Clinical trial NCT05857306: Effect of Olvanil Supplementation on Clinical, Biochemical and Anthropometric Parameters in Obese Adults
Official title: Effect of Olvanil Supplementation on Clinical, Biochemical and Anthropometric Parameters in Obese Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Keywords: Capsaicin analogs
Olvanil
Anthropometry
Lead sponsor: University of Guadalajara
Sponsor class: OTHER
First posted: 2023-05-12
Enrollment: 56
Sex: ALL
Minimum age (years): 25
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment Double-blind randomized parallel clinical trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Analysis of anthropometric variable (Height)
timeFrame: 8 weeks
measure: Analysis of anthropometric variable (Waist circumference)
timeFrame: 8 weeks
measure: Analysis of anthropometric variable (Body fat percentage)
timeFrame: 8 weeks
measure: Analysis of anthropometric variable (Weight)
timeFrame: 8 weeks
measure: Analysis of anthropometric variable (BMI)
timeFrame: 8 weeks
measure: Analysis of clinic variables (Systolic and diastolic blood pressure)
timeFrame: 8 weeks
measure: Analysis of biochemicals variables (Glucose)
timeFrame: 8 weeks
measure: Analysis of biochemicals variables (Triglycerides)
timeFrame: 8 weeks
measure: Analysis of biochemicals variables (Total cholesterol)
timeFrame: 8 weeks
measure: Analysis of biochemicals variables (High-density lipoprotein)
timeFrame: 8 weeks
measure: Analysis of biochemicals variables (Low-density lipoprotein)
timeFrame: 8 weeks
measure: Analysis of biochemicals variables (Very low-density lipoprotein)
timeFrame: 8 weeks
measure: Analysis of biochemicals variables (Creatinine)
timeFrame: 8 weeks
measure: Analysis of biochemicals variables (Serum bilirubin)
timeFrame: 8 weeks
measure: Analysis of biochemicals variables (Aspartate amino transaminase)
timeFrame: 8 weeks
measure: Analysis of biochemicals variables (Alanine amino transaminase)
timeFrame: 8 weeks
measure: Analysis of biochemicals variables (Gamma glutamyl transpeptidase)
timeFrame: 8 weeks
measure: Analysis of biochemicals variables (Alkaline phosphatase)
timeFrame: 8 weeks
measure: Analysis of biochemicals variables (Urea)
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: University of Guadalajara
state: Jaliscco
city: Guadalajara
country: Mexico
facility: Universidad de Guadalajara
state: Jalisco
Study officials:
References:
citation: 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.
citation: Zheng 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.
citation: Joseph 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.