Advanced Strategy of Food Supplements for the Optimization of Satiety and Lipid Metabolism in Maturity (SACIANS) (SACIANS)

Advanced Strategy of Food Supplements for the Optimization of Satiety and Lipid Metabolism in Maturity

The SACIANS study (Advanced Strategy of Food Supplements for the Optimization of Satiety and Lipid Metabolism in Middle-Aged Adults) aims to evaluate the combined effect of commercially available food supplements on satiety and lipid metabolism in adults over 45 years of age who are overweight.

This 12-week randomized controlled clinical trial will include 80 participants divided into two parallel groups: a control group without supplementation and an experimental group receiving a specific combination of food supplements with proven nutritional safety and previous evidence of functional effects on metabolism.

Primary outcomes include changes in biochemical parameters related to lipid metabolism (cholesterol profile, triglycerides, and glucose), as well as markers of oxidative stress and inflammation. Secondary outcomes include variations in body composition, perceived satiety, emotional well-being, sleep quality, and lifestyle habits such as diet adherence and physical activity.

The study will be conducted at the University of Alicante and the EIEH Clinic (Elche Institute of Exercise and Health), following the principles of the Declaration of Helsinki. The goal is to provide scientific evidence on the synergistic potential of existing food supplement combinations to promote metabolic balance and healthy aging.

Study Overview

• Status: Completed
• Conditions: Dyslipidemia; Overweight and/or Obesity; Lipid Metabolism; Satiety Response
• Intervention / Treatment: Dietary supplement: Food Supplement Combination (SACIANS Formula)

Detailed Description

Overweight and metabolic alterations in adults over 45 years old represent a growing public health concern, frequently associated with conditions such as type 2 diabetes, dyslipidemia, and cardiovascular disease. Although numerous food supplements are currently available on the market with reported effects on satiety or lipid oxidation, most lack personalization and evidence regarding their combined effects.

The SACIANS project (Advanced Strategy of Food Supplements for the Optimization of Satiety and Lipid Metabolism in Middle-Aged Adults) is a 12-week, randomized, controlled, parallel-group clinical trial designed to evaluate the efficacy of different combinations of commercially available food supplements on metabolic and emotional parameters in adults with overweight or mild obesity.

Participants (n = 80; 40 per group) will be randomly assigned to one of two arms:

Control group: No supplementation.

Experimental group: Daily intake of a combination of registered food supplements selected based on their nutritional profile, labeling, safety, and prior evidence of functional efficacy.

Assessments will include biochemical parameters (glucose, lipid profile, oxidative and inflammatory biomarkers), body composition (via bioimpedance and 3D scanning), blood pressure, and psychological well-being (stress, anxiety, and sleep quality). Lifestyle factors such as Mediterranean diet adherence and physical activity (recorded with Fitbit) will also be monitored.

The trial will follow the ethical standards of the Declaration of Helsinki and has been approved by the Ethics Committee of the University of Alicante (approval date: May 29, 2025). Statistical analyses will be performed using SPSS v24.0, applying repeated-measures ANOVA and appropriate post hoc corrections.

This study aims to identify potential synergistic effects among existing food supplement formulations, contributing to the rational and evidence-based use of these products for improving satiety, lipid metabolism, and metabolic health in adults.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Alicante
    • Elche, Alicante, Spain, 03203
      • European Institute Of Exercise and Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age ≥ 45 years
• Body Mass Index (BMI) between 25.0 and 34.9 kg/m²
• Signed informed consent form

Exclusion Criteria:

