Ignite Creation Date:
2025-12-26 @ 4:00 PM
Ignite Modification Date:
2025-12-29 @ 6:29 AM
Study NCT ID:
NCT05857306
Status:
UNKNOWN
Last Update Posted:
2023-05-12
First Post:
2023-02-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Olvanil Supplementation on Clinical, Biochemical and Anthropometric Parameters in Obese Adults
Sponsor:
University of Guadalajara
Organization:
Study Overview
Official Title:
Effect of Olvanil Supplementation on Clinical, Biochemical and Anthropometric Parameters in Obese Adults
Status:
UNKNOWN
Status Verified Date:
2023-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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. 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:
1. Compare the anthropometric parameters at baseline versus final time between the groups.
2. Compare the clinical parameters at baseline versus final time between groups.
3. 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.
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:
1. Compare the anthropometric parameters at baseline versus final time between the groups.
2. Compare the clinical parameters at baseline versus final time between groups.
3. 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: