Effectiveness of a Natural Ingredient on Appetite Regulation

Overweight and Obesity Clinical Trial

— SAC  

Official title:

Randomized Controlled Trial of Efficacy of a Natural Ingredient on Appetite Regulation in Overweight / Obese Patients Grade I

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04345029
• Other study ID #: UCAMCFE-00012
• Status: Completed
• Phase: N/A
• Start date: January 15, 2020
• Est. completion date: June 30, 2020

Study information

• Verified date: April 2020
• Source: Universidad Católica San Antonio de Murcia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Single-center, double-blind, double-crossed, randomized controlled clinical trial with two crossed branches, designed with the objective of evaluating the effect of the investigational product on satiety.

Description:

Subjects who meet the selection criteria will make a total of five visits to the research laboratory and will carry out the tests established in the protocol. Subsequently, a statistical analysis will be performed with the variables measured in the study to obtain results.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 30, 2020
• Est. primary completion date: June 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age 18-65 years.
• Both genders.
• BMI 25-34.9 kg / m2, both inclusive.
• Weight maintained during the last 3 months.
• Smoking subjects or not, but in any case they do not change their nicotinic habits during their participation in the study.
• Absence of disease diagnosed at the start of the study.

Exclusion Criteria:

• Thyroid dysfunction, infections, or with any type of chronic disease (eg, autoimmune, inflammatory).
• History of allergic hypersensitivity or poor tolerance to any component of the products under study.
• Subjects who are performing or intend to carry out any type of diet, low-calorie or not, during the study.
• Participation in another clinical trial in the three months prior to the study.
• Lack of will or inability to comply with clinical trial procedures.
• Pregnant woman.
• Subjects whose condition does not make them eligible for the study according to the researcher's criteria.

Related Conditions & MeSH terms

• Appetite Regulation
• Overweight
• Overweight and Obesity

Intervention

Dietary Supplement:
• Dietary supplement consumption
The experimental product consumption time was 60 days and the control consumption time was 60 days. Each subject must consume both products, with a washing period of 30 days.

Locations

Country	Name	City	State
Spain	Catholic University of Murcia	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Católica San Antonio de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution of appetite sensation	Satiety assessment, measured in eva scale (%)	It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
Primary	Sensation of appetite before intaking the product under investigation	Satiety assessment, measured in eva scale (%)	It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
Primary	Area under the curve of the evolution of the appetite sensation from instant zero ingestion to instant ingestion of 60 minutes	Satiety assessment, measured in eva scale (%)	It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
Primary	Average of the appetite sensation during the 60 minutes after intake of the experimented product	Satiety assessment, measured in eva scale (%)	It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
Primary	Decrease in the sensation of appetite suffering from subjects when consuming the product in experimentation	Satiety assessment, measured in eva scale (%)	It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
Primary	Area under the curve of the evolution of the appetite feeling from the 60 minutes post-intake instantly 240 minutes post-intake.	Satiety assessment, measured in eva scale (%)	It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
Primary	Appetite sensation at 240 minutes post-ingestion and area under the curve of the evolution of appetite feeling from instant zero post-intake to instant 240 minutes post-intake	Satiety assessment, measured in eva scale (%)	It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
Primary	Appetite feeling immediately after ad-libitum food	Satiety assessment, measured in eva scale (%)	It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
Primary	Amount of energy consumed during the ad-libitum meal	Satiety assessment, measured in kcal with the weighing of the food consumed in the ad libitum test	It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
Primary	Satiety quotient (SQ)	Satiety assessment, measured in kcal with the weighing of the food consumed in the ad libitum test	It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
Secondary	Insulinemia	Hormonal analysis, measured in mU/L	It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product. And in the ad libitum test.
Secondary	Leptin	Hormonal analysis, measured in ng/dL	It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product. And in the ad libitum test.
Secondary	Adiponectin	Hormonal analysis, measured in µg/mL	It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product. And in the ad libitum test.
Secondary	Ghrelin (GHRL)	Hormonal analysis, measured in ng/ml	It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product. And in the ad libitum test.
Secondary	Tyrosine Peptide Tyrosine (PYY)	Hormonal analysis, measured in pg/mL	It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product. And in the ad libitum test.
Secondary	Glucagon Like Peptide - 1 (GLP-1)	Hormonal analysis, measured in ng/mL	It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product. And in the ad libitum test.
Secondary	Blood glucose	Glycidic analysis, measured in mg/dL	It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product. And in the ad libitum test.
Secondary	Glycosylated hemoglobin (HBA1c)	Glycidic analysis, measured in %	It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.
Secondary	Peripheral insulin resistance (HOMA-IR)	Glycidic analysis	It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.
Secondary	Total Cholesterol	Lipidic profile, measured in mg/dl	It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.
Secondary	LDL - Cholesterol	Lipidic profile, measured in mg/dl	It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.
Secondary	HDL - Cholesterol	Lipidic profile, measured in mg/dl	It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.
Secondary	Triglycerides	Lipidic profile, measured in mg/dl	It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.
Secondary	Fat mass	Bioimpedance, in Kg. For this we will use a TANITA	It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.
Secondary	Muscle mass	Bioimpedance, in Kg. For this we will use a TANITA	It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.
Secondary	Body mass index	Bioimpedance, in Kg/m2. For this we will use a TANITA	It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.
Secondary	Physical activity	Measured in MET, with Actigraph wGT3X-BT	It will be measured for 3 days before and after the consumption time (60 days) with the experimental product and the placebo product.
Secondary	Gastrointestinal Quality of Life Test	GIQLI	It is measured before and after the consumption time (60 days) with the experimental product and the placebo product.
Secondary	Quality of Life Test	WHOQOL BREF	It is measured before and after the consumption time (60 days) with the experimental product and the placebo product.
Secondary	Liver safety variables	It is a blood test that measures the presence of some enzymes, proteins and bilirubin in the blood, with the aim of determining if there is any alteration in the liver. Enzyme GPT, GOT, Gamma GT, LDH, alkaline phosphatase and bilirubin (UI/L)	It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.