• Pregnancy or breastfeeding
• Participation in similar studies within the previous 3 months
• Current use of supplements or medications that may affect metabolism
• Joint injury or physical limitation that restricts participation
• Clinical conditions that could prevent adherence to the study protocol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group - Food Supplement Combination; Participants in this group will receive a daily combination of commercially available food supplements for 12 weeks. The selection of supplements will be based on safety criteria, nutritional labeling, and prior evidence of beneficial effects on satiety and lipid metabolism. The supplements are registered as food supplements available in pharmacies and herbal stores. Participants will maintain their habitual diet and lifestyle throughout the study period.	Dietary supplement: Food Supplement Combination (SACIANS Formula); Participants in the experimental group will receive a combination of commercially available food supplements daily for 12 weeks. The specific supplements will be selected based on safety, labeling accuracy, and prior evidence of beneficial effects on satiety and lipid metabolism. All supplements are registered as food supplements and are commercially available in pharmacies and herbal stores. The combination aims to enhance satiety, improve lipid metabolism, and promote metabolic health in overweight adults. Participants will be instructed to maintain their usual diet and lifestyle habits throughout the intervention period.
No Intervention: Control Group - No Supplementation; Participants in this group will not receive any supplementation during the 12-week study period. They will maintain their usual diet and lifestyle, serving as the control group for comparison with the experimental supplementation group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in total cholesterol	Variation in plasma total cholesterol concentration after 12 weeks of supplementation.	Baseline and after 12 weeks of intervention
Change in LDL-cholesterol	Variation in low-density lipoprotein (LDL) cholesterol levels to evaluate lipid metabolism response.	Baseline and after 12 weeks of intervention
Change in perceived satiety levels	Evaluation of subjective satiety using a validated visual analog scale (VAS) for appetite and fullness.	Baseline and after 12 weeks of intervention
Change in HDL-cholesterol	Variation in high-density lipoprotein (HDL) cholesterol levels as an indicator of cardiovascular health.	Baseline and after 12 weeks of intervention
Change in triglycerides	Variation in plasma triglyceride concentration	Baseline and after 12 weeks of intervention
Change in fasting glucose	Difference in fasting blood glucose concentration after the intervention period.	Baseline and after 12 weeks of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body weight	Change in total body weight measured using a calibrated scale.	Baseline and after 12 weeks of intervention
Change in body fat percentage	Variation in body fat percentage measured by 3D body scan (SCANECA).	Baseline and after 12 weeks of intervention
Change in lean mass	Difference in lean body mass determined by bioimpedance and 3D body scan (SCANECA).	Baseline and after 12 weeks of intervention
Change in C-reactive protein (CRP)	Variation in serum CRP concentration as a marker of systemic inflammation	Baseline and after 12 weeks of intervention
Change in malondialdehyde (MDA)	Difference in plasma MDA concentration as an oxidative stress biomarker	Baseline and week 12
Change in total antioxidant capacity (TAC)	Variation in total antioxidant capacity of plasma	Baseline and week 12
Change in perceived stress (PSS questionnaire)	Range: 0-40. Interpretation: Higher scores indicate greater perceived stress. Description: The PSS-10 is a 10-item self-reported questionnaire that measures the degree to which situations in one's life are appraised as stressful during the past month. Items are rated on a 5-point Likert scale (0 = never to 4 = very often). Scores are summed to obtain a total perceived stress score, where higher values reflect greater stress perception.	Baseline and week 12
Change in sleep quality (PSQI)	Range: 0-21. Interpretation: Higher scores indicate worse sleep quality. Description: The PSQI is a self-reported questionnaire that assesses sleep quality and disturbances over a 1-month period. It consists of 19 items grouped into seven components (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction), each scored 0-3. The sum of the components yields a global score (0-21).	Baseline and week 12
Change in Mediterranean diet adherence (PREDIMED score)	Range: 0-14. Interpretation: Higher scores indicate better adherence to the Mediterranean diet. Description: The PREDIMED questionnaire evaluates adherence to the Mediterranean dietary pattern through 14 items covering key aspects such as olive oil intake, fruit and vegetable consumption, fish intake, and limited consumption of red meat and sweets. Each affirmative answer scores 1 point.	Baseline and week 12
Change in physical activity level (IPAQ questionnaire)	Range: 0 to unlimited MET-min/week (commonly categorized into 3 levels: low, moderate, high). Interpretation: Higher scores indicate higher levels of physical activity. Description: The IPAQ-SF measures physical activity over the last 7 days through 7 items that estimate the time spent walking, and performing moderate and vigorous activities. Results are expressed in MET-minutes per week or categorized according to intensity.	Baseline and week 12

Collaborators and Investigators

• Sponsor: University of Alicante

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Actual): August 30, 2025
• Study Completion (Actual): August 30, 2025

Study Registration Dates

• First Submitted: November 25, 2025
• First Submitted That Met QC Criteria: November 25, 2025
• First Posted (Estimated): December 8, 2025

Study Record Updates

• Last Update Posted (Actual): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Overweight; Body composition; Satiety; Metabolic health; Mediterranean diet; Lipid metabolism; Nutraceuticals; Food supplements; Middle-aged adults
• Additional Relevant MeSH Terms: Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Lipid Metabolism Disorders; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Dyslipidemias
• Other Study ID Numbers: UA-2025-04-15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No