Effectiveness of a Natural Ingredient on Appetite Regulation (SAC)

Universidad Católica San Antonio de Murcia

Status: Completed

Conditions: Overweight and Obesity; Appetite Regulation

Treatments: Dietary Supplement: Dietary supplement consumption

Study type: Interventional

Funder types: Other

Identifiers

NCT04345029

UCAMCFE-00012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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36 participants in 2 patient groups, including a placebo group

Experimental group (Lippia citriodora + sabdariffa)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Dietary supplement consumption

control group Placebo (sucrose)

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Dietary supplement consumption