Effectiveness of a Natural Ingredient on Obesity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2019-11-25

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Overweight and Obesity High Blood Pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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experimental group (Lippia citriodora + sabdariffa)

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.

Group Type EXPERIMENTAL

dietary supplement consumption

Intervention Type DIETARY_SUPPLEMENT

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

control group Placebo (sucrose)

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.

Group Type PLACEBO_COMPARATOR

dietary supplement consumption

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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dietary supplement consumption

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes