with light clothes. Tetrapolar body electrical bioimpedance will be use to assess body fat percentage using InBody 370 and RJL Quantum V.
Measured: 8 weeks
Analysis of anthropometric variable (Weight)
The measure will be performe without shoes, with light clothes and represented in kilograms Tetrapolar body electrical bioimpedance will be use to assess weight using InBody 370.
Measured: 8 weeks
Analysis of anthropometric variable (BMI)
BMI will be calculate as weight in kilograms divided by height in square meters (kg/m2).
Measured: 8 weeks
Analysis of clinic variables (Systolic and diastolic blood pressure)
The measurement of systolic and diastolic blood pressure will be carry out with a OMRON wireless upper arm blood pressure monitor, and represented millimeters of mercury (mmHg)
Measured: 8 weeks
Analysis of biochemicals variables (Glucose)
Biochemical measurements at baseline and after 8 weeks supplementation Blood samples will be taken after 8 to 10 h of fasting and then centrifuged to obtain the serum, which will be frozen at -80 °C.
- Glucose (Glu) mg/dL
Will be carry out by dry chemistry using a Vitros 350 Analyzer.
Measured: 8 weeks
Analysis of biochemicals variables (Triglycerides)
Biochemical measurements at baseline and after 8 weeks supplementation Blood samples will be taken after 8 to 10 h of fasting and then centrifuged to obtain the serum, which will be frozen at -80 °C.
Determinations of:
- Triglycerides (TG) mg/dL,
Will be carry out by dry chemistry using a Vitros 350 Analyzer.
Measured: 8 weeks
Analysis of biochemicals variables (Total cholesterol)
Biochemical measurements at baseline and after 8 weeks supplementation Blood samples will be taken after 8 to 10 h of fasting and then centrifuged to obtain the serum, which will be frozen at -80 °C.
Determinations of:
- Total cholesterol (TC) mg/dL,
Will be carry out by dry chemistry using a Vitros 350 Analyzer.
Measured: 8 weeks
Analysis of biochemicals variables (High-density lipoprotein)
Biochemical measurements at baseline and after 8 weeks supplementation Blood samples will be taken after 8 to 10 h of fasting and then centrifuged to obtain the serum, which will be frozen at -80 °C.
Determinations of:
- High-density lipoprotein (HDL) mg/dL,
Will be carry out by dry chemistry using a Vitros 350 Analyzer.
Measured: 8 weeks
Analysis of biochemicals variables (Low-density lipoprotein)
Biochemical measurements at baseline and after 8 weeks supplementation Blood samples will be taken after 8 to 10 h of fasting and then centrifuged to obtain the serum, which will be frozen at -80 °C.
Determinations of:
- Low-density lipoprotein (LDL) mg/dL,
Will be carry out by dry chemistry using a Vitros 350 Analyzer.
Measured: 8 weeks
Analysis of biochemicals variables (Very low-density lipoprotein)
Biochemical measurements at baseline and after 8 weeks supplementation Blood samples will be taken after 8 to 10 h of fasting and then centrifuged to obtain the serum, which will be frozen at -80 °C.
Determinations of:
- Very low-density lipoprotein (VLDL) mg/dL, will be carry out by dry chemistry using a Vitros 350 Analyzer.
Measured: 8 weeks
Analysis of biochemicals variables (Creatinine)
Biochemical measurements at baseline and after 8 weeks supplementation Blood samples will be taken after 8 to 10 h of fasting and then centrifuged to obtain the serum, which will be frozen at -80 °C.
Determinations of:
- Creatinine (mg/dL), will be carry out by dry chemistry using a Vitros 350 Analyzer.
Measured: 8 weeks
Analysis of biochemicals variables (Serum bilirubin)
Biochemical measurements at baseline and after 8 weeks supplementation Blood samples will be taken after 8 to 10 h of fasting and then centrifuged to obtain the serum, which will be frozen at -80 °C.
Determinations of:
- Serum bilirubin (mg/dL), will be carry out by dry chemistry using a Vitros 350 Analyzer.
Measured: 8 weeks
Analysis of biochemicals variables (Aspartate amino transaminase)
Biochemical measurements at baseline and after 8 weeks supplementation Blood samples will be taken after 8 to 10 h of fasting and then centrifuged to obtain the serum, which will be frozen at -80 °C.
Determinations of:
- Aspartate amino transaminase (U/L), will be carry out by dry chemistry using a Vitros 350 Analyzer.
Measured: 8 weeks
Analysis of biochemicals variables (Alanine amino transaminase)
Biochemical measurements at baseline and after 8 weeks supplementation Blood samples will be taken after 8 to 10 h of fasting and then centrifuged to obtain the serum, which will be frozen at -80 °C.
