Efficacy of Satisens® in Reducing Emotional Eating

Not Applicable

Not yet recruiting

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

• Registration Number: NCT07079046
• Lead Sponsor: José Enrique de la Rubia Ortí, Ph

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2025-06-18
• Status Verified: 2025-07
• Study Start: 2025-07-01
• Study First Submitted QC: 2025-07-18
• Last Update Submitted: 2025-07-18
• Study First Posted: 2025-07-22
• Last Update Posted: 2025-07-22
• Primary Completion: 2026-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Waist-to-Hip Ratio (WHR)	Baseline, Week 8, Week 12	Calculated as waist circumference divided by hip circumference. Unit of Measure: Ratio (unitless) Interpretation: A decrease in WHR indicates a better outcome.
Change in Emotional Eating Score (EEQ)	Baseline, Week 8, Week 12	Measured using the Emotional Eating Questionnaire (EEQ) to assess changes in emotional eating behavior.; Scale Range: 0 to 30 Interpretation: Higher scores indicate worse emotional eating behavior (i.e., greater tendency to eat in response to emotions).
Change in Waist Circumference	Baseline, Week 8, Week 12	Measured in centimeters (cm) at the midpoint between the lower margin of the last palpable rib and the top of the iliac crest.; Unit of Measure: Centimeters (cm) Interpretation: A decrease in waist circumference indicates a better outcome.
Change in Appetite Score (VAS)	Baseline, Week 8, Week 12	Visual Analog Scale adapted for appetite, including hunger, satiety, fullness, and prospective food consumption.; Scale Range: 0 to 100 for each item Interpretation: Higher scores indicate greater satiety and lower appetite. Therefore, a higher PA score reflects a better outcome in terms of appetite control.
Change in Body Weight	Baseline, Week 8, Week 12	Measured in kilograms (kg) using a calibrated scale with participants in a fasting state.; Unit of Measure: Kilograms (kg) Interpretation: A decrease in weight indicates a better outcome.
Change in Body Mass Index (BMI)	Baseline, Week 8, Week 12	Calculated as weight (kg) divided by height squared (m²). Unit of Measure: kg/m² Interpretation: A decrease in BMI indicates a better outcome.
Change in Sweet Craving (PFS)	Baseline, Week 8, Week 12	Power of Food Scale adapted to sweet foods to assess psychological craving. Scale Range: 1 to 5 per item (typically 15 items total; total score range: 15 to 75) Interpretation: Higher scores indicate greater psychological craving for sweet foods, thus a worse outcome in the context of this study.

Secondary Outcome Measures

Name	Time	Method
Change in Appetite-Related Hormones	Baseline, Week 8, Week 12	Blood levels of different Appetite-Related Hormones
Change in Neurotransmitter Levels	Baseline, Week 8, Week 12	Blood levels of different Neurotransmitter
Change in Leptin Levels	Baseline, Week 8, Week 12	Measured in serum using ELISA. Leptin is a hormone secreted by adipocytes that signals satiety to the hypothalamus.; Unit of Measure: ng/mL Interpretation: A decrease in leptin levels (in the context of leptin resistance) may indicate improved sensitivity and better appetite regulation.
Change in Adiponectin Levels	Baseline, Week 8, Week 12	Measured in serum using ELISA. Adiponectin is an anti-inflammatory adipokine associated with improved metabolic health and satiety.; Unit of Measure: µg/mL Interpretation: An increase in adiponectin levels indicates a better outcome (improved metabolic and inflammatory profile).
Change in Ghrelin Levels	Baseline, Week 8, Week 12	Measured in serum using ELISA. Ghrelin is known as the "hunger hormone" and stimulates appetite.; Unit of Measure: pg/mL Interpretation: A decrease in ghrelin levels indicates a better outcome (reduced hunger signaling).
Change in Interleukin-6 (IL-6) Levels	Baseline, Week 8, Week 12	Measured in serum using ELISA (Enzyme-Linked Immunosorbent Assay). Unit of Measure: pg/mL Interpretation: A decrease in IL-6 levels indicates a better outcome (reduced inflammation).
Change in Tumor Necrosis Factor-alpha (TNF-α) Levels	Baseline, Week 8, Week 12	Measured in serum using ELISA (Enzyme-Linked Immunosorbent Assay). Unit of Measure: pg/mL Interpretation: A decrease in TNF-α levels indicates a better outcome (reduced inflammation).

Trial Locations

Locations (1)

Universidad Católica de Valencia San Vicente Mártir - Facultad de Medicina y Ciencias de la Salud; 🇪🇸 Valencia, Valencian Community, Spain