Clinical trial NCT04345029: Effectiveness of a Natural Ingredient on Appetite Regulation
Official title: Randomized Controlled Trial of Efficacy of a Natural Ingredient on Appetite Regulation in Overweight / Obese Patients Grade I
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appetite Regulation
Overweight and Obesity
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2020-04-14
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evolution of appetite sensation
timeFrame: It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
measure: Sensation of appetite before intaking the product under investigation
timeFrame: It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
measure: Area under the curve of the evolution of the appetite sensation from instant zero ingestion to instant ingestion of 60 minutes
timeFrame: It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
measure: Average of the appetite sensation during the 60 minutes after intake of the experimented product
timeFrame: It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
measure: Decrease in the sensation of appetite suffering from subjects when consuming the product in experimentation
timeFrame: It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
measure: Area under the curve of the evolution of the appetite feeling from the 60 minutes post-intake instantly 240 minutes post-intake.
timeFrame: It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
measure: 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
timeFrame: It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
measure: Appetite feeling immediately after ad-libitum food
timeFrame: It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
measure: Amount of energy consumed during the ad-libitum meal
timeFrame: It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
measure: Satiety quotient (SQ)
timeFrame: It is measured twice, both at the end of taking the product after 60 days (placebo and experimental product)
Secondary outcomes:
measure: Insulinemia
timeFrame: 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.
measure: Leptin
timeFrame: 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.
measure: Adiponectin
timeFrame: 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.
measure: Ghrelin (GHRL)
timeFrame: 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.
measure: Tyrosine Peptide Tyrosine (PYY)
timeFrame: 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.
measure: Glucagon Like Peptide - 1 (GLP-1)
timeFrame: 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.
measure: Blood glucose
timeFrame: 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.
measure: Glycosylated hemoglobin (HBA1c)
timeFrame: It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.
measure: Peripheral insulin resistance (HOMA-IR)
timeFrame: It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.
measure: Total Cholesterol
timeFrame: It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.
measure: LDL - Cholesterol
timeFrame: It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.
measure: HDL - Cholesterol
timeFrame: It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.
measure: Triglycerides
timeFrame: It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.
measure: Fat mass
timeFrame: It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.
measure: Muscle mass
timeFrame: It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.
measure: Body mass index
timeFrame: It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.
measure: Physical activity
timeFrame: It will be measured for 3 days before and after the consumption time (60 days) with the experimental product and the placebo product.
measure: Gastrointestinal Quality of Life Test
timeFrame: It is measured before and after the consumption time (60 days) with the experimental product and the placebo product.
measure: Quality of Life Test
timeFrame: It is measured before and after the consumption time (60 days) with the experimental product and the placebo product.
measure: Liver safety variables
timeFrame: It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Catholic University of Murcia
Study officials:
References: