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

Last updated: May 10, 2023
Sponsor: University of Guadalajara
Overall Status: Active - Recruiting

Phase

N/A

Condition

Obesity

Diabetes Prevention

Treatment

Olvanil

Placebo

Clinical Study ID

NCT05857306
CI-01123
  • Ages 25-59
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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

Exclusion

Exclusion Criteria:

  • 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

Study Design

Total Participants: 56
Treatment Group(s): 2
Primary Treatment: Olvanil
Phase:
Study Start date:
February 20, 2023
Estimated Completion Date:
July 31, 2023

Study 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.

Connect with a study center

  • University of Guadalajara

    Guadalajara, Jaliscco 44280
    Mexico

    Active - Recruiting

  • Universidad de Guadalajara

    Guadalajara, Jalisco 44100
    Mexico

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.