Effectiveness of a Natural Ingredient on Appetite Regulation

NCT ID: NCT04345029

Last Updated: 2020-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-15
• Study Completion Date: 2020-06-30

Brief Summary

Single-center, double-blind, double-crossed, randomized controlled clinical trial with two crossed branches, designed with the objective of evaluating the effect of the investigational product on satiety.

Detailed Description

Subjects who meet the selection criteria will make a total of five visits to the research laboratory and will carry out the tests established in the protocol. Subsequently, a statistical analysis will be performed with the variables measured in the study to obtain results.

Conditions

Appetite Regulation; Overweight and Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental group (Lippia citriodora + sabdariffa)

Consumption for 60 days of Lippia citriodora 325 mg + Hibiscus sabdariffa 175 mg.

Two capsules per day will be consumed thirty minutes before breakfast orally for 60 days.

Group Type: EXPERIMENTAL

Dietary supplement consumption

Intervention Type: DIETARY_SUPPLEMENT

The experimental product consumption time was 60 days and the control consumption time was 60 days.

Each subject must consume both products, with a washing period of 30 days.

control group Placebo (sucrose)

Two capsules per day will be consumed thirty minutes before breakfast orally for 60 days.

Group Type: PLACEBO_COMPARATOR

Dietary supplement consumption

Intervention Type: DIETARY_SUPPLEMENT

The experimental product consumption time was 60 days and the control consumption time was 60 days.

Each subject must consume both products, with a washing period of 30 days.

Interventions

Dietary supplement consumption

The experimental product consumption time was 60 days and the control consumption time was 60 days.

Each subject must consume both products, with a washing period of 30 days.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Age 18-65 years.
• Both genders.
• BMI 25-34.9 kg / m2, both inclusive.
• Weight maintained during the last 3 months.
• Smoking subjects or not, but in any case they do not change their nicotinic habits during their participation in the study.
• Absence of disease diagnosed at the start of the study.

Exclusion Criteria

• Thyroid dysfunction, infections, or with any type of chronic disease (eg, autoimmune, inflammatory).
• History of allergic hypersensitivity or poor tolerance to any component of the products under study.
• Subjects who are performing or intend to carry out any type of diet, low-calorie or not, during the study.
• Participation in another clinical trial in the three months prior to the study.
• Lack of will or inability to comply with clinical trial procedures.
• Pregnant woman.
• Subjects whose condition does not make them eligible for the study according to the researcher's criteria.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad Católica San Antonio de Murcia

OTHER

Sponsor Role: lead

Responsible Party

Francisco Javier López Román

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Catholic University of Murcia

Murcia, , Spain

Countries

Spain

Other Identifiers

UCAMCFE-00012

Identifier Type: -

Identifier Source: org_study_id