Efficacy of Satisens® in Reducing Emotional Eating

José Enrique de la Rubia Ortí, Ph

Status: Not yet enrolling

Conditions: Inflammation Biomarkers; Overweight or Obesity; Neurotransmitter Agents; Food Cravings; Emotional Eating; Body Weight; Appetite Regulation; Hormonal Changes

Treatments: Dietary Supplement: Intervention 2: Placebo; Dietary Supplement: Intervention 1: Satisens®

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07079046

UCV/2024-2025/015

Details and patient eligibility

About

This study evaluates the efficacy of Satisens®, a dietary supplement composed of plant extracts, in reducing emotional eating and sweet cravings in healthy adults. The study will analyze hormonal, neurotransmitter, and inflammatory markers to understand the underlying mechanisms.

Full description

This study aims to evaluate the efficacy of Satisens®, a dietary supplement composed of lemon verbena (Lippia citriodora), hibiscus (Hibiscus sabdariffa), and saffron (Crocus sativus), in reducing emotional eating and sweet cravings in healthy adults. The supplement is hypothesized to modulate appetite through neuroendocrine and anti-inflammatory mechanisms.

The study is a prospective, longitudinal, mixed-method, analytical, and experimental clinical trial. Participants will be randomly assigned to intervention or placebo groups. The intervention group will receive two capsules of Satisens® daily for 8 weeks, with a subgroup continuing for an additional 4 weeks or switching to placebo. The placebo group will receive identical capsules without active ingredients.

Primary outcomes include changes in emotional eating, appetite, sweet cravings, body weight, BMI, waist circumference, and waist-to-hip ratio. Secondary outcomes include blood levels of appetite-related hormones, neurotransmitters, and inflammatory markers.

Emotional eating will be assessed using validated questionnaires (EEQ, VAS, PFS). Blood samples will be analyzed using chromatography and mass spectrometry techniques. Statistical analysis will include paired t-tests or Wilcoxon tests, Mann-Whitney U tests, correlation analysis, and structural equation modeling.

The study has received ethical approval from the Ethics Committee of the Universidad Católica de Valencia San Vicente Mártir (code: UCV/2024-2025/015) and complies with the Declaration of Helsinki and GDPR regulations.

Enrollment: 84 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults aged 18 to 65 years
• Healthy individuals without chronic diseases
• Able to provide informed consent

Exclusion criteria

• Pregnant or breastfeeding women
• Individuals taking medications or supplements that may interfere with study variables
• Individuals engaging in more than 3 hours of active exercise per week

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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84 participants in 4 patient groups, including a placebo group

Arm 1: Satisens® 8 Weeks

Experimental group

Description:

Participants receive 2 capsules of Satisens® daily for 8 weeks. The supplement contains lemon verbena, hibiscus, saffron, and other plant extracts. Capsules are taken with breakfast or lunch.

Treatment:

Dietary Supplement: Intervention 1: Satisens®

Arm 1.1: Satisens® 12 Weeks

Experimental group

Description:

Subgroup of Arm 1 continues with Satisens® for an additional 4 weeks (total 12 weeks). Same dosage and administration as initial 8 weeks.

Treatment:

Dietary Supplement: Intervention 1: Satisens®

Arm 1.2: Satisens® 8 Weeks + Placebo 4 Weeks

Experimental group

Description:

Subgroup of Arm 1 receives Satisens® for 8 weeks followed by placebo for 4 weeks. Placebo capsules are identical in appearance and administration.

Treatment:

Dietary Supplement: Intervention 1: Satisens®

Dietary Supplement: Intervention 2: Placebo

Arm 2: Placebo 8 Weeks

Placebo Comparator group

Description:

Participants receive placebo capsules for 8 weeks. Capsules are identical in appearance to Satisens® and contain inert ingredients.

Treatment:

Dietary Supplement: Intervention 2: Placebo