Efficacy of Satisens® in Reducing Emotional Eating
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Change in Waist-to-Hip Ratio (WHR)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18 to 65 years
- •Healthy individuals without chronic diseases
- •Able to provide informed consent
排除标准
- •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
研究组 & 干预措施
Arm 1: Satisens® 8 Weeks
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.
干预措施: Intervention 1: Satisens® (Dietary Supplement)
Arm 1.1: Satisens® 12 Weeks
Subgroup of Arm 1 continues with Satisens® for an additional 4 weeks (total 12 weeks). Same dosage and administration as initial 8 weeks.
干预措施: Intervention 1: Satisens® (Dietary Supplement)
Arm 1.2: Satisens® 8 Weeks + Placebo 4 Weeks
Subgroup of Arm 1 receives Satisens® for 8 weeks followed by placebo for 4 weeks. Placebo capsules are identical in appearance and administration.
干预措施: Intervention 1: Satisens® (Dietary Supplement)
Arm 1.2: Satisens® 8 Weeks + Placebo 4 Weeks
Subgroup of Arm 1 receives Satisens® for 8 weeks followed by placebo for 4 weeks. Placebo capsules are identical in appearance and administration.
干预措施: Intervention 2: Placebo (Dietary Supplement)
Arm 2: Placebo 8 Weeks
Participants receive placebo capsules for 8 weeks. Capsules are identical in appearance to Satisens® and contain inert ingredients.
干预措施: Intervention 2: Placebo (Dietary Supplement)
结局指标
主要结局
Change in Waist-to-Hip Ratio (WHR)
时间窗: 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.
Change in Emotional Eating Score (EEQ)
时间窗: 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 Waist Circumference
时间窗: 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 Appetite Score (VAS)
时间窗: 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 Body Weight
时间窗: 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)
时间窗: 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 Sweet Craving (PFS)
时间窗: 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.
次要结局
- 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)
- Change in Interleukin-6 (IL-6) Levels(Baseline, Week 8, Week 12)
- Change in Tumor Necrosis Factor-alpha (TNF-α) Levels(Baseline, Week 8, Week 12)
研究者
José Enrique de la Rubia Ortí, Ph
Principal Investigator
Fundación Universidad Católica de Valencia San Vicente Mártir