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Completed

NCT Number: NCT07079046

Efficacy of Satisens® in Reducing Emotional Eating

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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Key information

Conditions

Emotional Eating Appetite Regulation Behavior Body Weight Feeding Behavior Food Cravings Hormonal Changes Inflammation Inflammation Biomarkers Neurotransmitter Agents Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight or Obesity Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Valencia, 46001, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Satisens®, Plant-based satiety supplement

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.

Other names: Placebo capsule, Sucrose capsule

Primary outcomes

  1. Change in Emotional Eating Score (EEQ)

    Time frame: 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).

  2. Change in Appetite Score (VAS)

    Time frame: 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.

  3. Change in Sweet Craving (PFS)

    Time frame: 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.

  4. Change in Body Weight

    Time frame: 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.

  5. Change in Body Mass Index (BMI)

    Time frame: 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.

  6. Change in Waist Circumference

    Time frame: 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.

  7. Change in Waist-to-Hip Ratio (WHR)

    Time frame: 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.

Secondary outcomes

  1. Change in Appetite-Related Hormones

    Time frame: Baseline, Week 8, Week 12

    Blood levels of different Appetite-Related Hormones

  2. Change in Neurotransmitter Levels

    Time frame: Baseline, Week 8, Week 12

    Blood levels of different Neurotransmitter

  3. Change in Leptin Levels

    Time frame: 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.

  4. Change in Adiponectin Levels

    Time frame: 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).

  5. Change in Ghrelin Levels

    Time frame: 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).

  6. Change in Interleukin-6 (IL-6) Levels

    Time frame: 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).

  7. Change in Tumor Necrosis Factor-alpha (TNF-α) Levels

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

José Enrique de la Rubia Ortí, Ph

Other

Collaborators

  • VINABAS FORMULATIONS SL

Registry information

Acronym: Satisens

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jul 22, 2025
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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