Effectiveness of a Natural Ingredient on Appetite Regulation

Universidad Católica San Antonio de Murcia36 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Appetite Regulation Overweight and Obesity

Interventions

Dietary supplement consumptionDIETARY_SUPPLEMENT

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Catholic University of Murcia

Murcia, Spain

Outcomes

Primary Outcomes

Evolution of appetite sensation

Satiety assessment, measured in eva scale (%)

Time frame: It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)

Sensation of appetite before intaking the product under investigation

Satiety assessment, measured in eva scale (%)

Time frame: It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)

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 (%)

Time frame: It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)

Average of the appetite sensation during the 60 minutes after intake of the experimented product

Satiety assessment, measured in eva scale (%)

Time frame: It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)

Decrease in the sensation of appetite suffering from subjects when consuming the product in experimentation

Satiety assessment, measured in eva scale (%)

Time frame: It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)

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 (%)

Time frame: It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)

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

Data from ClinicalTrials.gov

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Secondary Outcomes

Insulinemia

Hormonal analysis, measured in mU/L

Time frame: 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.

Leptin

Hormonal analysis, measured in ng/dL

Time frame: 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.

Adiponectin

Hormonal analysis, measured in µg/mL

Time frame: 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.

Ghrelin (GHRL)

Hormonal analysis, measured in ng/ml

Time frame: 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.

Tyrosine Peptide Tyrosine (PYY)

Hormonal analysis, measured in pg/mL

Time frame: 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.

Glucagon Like Peptide - 1 (GLP-1)

Hormonal analysis, measured in ng/mL

Time frame: 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.

Blood glucose

Glycidic analysis, measured in mg/dL

Time frame: 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.

Glycosylated hemoglobin (HBA1c)

Glycidic analysis, measured in %

Time frame: It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.

Peripheral insulin resistance (HOMA-IR)

Glycidic analysis

Time frame: It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.

Total Cholesterol

Lipidic profile, measured in mg/dl

Time frame: It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.

LDL - Cholesterol

Lipidic profile, measured in mg/dl

Time frame: It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.

HDL - Cholesterol

Lipidic profile, measured in mg/dl

Time frame: It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.

Triglycerides

Lipidic profile, measured in mg/dl

Time frame: It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.

Fat mass

Bioimpedance, in Kg. For this we will use a TANITA

Time frame: It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.

Muscle mass

Bioimpedance, in Kg. For this we will use a TANITA

Time frame: It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.

Body mass index

Bioimpedance, in Kg/m2. For this we will use a TANITA

Time frame: It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.

Physical activity

Measured in MET, with Actigraph wGT3X-BT

Time frame: It will be measured for 3 days before and after the consumption time (60 days) with the experimental product and the placebo product.

Gastrointestinal Quality of Life Test

GIQLI

Time frame: It is measured before and after the consumption time (60 days) with the experimental product and the placebo product.

Quality of Life Test

WHOQOL BREF

Time frame: It is measured before and after the consumption time (60 days) with the experimental product and the placebo product.

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)

Time frame: It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.