DyslipidemiaSACIANSNCT07269795
Advanced Strategy of Food Supplements for the Optimization of Satiety and Lipid Metabolism in Maturity (SACIANS)
A study testing Food Supplement Combination (SACIANS Formula) in people with Dyslipidemia and Lipid Metabolism, run by University of Alicante at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemia, Lipid Metabolism, Satiety Response
- What is being tested?
- Food Supplement Combination (SACIANS Formula)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2024to 30 Aug 2025
- 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 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 45 years
- Body Mass Index (BMI) between 25.0 and 34.9 kg/m²
- Signed informed consent form
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- Food Supplement Combination (SACIANS Formula)
- Keywords
- Food supplements, Satiety, Lipid metabolism, Overweight, Middle-aged adults, Metabolic health, Nutraceuticals, Mediterranean diet, Body composition
- Medical subject headings
- Dyslipidemias, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food Supplement Combination (SACIANS Formula)Dietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group - Food Supplement Combination | Experimental | 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. Receives: Dietary Supplement: Food Supplement Combination (SACIANS Formula) |
| Control Group - No Supplementation | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Change in total cholesterol
Variation in plasma total cholesterol concentration after 12 weeks of supplementation.
Measured: Baseline and after 12 weeks of intervention
Change in LDL-cholesterol
Variation in low-density lipoprotein (LDL) cholesterol levels to evaluate lipid metabolism response.
Measured: 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.
Measured: 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.
Measured: Baseline and after 12 weeks of intervention
Change in triglycerides
Variation in plasma triglyceride concentration
Measured: Baseline and after 12 weeks of intervention
Change in fasting glucose
Difference in fasting blood glucose concentration after the intervention period.
Measured: Baseline and after 12 weeks of intervention
Secondary outcomes (10)
Change in body weight
Change in total body weight measured using a calibrated scale.
Measured: Baseline and after 12 weeks of intervention
Change in body fat percentage
Variation in body fat percentage measured by 3D body scan (SCANECA).
Measured: Baseline and after 12 weeks of intervention
Change in lean mass
Difference in lean body mass determined by bioimpedance and 3D body scan (SCANECA).
Measured: Baseline and after 12 weeks of intervention
Change in C-reactive protein (CRP)
Variation in serum CRP concentration as a marker of systemic inflammation
Measured: Baseline and after 12 weeks of intervention
Change in malondialdehyde (MDA)
Difference in plasma MDA concentration as an oxidative stress biomarker
Measured: Baseline and week 12
Change in total antioxidant capacity (TAC)
Variation in total antioxidant capacity of plasma
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Baseline and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start1 Sep 2024
- Primary completion30 Aug 2025
- Study completion30 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two parallel groups: a control group (no supplementation) and an intervention group (receiving the supplement combination). Both groups will follow their habitual diet and lifestyle during the 12-week intervention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alicante
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Alejandro Martínez-Rodríguez, University of Alicante
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07269795
- Sponsor's protocol ID
- UA-2025-04-15
- Acronym
- SACIANS
- Status last verified
- Dec 2025
- First submitted
- 25 Nov 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Strategy of Food Supplements for the Optimization of Satiety and Lipid Metabolism in Maturity
- ClinicalTrials.gov ID
- NCT07269795
- Acronym / sponsor ID
- SACIANS / UA-2025-04-15
- Keywords
- Food supplements, Satiety, Lipid metabolism, Overweight, Middle-aged adults, Metabolic health, Nutraceuticals, Mediterranean diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of AlicanteUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 8 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel groups: a control group (no supplementation) and an intervention group (receiving the supplement combination). Both groups will follow their habitual diet and lifestyle during the 12-week intervention.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group - Food Supplement Combination | Experimental | Dietary Supplement: Food Supplement Combination (SACIANS Formula)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. |
| Control Group - No Supplementation | No intervention | –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. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 45 years
- Body Mass Index (BMI) between 25.0 and 34.9 kg/m²
- Signed informed consent form
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | Experimental Group - Food Supplement Combination |
Primary outcome
Change in total cholesterol
Time frame: Baseline and after 12 weeks of intervention
Variation in plasma total cholesterol concentration after 12 weeks of supplementation.
Change in LDL-cholesterol
Time frame: Baseline and after 12 weeks of intervention
Variation in low-density lipoprotein (LDL) cholesterol levels to evaluate lipid metabolism response.
Change in perceived satiety levels
Time frame: Baseline and after 12 weeks of intervention
Evaluation of subjective satiety using a validated visual analog scale (VAS) for appetite and fullness.
Change in HDL-cholesterol
Time frame: Baseline and after 12 weeks of intervention
Variation in high-density lipoprotein (HDL) cholesterol levels as an indicator of cardiovascular health.
Change in triglycerides
Time frame: Baseline and after 12 weeks of intervention
Variation in plasma triglyceride concentration
Change in fasting glucose
Time frame: Baseline and after 12 weeks of intervention
Difference in fasting blood glucose concentration after the intervention period.
10 secondary outcomes
Change in body weight
Time frame: Baseline and after 12 weeks of intervention
Change in body fat percentage
Time frame: Baseline and after 12 weeks of intervention
Change in lean mass
Time frame: Baseline and after 12 weeks of intervention
Change in C-reactive protein (CRP)
Time frame: Baseline and after 12 weeks of intervention
Change in malondialdehyde (MDA)
Time frame: Baseline and week 12
Change in total antioxidant capacity (TAC)
Time frame: Baseline and week 12
Change in perceived stress (PSS questionnaire)
Time frame: Baseline and week 12
Change in sleep quality (PSQI)
Time frame: Baseline and week 12
Change in Mediterranean diet adherence (PREDIMED score)
Time frame: Baseline and week 12
Change in physical activity level (IPAQ questionnaire)
Time frame: Baseline and week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food Supplement Combination (SACIANS Formula) in people with Dyslipidemia and Lipid Metabolism, run by University of Alicante 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 5 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 16 Dec 2025. 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. 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 total cholesterol (time frame: Baseline and after 12 weeks of intervention). The study lists 6 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 16 Dec 2025.