Efficacy of Satisens® in Reducing Emotional Eating (Satisens)

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.

Study Overview

• Status: Completed
• Conditions: Body Weight; Overweight or Obesity; Appetite Regulation; Emotional Eating; Neurotransmitter Agents; Food Cravings; Hormonal Changes; Inflammation Biomarkers
• Intervention / Treatment: Dietary supplement: Intervention 1: Satisens®; Dietary supplement: Intervention 2: Placebo

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 Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia
    • Valencia, Valencia, Spain, 46001
      • Universidad Católica de Valencia San Vicente Mártir - Facultad de Medicina y Ciencias de la Salud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: Intervention 1: Satisens®; A dietary supplement composed of lemon verbena (Lippia citriodora), hibiscus (Hibiscus sabdariffa), saffron (Crocus sativus), and carob extract. Administered as 2 capsules daily with breakfast or lunch. Used to modulate appetite, emotional eating, and inflammatory markers.; Other Names: Satisens®; Plant-based satiety supplement
Experimental: Arm 1.1: Satisens® 12 Weeks; Subgroup of Arm 1 continues with Satisens® for an additional 4 weeks (total 12 weeks). Same dosage and administration as initial 8 weeks.	Dietary supplement: Intervention 1: Satisens®; A dietary supplement composed of lemon verbena (Lippia citriodora), hibiscus (Hibiscus sabdariffa), saffron (Crocus sativus), and carob extract. Administered as 2 capsules daily with breakfast or lunch. Used to modulate appetite, emotional eating, and inflammatory markers.; Other Names: Satisens®; Plant-based satiety supplement
Experimental: Arm 1.2: Satisens® 8 Weeks + Placebo 4 Weeks; Subgroup of Arm 1 receives Satisens® for 8 weeks followed by placebo for 4 weeks. Placebo capsules are identical in appearance and administration.	Dietary supplement: Intervention 1: Satisens®; A dietary supplement composed of lemon verbena (Lippia citriodora), hibiscus (Hibiscus sabdariffa), saffron (Crocus sativus), and carob extract. Administered as 2 capsules daily with breakfast or lunch. Used to modulate appetite, emotional eating, and inflammatory markers.; Other Names: Satisens®; Plant-based satiety supplement; Dietary supplement: Intervention 2: Placebo; Identical in appearance to the active supplement. Contains water with sucrose and no active ingredients. Administered as 2 capsules daily with breakfast or lunch.; Other Names: Placebo capsule; Sucrose capsule
Placebo Comparator: Arm 2: Placebo 8 Weeks; Participants receive placebo capsules for 8 weeks. Capsules are identical in appearance to Satisens® and contain inert ingredients.	Dietary supplement: Intervention 2: Placebo; Identical in appearance to the active supplement. Contains water with sucrose and no active ingredients. Administered as 2 capsules daily with breakfast or lunch.; Other Names: Placebo capsule; Sucrose capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Emotional Eating Score (EEQ)	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).	Baseline, Week 8, Week 12
Change in Appetite Score (VAS)	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.	Baseline, Week 8, Week 12
Change in Sweet Craving (PFS)	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.	Baseline, Week 8, Week 12
Change in Body Weight	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.	Baseline, Week 8, Week 12
Change in Body Mass Index (BMI)	Calculated as weight (kg) divided by height squared (m²). Unit of Measure: kg/m² Interpretation: A decrease in BMI indicates a better outcome.	Baseline, Week 8, Week 12
Change in Waist Circumference	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.	Baseline, Week 8, Week 12
Change in Waist-to-Hip Ratio (WHR)	Calculated as waist circumference divided by hip circumference. Unit of Measure: Ratio (unitless) Interpretation: A decrease in WHR indicates a better outcome.	Baseline, Week 8, Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Appetite-Related Hormones	Blood levels of different Appetite-Related Hormones	Baseline, Week 8, Week 12
Change in Neurotransmitter Levels	Blood levels of different Neurotransmitter	Baseline, Week 8, Week 12
Change in Leptin Levels	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.	Baseline, Week 8, Week 12
Change in Adiponectin Levels	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).	Baseline, Week 8, Week 12
Change in Ghrelin Levels	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).	Baseline, Week 8, Week 12
Change in Interleukin-6 (IL-6) Levels	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).	Baseline, Week 8, Week 12
Change in Tumor Necrosis Factor-alpha (TNF-α) Levels	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).	Baseline, Week 8, Week 12

Collaborators and Investigators

• Sponsor: José Enrique de la Rubia Ortí, Ph
• Collaborators: VINABAS FORMULATIONS SL
• Investigators: Principal Investigator: José Enrique Dr. de la Rubia Ortí, PhD in Pharmacy, Universidad Católica de Valencia San Vicente Mártir; Principal Investigator: Gonzalo Mariscal Ruiz-Rico, Universidad Católica de Valencia San Vicente Mártir; Study Director: Ana Belén Carriquí Suárez, Facultad de Medicina y Ciencias de la Salud, Universidad Católica de Valencia

Publications and helpful links

Helpful Links

• Official website of Universidad Católica de Valencia San Vicente Mártir, where the study is being conducted.
• Official profile of Dr. José Enrique de la Rubia Ortí and his research group "El estrés y la enfermedad" at the Catholic University of Valencia. Includes academic background, research lines, and scientific publications.
• Official website of IVB Wellness Lab, the company collaborating on the clinical trial. Founded by Dr. Isabel Viña Bas, the company develops scientifically backed nutritional supplements, including SatiSens.
• Official news release from the Catholic University of Valencia announcing the clinical trial on a saffron-based supplement aimed at reducing sweet cravings and emotional eating.
• Media article discussing the potential of the saffron-based supplement SatiSens as a natural alternative to appetite suppressants, highlighting its role in the clinical trial.

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2025
• Primary Completion (Actual): December 18, 2025
• Study Completion (Actual): January 1, 2026

Study Registration Dates

• First Submitted: June 18, 2025
• First Submitted That Met QC Criteria: July 18, 2025
• First Posted (Actual): July 22, 2025

Study Record Updates

• Last Update Posted (Actual): June 22, 2026
• Last Update Submitted That Met QC Criteria: June 17, 2026
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Inflammation; Biomarkers; Clinical Trial; Polyphenols; Obesity Prevention; Dietary Supplement; Appetite Regulation; Food Craving; Plant Extracts; Hibiscus sabdariffa; Nutritional Intervention; Lemon Verbena; Emotional Eating; Sweet Cravings
• Additional Relevant MeSH Terms: Pathologic Processes; Nutrition Disorders; Overnutrition; Pathological Conditions, Signs and Symptoms; Behavior; Nutritional and Metabolic Diseases; Signs and Symptoms; Feeding Behavior; Overweight; Obesity; Body Weight; Inflammation; Emotional Eating; Carbohydrates; Polysaccharides; Disaccharides; Oligosaccharides; Sugars; Sucrose
• Other Study ID Numbers: UCV/2024-2025/015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared due to institutional data protection policies and the nature of the study, which involves sensitive health-related and psychological information. Data will be handled in compliance with the EU General Data Protection Regulation (GDPR) and Spanish data protection laws, and will remain confidential and accessible only to the research team.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No