Determinations of:
- Alanine amino transaminase (U/L) will be carry out by dry chemistry using a Vitros 350 Analyzer.
Measured: 8 weeks
Analysis of biochemicals variables (Gamma glutamyl transpeptidase)
Biochemical measurements at baseline and after 8 weeks supplementation Blood samples will be taken after 8 to 10 h of fasting and then centrifuged to obtain the serum, which will be frozen at -80 °C.
Determinations of:
- Gamma glutamyl transpeptidase (U/L), will be carry out by dry chemistry using a Vitros 350 Analyzer.
Measured: 8 weeks
Analysis of biochemicals variables (Alkaline phosphatase)
Biochemical measurements at baseline and after 8 weeks supplementation Blood samples will be taken after 8 to 10 h of fasting and then centrifuged to obtain the serum, which will be frozen at -80 °C.
Determinations of:
- Alkaline phosphatase (U/L) will be carry out by dry chemistry using a Vitros 350 Analyzer.
Measured: 8 weeks
Analysis of biochemicals variables (Urea)
Biochemical measurements at baseline and after 8 weeks supplementation Blood samples will be taken after 8 to 10 h of fasting and then centrifuged to obtain the serum, which will be frozen at -80 °C.
Determinations of:
- Urea (mg/dL) will be carry out by dry chemistry using a Vitros 350 Analyzer.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start20 Feb 2023
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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
- Parallel Assignment Double-blind randomized parallel clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Guadalajara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ERIKA MARTINEZ-LOPEZ, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05857306
- Sponsor's protocol ID
- CI-01123
- Status last verified
- May 2023
- First submitted
- 20 Feb 2023
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Basith S, Cui M, Hong S, Choi S. Harnessing the Therapeutic Potential of Capsaicin and Its Analogues in Pain and Other Diseases. Molecules. 2016 Jul 23;21(8):966. doi: 10.3390/molecules21080966.
PubMed 27455231Zheng J, Zheng S, Feng Q, Zhang Q, Xiao X. Dietary capsaicin and its anti-obesity potency: from mechanism to clinical implications. Biosci Rep. 2017 May 11;37(3):BSR20170286. doi: 10.1042/BSR20170286. Print 2017 Jun 30.
PubMed 28424369Joseph MSc A, John PhD F, Thomas MSc JV, Sivadasan SDP, Maliakel PhD B, Mohan PhD R, I M K. Influence of a Novel Food-Grade Formulation of Red Chili Extract (Capsicum annum) on Overweight Subjects: Randomized, Double-Blinded, Placebo-Controlled Study. J Diet Suppl. 2021;18(4):387-405. doi: 10.1080/19390211.2020.1780363. Epub 2020 Jun 24.
PubMed 32578488
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Olvanil Supplementation on Clinical, Biochemical and Anthropometric Parameters in Obese Adults
- ClinicalTrials.gov ID
- NCT05857306
- Acronym / sponsor ID
- CI-01123
- Conditions
- Obesity
- Keywords
- Capsaicin analogs, Olvanil, Anthropometry
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- University of GuadalajaraUniversity, hospital or other
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 12 May 2023 (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 are defined as alkaloid compounds of the Capsicum genus, they are characterised by the pungent flavor of chili. About the Capsicum genus, there are more than 20 known compounds, including dihydrocapsaicin, nordihydrocapsaicin, homodihydrocapsaicin and homocapsaicin. Capsaicin is the most popular compound in the biotechnological food industries. Recent studies has demonstrated the benefits of capsaicin in weight loss, however, the use of this molecule is limited given its high pungent capacity. Pungency develops due to the high affinity of capsaicin for the transient vanilloid potential receptor type 1 (TRPV1), which is primarily responsible for the transmission of pain. In order to eliminate pungency, capsaicin analogs have been developed, such as olvanil, this can become an alternative for its biotechnological and pharmaceutical purposes as an antiobesogenic treatment.
Detailed description
A total of 56 subjects will be invited to be enrolled in a study approaching the properties of a capsaicin analog: olvanil, along with nutritional guidance.
This double blind, randomized, parallel clinical trial will consist in a 8-week intervention with recurrent visits every 4 weeks. In every visit, all subjects will undergo a body composition analysis as well as blood tests.
This study proposes three objectives for reaching a further understanding of the effects of olvanil:
- Compare the anthropometric parameters at baseline versus final time between the groups.
- Compare the clinical parameters at baseline versus final time between groups.
- Compare the concentrations of the biochemical parameters at baseline versus final time between the groups.
