Clinical trial NCT04105192: Effectiveness of a Natural Ingredient on Obesity
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
High Blood Pressure
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2019-09-26
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Total fat mass
timeFrame: From baseline to 84 days
measure: Fat mass in torso
timeFrame: From baseline to 84 days
measure: Fat mass in lower limbs
timeFrame: From baseline to 84 days
Secondary outcomes:
measure: Fat mass
timeFrame: 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.
measure: Muscle mass
timeFrame: 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.
measure: Percentage of fat mass
timeFrame: 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.
measure: blood samples: Glucidal metabolism and lipid metabolism.
timeFrame: 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.
measure: Subjective sensation of product consumption
timeFrame: Time Frame: Subjects will complete the hedonic scale four times. at 14, 28, 56 and 84 days of consumption of the product under study.
measure: physical activity
timeFrame: 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
measure: liver safety variables
timeFrame: 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.
measure: Weight
timeFrame: 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).
measure: Height
timeFrame: 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).
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Catholic University of Murcia
Study officials:
References: