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

Universidad Católica San Antonio de Murcia1 site in 1 country84 target enrollmentMarch 1, 2019

ConditionsOverweight and Obesity High Blood Pressure

Overview

Phase: N/A
Intervention: Not specified
Conditions: Overweight and Obesity
Sponsor: Universidad Católica San Antonio de Murcia
Enrollment: 84
Locations: 1
Primary Endpoint: Fat mass in lower limbs
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Detailed 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.

Registry

clinicaltrials.gov

Start Date

March 1, 2019

End Date

November 25, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Universidad Católica San Antonio de Murcia

Responsible Party

Principal Investigator

Francisco Javier López Román

Principal Investigator

Universidad Católica San Antonio de Murcia

Eligibility Criteria

Inclusion Criteria

•Subjects of both sexes with age between 18-65 years.
•Subjects with a body mass index greater than 25 and less than
•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.

Outcomes

Primary Outcomes

Fat mass in lower limbs

Time Frame: From baseline to 84 days

Dual X-ray absorptiometry (DEXA), measured in grams.

Total fat mass

Time Frame: From baseline to 84 days

Dual X-ray absorptiometry (DEXA), measured in grams.

Fat mass in torso

Time Frame: From baseline to 84 days

Dual X-ray absorptiometry (DEXA), measured in grams.

Secondary Outcomes

blood samples: Glucidal metabolism and lipid metabolism.(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.)
Muscle mass(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.)
physical activity(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)
Fat mass(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(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.)
Subjective sensation of product consumption(Time Frame: Subjects will complete the hedonic scale four times. at 14, 28, 56 and 84 days of consumption of the product under study.)
Height(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).)
liver safety variables(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(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).)