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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04345029
Other study ID # UCAMCFE-00012
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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.
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