NCT05857306

Effect of Olvanil Supplementation on Clinical, Biochemical and Anthropometric Parameters in Obese Adults

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: University of Guadalajara · Academic / Other
• Sex: All
• Age: 25 Years – 59 Years
• Healthy volunteers: Accepted

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.

Conditions

• Obesity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Olvanil	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
DIETARY_SUPPLEMENT	Placebo	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

Timeline

• Start date: 2023-02-20
• Primary completion: 2023-07-31
• Completion: 2023-07-31
• First posted: 2023-05-12
• Last updated: 2023-05-12

Locations

2 sites across 1 country: Mexico