Effectiveness of a Natural Ingredient on Obesity

Overweight and Obesity Clinical Trial

— (RACO)  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04105192
• Other study ID #: UCAMCFE-0010
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: November 25, 2019

Study information

• Verified date: March 2020
• Source: Universidad Católica San Antonio de Murcia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: November 25, 2019
• Est. primary completion date: November 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• High Blood Pressure
• Hypertension
• Obesity
• Overweight
• Overweight and Obesity

Intervention

Dietary Supplement:
• dietary supplement consumption
Consumption of the product under study for 84 days, plecebo or experimental product

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	Total fat mass	Dual X-ray absorptiometry (DEXA), measured in grams.	From baseline to 84 days
Primary	Fat mass in torso	Dual X-ray absorptiometry (DEXA), measured in grams.	From baseline to 84 days
Primary	Fat mass in lower limbs	Dual X-ray absorptiometry (DEXA), measured in grams.	From baseline to 84 days
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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
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)	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.
Secondary	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).
Secondary	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).