Effectiveness of a Natural Ingredient on Appetite Regulation

Not Applicable

Completed

• Conditions: Appetite Regulation; Overweight and Obesity

• Registration Number: NCT04345029
• Lead Sponsor: Universidad Católica San Antonio de Murcia

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2020-01-15
• Status Verified: 2020-04
• Study First Submitted: 2020-04-06
• Study First Submitted QC: 2020-04-09
• Study First Posted: 2020-04-14
• Primary Completion: 2020-06-15
• Study Completion: 2020-06-30
• Last Update Submitted: 2020-10-16
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Decrease in the sensation of appetite suffering from subjects when consuming the product in experimentation	It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)	Satiety assessment, measured in eva scale (%)
Evolution of appetite sensation	It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)	Satiety assessment, measured in eva scale (%)
Area under the curve of the evolution of the appetite sensation from instant zero ingestion to instant ingestion of 60 minutes	It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)	Satiety assessment, measured in eva scale (%)
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	It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)	Satiety assessment, measured in eva scale (%)
Appetite feeling immediately after ad-libitum food	It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)	Satiety assessment, measured in eva scale (%)
Sensation of appetite before intaking the product under investigation	It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)	Satiety assessment, measured in eva scale (%)
Average of the appetite sensation during the 60 minutes after intake of the experimented product	It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)	Satiety assessment, measured in eva scale (%)
Area under the curve of the evolution of the appetite feeling from the 60 minutes post-intake instantly 240 minutes post-intake.	It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)	Satiety assessment, measured in eva scale (%)
Amount of energy consumed during the ad-libitum meal	It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)	Satiety assessment, measured in kcal with the weighing of the food consumed in the ad libitum test
Satiety quotient (SQ)	It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)	Satiety assessment, measured in kcal with the weighing of the food consumed in the ad libitum test

Secondary Outcome Measures

Name	Time	Method
Ghrelin (GHRL)	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.	Hormonal analysis, measured in ng/ml
Adiponectin	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.	Hormonal analysis, measured in µg/mL
HDL - Cholesterol	It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.	Lipidic profile, measured in mg/dl
Insulinemia	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.	Hormonal analysis, measured in mU/L
Leptin	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.	Hormonal analysis, measured in ng/dL
Glucagon Like Peptide - 1 (GLP-1)	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.	Hormonal analysis, measured in ng/mL
Liver safety variables	It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.	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)
Blood glucose	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.	Glycidic analysis, measured in mg/dL
Physical activity	It will be measured for 3 days before and after the consumption time (60 days) with the experimental product and the placebo product.	Measured in MET, with Actigraph wGT3X-BT
Gastrointestinal Quality of Life Test	It is measured before and after the consumption time (60 days) with the experimental product and the placebo product.	GIQLI
Tyrosine Peptide Tyrosine (PYY)	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.	Hormonal analysis, measured in pg/mL
Peripheral insulin resistance (HOMA-IR)	It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.	Glycidic analysis
LDL - Cholesterol	It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.	Lipidic profile, measured in mg/dl
Triglycerides	It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.	Lipidic profile, measured in mg/dl
Body mass index	It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.	Bioimpedance, in Kg/m2. For this we will use a TANITA
Glycosylated hemoglobin (HBA1c)	It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.	Glycidic analysis, measured in %
Total Cholesterol	It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.	Lipidic profile, measured in mg/dl
Fat mass	It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.	Bioimpedance, in Kg. For this we will use a TANITA
Muscle mass	It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.	Bioimpedance, in Kg. For this we will use a TANITA
Quality of Life Test	It is measured before and after the consumption time (60 days) with the experimental product and the placebo product.	WHOQOL BREF

Trial Locations

Locations (1)

Catholic University of Murcia; 🇪🇸 Murcia, Spain