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

Universidad Católica San Antonio de Murcia

Status: Completed

Conditions: High Blood Pressure; Overweight and Obesity

Treatments: Dietary Supplement: dietary supplement consumption

Study type: Interventional

Funder types: Other

Identifiers

NCT04105192

UCAMCFE-0010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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84 participants in 2 patient groups, including a placebo group

experimental group (Lippia citriodora + sabdariffa)

Experimental group

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.

Treatment:

Dietary Supplement: dietary supplement consumption

control group Placebo (sucrose)

Placebo Comparator group

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.

Treatment:

Dietary Supplement: dietary supplement consumption