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

May 10, 2023 updated by: ERIKA MARTINEZ-LOPEZ, University of Guadalajara
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.

Study Overview

Status

Recruiting

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Anticipated)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Mexico
    • Jaliscco
      • Guadalajara, Jaliscco, Mexico, 44280
        • Recruiting
        • University of Guadalajara
        • Contact:
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44100
        • Recruiting
        • Universidad de Guadalajara
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
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
Active Comparator: Olvanil
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of anthropometric variable (Height)
Time Frame: 8 weeks
The measure will be performe without shoes, and an Height measurement will be determine by a stadiometer and represented in meters.
8 weeks
Analysis of anthropometric variable (Waist circumference)
Time Frame: 8 weeks
The measure will be performe with light clothes. Waist circumference (WC) represented in centimeters was measured using a Lufkin Executive® Thinline 2-mm measuring tape.
8 weeks
Analysis of anthropometric variable (Body fat percentage)
Time Frame: 8 weeks
The measure will be performe without shoes, with light clothes. Tetrapolar body electrical bioimpedance will be use to assess body fat percentage using InBody 370 and RJL Quantum V.
8 weeks
Analysis of anthropometric variable (Weight)
Time Frame: 8 weeks
The measure will be performe without shoes, with light clothes and represented in kilograms Tetrapolar body electrical bioimpedance will be use to assess weight using InBody 370.
8 weeks
Analysis of anthropometric variable (BMI)
Time Frame: 8 weeks
BMI will be calculate as weight in kilograms divided by height in square meters (kg/m2).
8 weeks
Analysis of clinic variables (Systolic and diastolic blood pressure)
Time Frame: 8 weeks
The measurement of systolic and diastolic blood pressure will be carry out with a OMRON wireless upper arm blood pressure monitor, and represented millimeters of mercury (mmHg)
8 weeks
Analysis of biochemicals variables (Glucose)
Time Frame: 8 weeks

Biochemical measurements at baseline and after 8 weeks supplementation Blood samples will be taken after 8 to 10 h of fasting and then centrifuged to obtain the serum, which will be frozen at -80 °C.

- Glucose (Glu) mg/dL

Will be carry out by dry chemistry using a Vitros 350 Analyzer.
8 weeks
Analysis of biochemicals variables (Triglycerides)
Time Frame: 8 weeks

Biochemical measurements at baseline and after 8 weeks supplementation Blood samples will be taken after 8 to 10 h of fasting and then centrifuged to obtain the serum, which will be frozen at -80 °C.

Determinations of:

- Triglycerides (TG) mg/dL,

Will be carry out by dry chemistry using a Vitros 350 Analyzer.
8 weeks
Analysis of biochemicals variables (Total cholesterol)
Time Frame: 8 weeks

Biochemical measurements at baseline and after 8 weeks supplementation Blood samples will be taken after 8 to 10 h of fasting and then centrifuged to obtain the serum, which will be frozen at -80 °C.

Determinations of:

- Total cholesterol (TC) mg/dL,

Will be carry out by dry chemistry using a Vitros 350 Analyzer.
8 weeks
Analysis of biochemicals variables (High-density lipoprotein)
Time Frame: 8 weeks

Biochemical measurements at baseline and after 8 weeks supplementation Blood samples will be taken after 8 to 10 h of fasting and then centrifuged to obtain the serum, which will be frozen at -80 °C.

Determinations of:

- High-density lipoprotein (HDL) mg/dL,

Will be carry out by dry chemistry using a Vitros 350 Analyzer.
8 weeks
Analysis of biochemicals variables (Low-density lipoprotein)
Time Frame: 8 weeks

Biochemical measurements at baseline and after 8 weeks supplementation Blood samples will be taken after 8 to 10 h of fasting and then centrifuged to obtain the serum, which will be frozen at -80 °C.

Determinations of:

- Low-density lipoprotein (LDL) mg/dL,

Will be carry out by dry chemistry using a Vitros 350 Analyzer.
8 weeks
Analysis of biochemicals variables (Very low-density lipoprotein)
Time Frame: 8 weeks

Biochemical measurements at baseline and after 8 weeks supplementation Blood samples will be taken after 8 to 10 h of fasting and then centrifuged to obtain the serum, which will be frozen at -80 °C.

Determinations of:

- Very low-density lipoprotein (VLDL) mg/dL,

will be carry out by dry chemistry using a Vitros 350 Analyzer.
8 weeks
Analysis of biochemicals variables (Creatinine)
Time Frame: 8 weeks

Biochemical measurements at baseline and after 8 weeks supplementation Blood samples will be taken after 8 to 10 h of fasting and then centrifuged to obtain the serum, which will be frozen at -80 °C.

Determinations of:

- Creatinine (mg/dL),

will be carry out by dry chemistry using a Vitros 350 Analyzer.
8 weeks
Analysis of biochemicals variables (Serum bilirubin)
Time Frame: 8 weeks

Biochemical measurements at baseline and after 8 weeks supplementation Blood samples will be taken after 8 to 10 h of fasting and then centrifuged to obtain the serum, which will be frozen at -80 °C.

Determinations of:

- Serum bilirubin (mg/dL),

will be carry out by dry chemistry using a Vitros 350 Analyzer.
8 weeks
Analysis of biochemicals variables (Aspartate amino transaminase)
Time Frame: 8 weeks

Biochemical measurements at baseline and after 8 weeks supplementation Blood samples will be taken after 8 to 10 h of fasting and then centrifuged to obtain the serum, which will be frozen at -80 °C.

Determinations of:

- Aspartate amino transaminase (U/L),

will be carry out by dry chemistry using a Vitros 350 Analyzer.
8 weeks
Analysis of biochemicals variables (Alanine amino transaminase)
Time Frame: 8 weeks

Biochemical measurements at baseline and after 8 weeks supplementation Blood samples will be taken after 8 to 10 h of fasting and then centrifuged to obtain the serum, which will be frozen at -80 °C.

Determinations of:

- Alanine amino transaminase (U/L)

will be carry out by dry chemistry using a Vitros 350 Analyzer.
8 weeks
Analysis of biochemicals variables (Gamma glutamyl transpeptidase)
Time Frame: 8 weeks

Biochemical measurements at baseline and after 8 weeks supplementation Blood samples will be taken after 8 to 10 h of fasting and then centrifuged to obtain the serum, which will be frozen at -80 °C.

Determinations of:

- Gamma glutamyl transpeptidase (U/L),

will be carry out by dry chemistry using a Vitros 350 Analyzer.
8 weeks
Analysis of biochemicals variables (Alkaline phosphatase)
Time Frame: 8 weeks

Biochemical measurements at baseline and after 8 weeks supplementation Blood samples will be taken after 8 to 10 h of fasting and then centrifuged to obtain the serum, which will be frozen at -80 °C.

Determinations of:

- Alkaline phosphatase (U/L)

will be carry out by dry chemistry using a Vitros 350 Analyzer.
8 weeks
Analysis of biochemicals variables (Urea)
Time Frame: 8 weeks

Biochemical measurements at baseline and after 8 weeks supplementation Blood samples will be taken after 8 to 10 h of fasting and then centrifuged to obtain the serum, which will be frozen at -80 °C.

Determinations of:

- Urea (mg/dL)

will be carry out by dry chemistry using a Vitros 350 Analyzer.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Guadalajara

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2023

Primary Completion (Anticipated)

July 31, 2023

Study Completion (Anticipated)

July 31, 2023

Study Registration Dates

First Submitted

February 20, 2023

First Submitted That Met QC Criteria

May 10, 2023

First Posted (Actual)

May 12, 2023

Study Record Updates

Last Update Posted (Actual)

May 12, 2023

Last Update Submitted That Met QC Criteria

May 10, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CI-01123

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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