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

University of Guadalajara

Status: Enrolling

Conditions: Obesity

Treatments: Dietary Supplement: Olvanil; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05857306

CI-01123

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 estimated patients

Sex: All

Ages: 25 to 59 years old

Volunteers: Accepts Healthy Volunteers

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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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56 participants in 2 patient groups, including a placebo group

Olvanil

Active Comparator group

Treatment:

Dietary Supplement: Olvanil

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo