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Emotional EatingSatisensNCT07079046

Efficacy of Satisens® in Reducing Emotional Eating

A study testing Intervention 1: Satisens® in people with Emotional Eating and Overweight or Obesity, run by José Enrique de la Rubia Ortí, Ph at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
Intervention 1: Satisens®
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
84 participants
Where
1 siteSpain
Study dates
15 Sep 2025to 1 Jan 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Universidad Católica de Valencia San Vicente Mártir - Facultad de Medicina y Ciencias de la Salud

    Valencia, Valencia, 46001

Other trials in Spain

About this study

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.

Read the 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.

Being tested
Intervention 1: Satisens®, Intervention 2: Placebo
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
Medical subject headings
Emotional Eating, Overweight, Obesity, Body Weight, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intervention 1: Satisens®Dietary supplement

    Also called Satisens®, Plant-based satiety 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.

  • Intervention 2: PlaceboDietary supplement

    Also called Placebo capsule, Sucrose capsule

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

Study groups in NCT07079046
Study groupRoleWhat they receive
Arm 1: Satisens® 8 WeeksExperimentalParticipants 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.
Receives: Dietary Supplement: Intervention 1: Satisens®
Arm 1.1: Satisens® 12 WeeksExperimentalSubgroup of Arm 1 continues with Satisens® for an additional 4 weeks (total 12 weeks). Same dosage and administration as initial 8 weeks.
Receives: Dietary Supplement: Intervention 1: Satisens®
Arm 1.2: Satisens® 8 Weeks + Placebo 4 WeeksExperimentalSubgroup of Arm 1 receives Satisens® for 8 weeks followed by placebo for 4 weeks. Placebo capsules are identical in appearance and administration.
Receives: Dietary Supplement: Intervention 1: Satisens®; Dietary Supplement: Intervention 2: Placebo
Arm 2: Placebo 8 WeeksPlacebo comparatorParticipants receive placebo capsules for 8 weeks. Capsules are identical in appearance to Satisens® and contain inert ingredients.
Receives: Dietary Supplement: Intervention 2: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Baseline, Week 8, Week 12

  2. 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.

    Measured: Baseline, Week 8, Week 12

  3. 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.

    Measured: Baseline, Week 8, Week 12

  4. 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.

    Measured: Baseline, Week 8, Week 12

  5. 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.

    Measured: Baseline, Week 8, Week 12

  6. 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.

    Measured: Baseline, Week 8, Week 12

  7. 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.

    Measured: Baseline, Week 8, Week 12

Secondary outcomes (7)
  1. Change in Appetite-Related Hormones

    Blood levels of different Appetite-Related Hormones

    Measured: Baseline, Week 8, Week 12

  2. Change in Neurotransmitter Levels

    Blood levels of different Neurotransmitter

    Measured: Baseline, Week 8, Week 12

  3. 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.

    Measured: Baseline, Week 8, Week 12

  4. 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).

    Measured: Baseline, Week 8, Week 12

  5. 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).

    Measured: Baseline, Week 8, Week 12

  6. 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).

    Measured: Baseline, Week 8, Week 12

  7. 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).

    Measured: Baseline, Week 8, Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2025
  2. Study start15 Sep 2025
  3. Primary completion18 Dec 2025
  4. Study completion1 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07079046
Sponsor's protocol ID
UCV/2024-2025/015
Acronym
Satisens
Status last verified
Jul 2025
First submitted
18 Jun 2025
Last updated
22 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Intervention 1: Satisens® in people with Emotional Eating and Overweight or Obesity, run by José Enrique de la Rubia Ortí, Ph at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Emotional Eating Score (EEQ) (time frame: Baseline, Week 8, Week 12). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.

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