Efficacy of Satisens® in Reducing Emotional Eating

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-31

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a prospective, longitudinal, mixed-method, analytical, and experimental clinical trial. Participants will be randomly assigned to one of three groups: an intervention group receiving Satisens® for 8 weeks, a placebo group, and a subgroup of the intervention group that will either continue with Satisens® or switch to placebo for an additional 4 weeks. The study uses a parallel assignment model to compare the effects of the intervention on emotional eating, appetite, and related biomarkers.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

This is a double-blind study. Neither the participants nor the investigators will know whether the subject is receiving Satisens® or placebo. The placebo capsules are identical in appearance and administration schedule to the active product.

Study Groups

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Arm 1: Satisens® 8 Weeks

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.

Group Type EXPERIMENTAL