Efficacy of Satisens® in Reducing Emotional Eating

NCT07079046 | Not Yet Recruiting

• 1 other identifier: UCV/2024-2025/015
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Emotional Eating; Appetite Regulation; Food Craving; Sweet Cravings; Obesity Prevention; Dietary Supplement; Plant Extracts; Lemon Verbena; Hibiscus sabdariffa; Polyphenols; Inflammation; Nutritional Intervention; Clinical Trial; Biomarkers

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (7)

• Change in Appetite-Related Hormones

  Baseline, Week 8, Week 12

• Change in Neurotransmitter Levels

  Baseline, Week 8, Week 12

• Change in Leptin Levels

  Baseline, Week 8, Week 12

• Change in Adiponectin Levels

  Baseline, Week 8, Week 12

• Change in Ghrelin Levels

  Baseline, Week 8, Week 12

Study Arms (4)

Arm 1: Satisens® 8 Weeks

EXPERIMENTAL

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®

Arm 1.1: Satisens® 12 Weeks

EXPERIMENTAL

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®

Arm 1.2: Satisens® 8 Weeks + Placebo 4 Weeks

EXPERIMENTAL

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®; Dietary Supplement: Intervention 2: Placebo

Arm 2: Placebo 8 Weeks

PLACEBO COMPARATOR

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

Dietary Supplement: Intervention 2: Placebo

Interventions

Intervention 1: Satisens® DIETARY_SUPPLEMENT

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.

Also known as: Satisens®, Plant-based satiety supplement

Arm 1.1: Satisens® 12 Weeks; Arm 1.2: Satisens® 8 Weeks + Placebo 4 Weeks; Arm 1: Satisens® 8 Weeks

Intervention 2: Placebo DIETARY_SUPPLEMENT

Identical in appearance to the active supplement. Contains water with sucrose and no active ingredients. Administered as 2 capsules daily with breakfast or lunch.

Also known as: Placebo capsule, Sucrose capsule

Arm 1.2: Satisens® 8 Weeks + Placebo 4 Weeks; Arm 2: Placebo 8 Weeks

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• José Enrique de la Rubia Ortí, Ph: lead
• VINABAS FORMULATIONS SL: collaborator

Study Sites (1)

Universidad Católica de Valencia San Vicente Mártir - Facultad de Medicina y Ciencias de la Salud

Valencia, Valencia, 46001, Spain

Location

Related 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.

MeSH Terms

Conditions

Emotional Eating; Overweight; Obesity; Body Weight; Inflammation

Interventions

Sucrose

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Ana Belén Carriquí Suárez

  Facultad de Medicina y Ciencias de la Salud, Universidad Católica de Valencia

  STUDY DIRECTOR

Central Study Contacts

José Enrique Dr. de la Rubia Ortí, PhD in Pharmacy

CONTACT

+34 963 637 412; joseenrique.delarubi@ucv.es

María Dr. Benlloch García, PhD in Biology

CONTACT

+34 963 637 412; maria.benlloch@ucv.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: July 22, 2025
• Study Start: July 1, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)