Appetite Regulation, Body Weight, Emotional Eating, Food Cravings, Hormonal Changes, Inflammation Biomarkers, Neurotransmitter Agents, Overweight or Obesity
Conditions
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
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.
Interventions
DIETARY_SUPPLEMENTIntervention 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.
DIETARY_SUPPLEMENTIntervention 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.
Sponsors
José Enrique de la Rubia Ortí, Ph
VINABAS FORMULATIONS SL
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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. |
| 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 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 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Spain
Contacts
PRINCIPAL_INVESTIGATORJosé Enrique Dr. de la Rubia Ortí, PhD in Pharmacy
Universidad Católica de Valencia San Vicente Mártir
PRINCIPAL_INVESTIGATORGonzalo Mariscal Ruiz-Rico
Universidad Católica de Valencia San Vicente Mártir
STUDY_DIRECTORAna Belén Carriquí Suárez
Facultad de Medicina y Ciencias de la Salud, Universidad Católica de Valencia
Outcome results
None listed