Effectiveness of a Natural Ingredient on Appetite Regulation

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Appetite Regulation, Overweight and Obesity

Intervention / Treatment
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* Dietary Supplement: Dietary supplement consumption


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group (Lippia citriodora + sabdariffa)<br>Consumption for 60 days of Lippia citriodora 325 mg + Hibiscus sabdariffa 175 mg. Two capsules per day will be consumed thirty minutes before breakfast orally for 60 days. | Dietary Supplement: Dietary supplement consumption<br>* 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.<br>|
| Placebo Comparator: control group Placebo (sucrose)<br>Two capsules per day will be consumed thirty minutes before breakfast orally for 60 days. | Dietary Supplement: Dietary supplement consumption<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. |