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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
84
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.
Identical in appearance to the active supplement. Contains water with sucrose and no active ingredients. Administered as 2 capsules daily with breakfast or lunch.
Universidad Católica de Valencia San Vicente Mártir - Facultad de Medicina y Ciencias de la Salud
Valencia, Valencia, Spain
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Week 8, Week 12
Change in Appetite-Related Hormones
Blood levels of different Appetite-Related Hormones
Time frame: Baseline, Week 8, Week 12
Change in Neurotransmitter Levels
Blood levels of different Neurotransmitter
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
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Time frame: Baseline, Week 8, Week 12