Advanced Strategy of Food Supplements for the Optimization of Satiety and Lipid Metabolism in Maturity (SACIANS)
NCT ID: NCT07269795
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2024-09-01
2025-08-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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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.
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.
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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Body Mass Index (BMI) between 25.0 and 34.9 kg/m²
* Signed informed consent form
Exclusion Criteria
* 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
45 Years
ALL
Yes
Sponsors
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University of Alicante
OTHER
Responsible Party
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Prof. Dr. Alejandro Martínez-Rodríguez
Catedrático Ciencias de la Salud
Locations
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European Institute Of Exercise and Health
Elche, Alicante, Spain
Countries
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Other Identifiers
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UA-2025-04-15
Identifier Type: -
Identifier Source: org_study_id