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

University of Alicante

Status: Completed

Conditions: Lipid Metabolism; Overweight and/or Obesity; Satiety Response; Dyslipidemia

Treatments: Dietary Supplement: Food Supplement Combination (SACIANS Formula)

Study type: Interventional

Funder types: Other

Identifiers

NCT07269795

UA-2025-04-15

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 45+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Experimental Group - Food Supplement Combination

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Food Supplement Combination (SACIANS Formula)

Control Group - No Supplementation

No Intervention group

Description:

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.