Effectiveness of a Natural Ingredient on Obesity

Not Applicable

Completed

• Conditions: High Blood Pressure; Overweight and Obesity
• Interventions: Dietary Supplement: dietary supplement consumption

• Registration Number: NCT04105192
• Lead Sponsor: Universidad Católica San Antonio de Murcia

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.

Study Timeline

• Study Start: 2019-03-01
• Study First Submitted: 2019-09-05
• Study First Submitted QC: 2019-09-24
• Study First Posted: 2019-09-26
• Primary Completion: 2019-11-20
• Study Completion: 2019-11-25
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-30
• Last Update Posted: 2020-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group Placebo (sucrose)	dietary supplement consumption	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.
experimental group (Lippia citriodora + sabdariffa)	dietary supplement consumption	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.	Bioimpedancetry.
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.	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.
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.	BASIC GLUCEMIA, TOTAL CHOLESTEROL, HDL CHOLESTEROL, LDL , CHOLESTEROL, TRIGLICERIDS, GLICATED HEMOGLOBIN. It was measured in milligrams per deciliter
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.	Bioimpedancetry, in grams.
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	MEASURED WITH ACTIGRAPH wGT3X-BT
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.	Bioimpedancetry, in grams.
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).	Measured in cm.
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.	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	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.

Trial Locations

Locations (1)

Catholic University of Murcia; 🇪🇸 Murcia, Spain