Effectiveness of a Natural Ingredient on Obesity

Study Overview
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Brief Summary
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randomized, placebo-controlled clinical trial, with two parallel branches whose objective is to evaluate the efficacy of the product investigated on blood pressure and fat mass of subjects without pharmacotherapy.

Detailed Description
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The subjects that meet the selection criteria will make a total of five visits to the research laboratory and will carry out the pre-established tests in the protocol. Subsequently, a statistical analysis will be carried out with the variables measured in the study to obtain results.

Official Title
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Randomized Controlled Clinical Trial on the Efficacy of a Natural Ingredient in Obesity in Subjects With a BMI Greater Than 25 kg / cm2

Conditions
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Overweight and Obesity, High Blood Pressure

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: Subjects of both sexes with age between 18-65 years. Subjects with a body mass index greater than 25 and less than 35. Volunteers capable of understanding the clinical study and willing to comply with the procedures and requirements of the study. Exclusion Criteria: Subjects under treatment that may affect body weight. Subjects with acute diseases. Volunteers with a history or presence of chronic pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunological, dermatological, urological, neurological, psychiatric, cardiovascular or pathology or malignant tumor disease. Subjects undergoing major surgery in the last 3 months. Subjects who quit smoking in the last 6 months or who intend to quit during the study. Subjects with allergies or eating disorders. Volunteers who are participating in another study that includes blood draws or dietary intervention. Pregnant or breastfeeding woman. Subjects whose condition does not make them eligible for the study, according to the researcher.

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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group (Lippia citriodora + sabdariffa)<br>Consumption for 84 days of Lippia citriodora 325 mg + Hibiscus sabdariffa 175 mg. Two capsules per day will be consumed thirty minutes before breakfast orally for 84 days. | Dietary Supplement: dietary supplement consumption<br>* Consumption of the product under study for 84 days, plecebo or experimental product<br>|
| Placebo Comparator: control group Placebo (sucrose)<br>Consumption for 84 days of Lippia citriodora 325 mg + Hibiscus sabdariffa 175 mg or Placebo (sucrose) Two capsules per day will be consumed thirty minutes before breakfast orally for 84 days. | Dietary Supplement: dietary supplement consumption<br>* Consumption of the product under study for 84 days, plecebo or experimental product<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total fat mass | Dual X-ray absorptiometry (DEXA), measured in grams. | From baseline to 84 days | 
| Fat mass in torso | Dual X-ray absorptiometry (DEXA), measured in grams. | From baseline to 84 days | 
| Fat mass in lower limbs | Dual X-ray absorptiometry (DEXA), measured in grams. | From baseline to 84 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fat mass | Bioimpedancetry, in grams. | Time Frame: A record of body composition will be made five times during the 84 days of consumption. Measures will be taken at baseline, at 14 days, 28, 56 and 84 days. For this we will use a TANITA. | 
| Muscle mass | Bioimpedancetry, in grams. | Time Frame: A record of body composition will be made five times during the 84 days of consumption. Measures will be taken at baseline, at 14 days, 28, 56 and 84 days. For this we will use a TANITA. | 
| Percentage of fat mass | Bioimpedancetry. | Time Frame: A record of body composition will be made five times during the 84 days of consumption. Measures will be taken at baseline, at 14 days, 28, 56 and 84 days. For this we will use a TANITA. | 
| blood samples: Glucidal metabolism and lipid metabolism. | BASIC GLUCEMIA, TOTAL CHOLESTEROL, HDL CHOLESTEROL, LDL , CHOLESTEROL, TRIGLICERIDS, GLICATED HEMOGLOBIN. It was measured in milligrams per deciliter | Time Frame: Blood samples will be taken twice, once at baseline, at the beginning of the trial and once at the end after 84 days of use. | 
| Subjective sensation of product consumption | 5-point hedonic scale. There are five points, being 1 I do not like and 5 I like it a lot. A scale will be passed through paper. | Time Frame: Subjects will complete the hedonic scale four times. at 14, 28, 56 and 84 days of consumption of the product under study. | 
| physical activity | MEASURED WITH ACTIGRAPH wGT3X-BT | Time Frame: An accelerometer will be placed twice on the subjects. The first time at baseline and the second after taking 84 days of consumption of the product under study | 
| 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) | Hematological samples were taken before (day 0) and after consumption of the product (day 84) both in the control group and in the experimental group. | 
| Weight | measured in Kg. | Time Frame: A record of body composition will be made five times during the 84 days of consumption. Measures will be taken at baseline, at 14 days, 28, 56 and 84 days. For these determinations we will use a scale (SECA). | 
| Height | Measured in cm. | Time Frame: A record of body composition will be made five times during the 84 days of consumption. Measures will be taken at baseline, at 14 days, 28, 56 and 84 days. For these determinations we will use a scale (SECA). |