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

NCT05857306 | Unknown DMC

• 1 other identifier: CI-01123
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 2

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.

Conditions

Obesity

Keywords

Capsaicin analogs; Olvanil; Anthropometry

Outcome Measures

Primary Outcomes (19)

• Analysis of anthropometric variable (Height)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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

Study Arms (2)

Olvanil

ACTIVE COMPARATOR

Dietary Supplement: Olvanil

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Olvanil DIETARY_SUPPLEMENT

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

Olvanil

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 25 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Guadalajara: lead

Study Sites (2)

University of Guadalajara

Guadalajara, Jaliscco, 44280, Mexico

RECRUITING

Universidad de Guadalajara

Guadalajara, Jalisco, 44100, Mexico

RECRUITING

Related Publications (3)

• 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.

  PMID: 27455231 BACKGROUND

• 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.

  PMID: 28424369 BACKGROUND

• 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.

  PMID: 32578488 BACKGROUND

MeSH Terms

Conditions

Obesity

Interventions

olvanil

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Erika Martinez Lopez, PhD

CONTACT

3310585200; erikamtz27@yahoo.com.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double (Participant, Investigator) Both types of capsules were made and packed in blisters and identical boxes. Every box was identified and tagged with a specific number by an associate researcher who is not involved in the recruitment, attention, or follow-up of the enrolled subjects. Finally, block randomization was the selected technique for this purpose.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Parallel Assignment Double-blind randomized parallel clinical trial

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: May 12, 2023
• Study Start: February 20, 2023
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: May 12, 2023

Record last verified: 2023-05

Locations

ME (2)