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OpenTrials
Completed

NCT Number: NCT04105192

Effectiveness of a Natural Ingredient on Obesity

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.

Completed

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Key information

Conditions

Overweight and Obesity Body Weight Cardiovascular Diseases High Blood Pressure Hypertension Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Catholic University of Murcia

Murcia, 30107, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dietary supplement consumption

Dietary Supplement

Consumption of the product under study for 84 days, plecebo or experimental product

Primary outcomes

  1. Total fat mass

    Time frame: From baseline to 84 days

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

  2. Fat mass in torso

    Time frame: From baseline to 84 days

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

  3. Fat mass in lower limbs

    Time frame: From baseline to 84 days

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

Secondary outcomes

  1. Fat mass

    Time frame: 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.

    Bioimpedancetry, in grams.

  2. Muscle mass

    Time frame: 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.

    Bioimpedancetry, in grams.

  3. Percentage of fat mass

    Time frame: 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.

    Bioimpedancetry.

  4. blood samples: Glucidal metabolism and lipid metabolism.

    Time frame: 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.

    BASIC GLUCEMIA, TOTAL CHOLESTEROL, HDL CHOLESTEROL, LDL , CHOLESTEROL, TRIGLICERIDS, GLICATED HEMOGLOBIN. It was measured in milligrams per deciliter

  5. Subjective sensation of product consumption

    Time frame: Time Frame: Subjects will complete the hedonic scale four times. at 14, 28, 56 and 84 days of consumption of the product under study.

    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.

  6. physical activity

    Time frame: 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

    MEASURED WITH ACTIGRAPH wGT3X-BT

  7. liver safety variables

    Time frame: 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.

    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)

  8. Weight

    Time frame: 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).

    measured in Kg.

  9. Height

    Time frame: 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).

    Measured in cm.

Sponsors and collaborators

Lead sponsor

Universidad Católica San Antonio de Murcia

Other

Registry information

Official study title

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

Acronym: (RACO)

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 26, 2019
Registry last updated
Apr 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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