Once the project is finished, the research strategies for new studies will be improved. In the same way, the application of the knowledge generated in it will be encouraged towards the health care of patients with obesity who could attend our service on future occasions. Finally, we would disseminate the knowledge generated in our institutional community, which would increase the impact of the project.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Parallel Assignment Double-blind randomized parallel clinical trial
| Arm | Type | Receives |
|---|---|---|
| Olvanil | Active comparator | Dietary Supplement: Olvanil |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 25 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 25-59 years of age
- Both sexes
- Subjects who agree to participate in the study and all signed informed consent
- BMI 30 kg/m2 - 39.9 kg/m2
Key exclusion criteria (6 listed)
- Currently consuming any of the following drugs: NSAIDs, anticoagulants, hypoglycemic, oR hypolipemic drugs
- Diagnosed autoimmune diseases
- Diagnosed cancer
- Pregnancy and breastfeeding
- Suffering from gastritis and hemorrhoids
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 |
|---|---|---|
| OlvanilNutritional recommendation along with 4 mg Olvanil (1 capsule daily) Subects within the Intervention group will be provided with a nutritional recommendation along with Olvanil capsules. Subjects will be asked to consume one capsule per day. Every capsule contains: 4 mg Olvanil and 255 mg soy lecithin as excipient | Dietary supplement | Olvanil |
| PlaceboNutritional recommendation along with 255 mg soy lecithin (1 capsule daily) Subects within the placebo group will be provided with a nutritional recommendation along with placebo capsules. Subjects will be asked to consume one capsule per day. Every capsule contains: 255 mg soy lecithin | Dietary supplement | Placebo |
Primary outcome
Analysis of anthropometric variable (Height)
Time frame: 8 weeks
The measure will be performe without shoes, and an Height measurement will be determine by a stadiometer and represented in meters.
Analysis of anthropometric variable (Waist circumference)
Time frame: 8 weeks
The measure will be performe with light clothes. Waist circumference (WC) represented in centimeters was measured using a Lufkin Executive® Thinline 2-mm measuring tape.
Analysis of anthropometric variable (Body fat percentage)
Time frame: 8 weeks
The measure will be performe without shoes, with light clothes. Tetrapolar body electrical bioimpedance will be use to assess body fat percentage using InBody 370 and RJL Quantum V.
Analysis of anthropometric variable (Weight)
Time frame: 8 weeks
The measure will be performe without shoes, with light clothes and represented in kilograms Tetrapolar body electrical bioimpedance will be use to assess weight using InBody 370.
Analysis of anthropometric variable (BMI)
Time frame: 8 weeks
BMI will be calculate as weight in kilograms divided by height in square meters (kg/m2).
Analysis of clinic variables (Systolic and diastolic blood pressure)
Time frame: 8 weeks
The measurement of systolic and diastolic blood pressure will be carry out with a OMRON wireless upper arm blood pressure monitor, and represented millimeters of mercury (mmHg)
Analysis of biochemicals variables (Glucose)
Time frame: 8 weeks
Biochemical measurements at baseline and after 8 weeks supplementation Blood samples will be taken after 8 to 10 h of fasting and then centrifuged to obtain the serum, which will be frozen at -80 °C. - Glucose (Glu) mg/dL Will be carry out by dry chemistry using a Vitros 350 Analyzer.
Analysis of biochemicals variables (Triglycerides)
Time frame: 8 weeks
Biochemical measurements at baseline and after 8 weeks supplementation Blood samples will be taken after 8 to 10 h of fasting and then centrifuged to obtain the serum, which will be frozen at -80 °C. Determinations of: - Triglycerides (TG) mg/dL, Will be carry out by dry chemistry using a Vitros 350 Analyzer.
Analysis of biochemicals variables (Total cholesterol)
Time frame: 8 weeks
Biochemical measurements at baseline and after 8 weeks supplementation Blood samples will be taken after 8 to 10 h of fasting and then centrifuged to obtain the serum, which will be frozen at -80 °C. Determinations of: - Total cholesterol (TC) mg/dL, Will be carry out by dry chemistry using a Vitros 350 Analyzer.
Analysis of biochemicals variables (High-density lipoprotein)
Time frame: 8 weeks
Biochemical measurements at baseline and after 8 weeks supplementation Blood samples will be taken after 8 to 10 h of fasting and then centrifuged to obtain the serum, which will be frozen at -80 °C. Determinations of: - High-density lipoprotein (HDL) mg/dL, Will be carry out by dry chemistry using a Vitros 350 Analyzer.
Analysis of biochemicals variables (Low-density lipoprotein)
Time frame: 8 weeks
Biochemical measurements at baseline and after 8 weeks supplementation Blood samples will be taken after 8 to 10 h of fasting and then centrifuged to obtain the serum, which will be frozen at -80 °C. Determinations of: - Low-density lipoprotein (LDL) mg/dL, Will be carry out by dry chemistry using a Vitros 350 Analyzer.
Analysis of biochemicals variables (Very low-density lipoprotein)
Time frame: 8 weeks
Biochemical measurements at baseline and after 8 weeks supplementation Blood samples will be taken after 8 to 10 h of fasting and then centrifuged to obtain the serum, which will be frozen at -80 °C. Determinations of: - Very low-density lipoprotein (VLDL) mg/dL, will be carry out by dry chemistry using a Vitros 350 Analyzer.
Analysis of biochemicals variables (Creatinine)
Time frame: 8 weeks
Biochemical measurements at baseline and after 8 weeks supplementation Blood samples will be taken after 8 to 10 h of fasting and then centrifuged to obtain the serum, which will be frozen at -80 °C. Determinations of: - Creatinine (mg/dL), will be carry out by dry chemistry using a Vitros 350 Analyzer.
Analysis of biochemicals variables (Serum bilirubin)
Time frame: 8 weeks
Biochemical measurements at baseline and after 8 weeks supplementation Blood samples will be taken after 8 to 10 h of fasting and then centrifuged to obtain the serum, which will be frozen at -80 °C. Determinations of: - Serum bilirubin (mg/dL), will be carry out by dry chemistry using a Vitros 350 Analyzer.
Analysis of biochemicals variables (Aspartate amino transaminase)
Time frame: 8 weeks
Biochemical measurements at baseline and after 8 weeks supplementation Blood samples will be taken after 8 to 10 h of fasting and then centrifuged to obtain the serum, which will be frozen at -80 °C. Determinations of: - Aspartate amino transaminase (U/L), will be carry out by dry chemistry using a Vitros 350 Analyzer.
Analysis of biochemicals variables (Alanine amino transaminase)
Time frame: 8 weeks
Biochemical measurements at baseline and after 8 weeks supplementation Blood samples will be taken after 8 to 10 h of fasting and then centrifuged to obtain the serum, which will be frozen at -80 °C. Determinations of: - Alanine amino transaminase (U/L) will be carry out by dry chemistry using a Vitros 350 Analyzer.
Analysis of biochemicals variables (Gamma glutamyl transpeptidase)
Time frame: 8 weeks
Biochemical measurements at baseline and after 8 weeks supplementation Blood samples will be taken after 8 to 10 h of fasting and then centrifuged to obtain the serum, which will be frozen at -80 °C. Determinations of: - Gamma glutamyl transpeptidase (U/L), will be carry out by dry chemistry using a Vitros 350 Analyzer.
Analysis of biochemicals variables (Alkaline phosphatase)
Time frame: 8 weeks
Biochemical measurements at baseline and after 8 weeks supplementation Blood samples will be taken after 8 to 10 h of fasting and then centrifuged to obtain the serum, which will be frozen at -80 °C. Determinations of: - Alkaline phosphatase (U/L) will be carry out by dry chemistry using a Vitros 350 Analyzer.
Analysis of biochemicals variables (Urea)
Time frame: 8 weeks
Biochemical measurements at baseline and after 8 weeks supplementation Blood samples will be taken after 8 to 10 h of fasting and then centrifuged to obtain the serum, which will be frozen at -80 °C. Determinations of: - Urea (mg/dL) will be carry out by dry chemistry using a Vitros 350 Analyzer.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Background: PubMed 27455231Basith S, Cui M, Hong S, Choi S. Harnessing the Therapeutic Potential of Capsaicin and Its Analogues in Pain and Other Diseases. Molecules. 2016 Jul 23;21(8):966. doi: 10.3390/molecules21080966.
- Background: PubMed 28424369Zheng J, Zheng S, Feng Q, Zhang Q, Xiao X. Dietary capsaicin and its anti-obesity potency: from mechanism to clinical implications. Biosci Rep. 2017 May 11;37(3):BSR20170286. doi: 10.1042/BSR20170286. Print 2017 Jun 30.
- Background: PubMed 32578488Joseph MSc A, John PhD F, Thomas MSc JV, Sivadasan SDP, Maliakel PhD B, Mohan PhD R, I M K. Influence of a Novel Food-Grade Formulation of Red Chili Extract (Capsicum annum) on Overweight Subjects: Randomized, Double-Blinded, Placebo-Controlled Study. J Diet Suppl. 2021;18(4):387-405. doi: 10.1080/19390211.2020.1780363. Epub 2020 Jun 24.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Olvanil in people with Obesity, run by University of Guadalajara at 2 sites 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Erika Martinez Lopez, PhD (3310585200 ext. 34284, erikamtz27@yahoo.com.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of anthropometric variable (Height) (time frame: 8 weeks). The study lists 19 primary outcomes in all. 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 NCT05857306, which also lists 3 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 12 May 2023.