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Effectiveness of a Natural Ingredient on Obesity ((RACO))

Primary Purpose

Overweight and Obesity, High Blood Pressure

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
dietary supplement consumption
Sponsored by
Universidad Católica San Antonio de Murcia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight and Obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Catholic University of Murcia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

experimental group (Lippia citriodora + sabdariffa)

control group Placebo (sucrose)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Total fat mass
Dual X-ray absorptiometry (DEXA), measured in grams.
Fat mass in torso
Dual X-ray absorptiometry (DEXA), measured in grams.
Fat mass in lower limbs
Dual X-ray absorptiometry (DEXA), measured in grams.

Secondary Outcome Measures

Fat mass
Bioimpedancetry, in grams.
Muscle mass
Bioimpedancetry, in grams.
Percentage of fat mass
Bioimpedancetry.
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
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.
physical activity
MEASURED WITH ACTIGRAPH wGT3X-BT
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)
Weight
measured in Kg.
Height
Measured in cm.

Full Information

First Posted
September 5, 2019
Last Updated
March 30, 2020
Sponsor
Universidad Católica San Antonio de Murcia
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1. Study Identification

Unique Protocol Identification Number
NCT04105192
Brief Title
Effectiveness of a Natural Ingredient on Obesity
Acronym
(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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
November 20, 2019 (Actual)
Study Completion Date
November 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Católica San Antonio de Murcia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity, High Blood Pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
experimental group (Lippia citriodora + sabdariffa)
Arm Type
Experimental
Arm Description
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.
Arm Title
control group Placebo (sucrose)
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
dietary supplement consumption
Intervention Description
Consumption of the product under study for 84 days, plecebo or experimental product
Primary Outcome Measure Information:
Title
Total fat mass
Description
Dual X-ray absorptiometry (DEXA), measured in grams.
Time Frame
From baseline to 84 days
Title
Fat mass in torso
Description
Dual X-ray absorptiometry (DEXA), measured in grams.
Time Frame
From baseline to 84 days
Title
Fat mass in lower limbs
Description
Dual X-ray absorptiometry (DEXA), measured in grams.
Time Frame
From baseline to 84 days
Secondary Outcome Measure Information:
Title
Fat mass
Description
Bioimpedancetry, in grams.
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.
Title
Muscle mass
Description
Bioimpedancetry, in grams.
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.
Title
Percentage of fat mass
Description
Bioimpedancetry.
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.
Title
blood samples: Glucidal metabolism and lipid metabolism.
Description
BASIC GLUCEMIA, TOTAL CHOLESTEROL, HDL CHOLESTEROL, LDL , CHOLESTEROL, TRIGLICERIDS, GLICATED HEMOGLOBIN. It was measured in milligrams per deciliter
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.
Title
Subjective sensation of product consumption
Description
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
Time Frame: Subjects will complete the hedonic scale four times. at 14, 28, 56 and 84 days of consumption of the product under study.
Title
physical activity
Description
MEASURED WITH ACTIGRAPH wGT3X-BT
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
Title
liver safety variables
Description
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)
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.
Title
Weight
Description
measured in Kg.
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).
Title
Height
Description
Measured in cm.
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Catholic University of Murcia
City
Murcia
ZIP/Postal Code
30107
Country
Spain

12. IPD Sharing Statement

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Effectiveness of a Natural Ingredient on Obesity

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