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

NCT07269795 | Completed

• 1 other identifier: UA-2025-04-15
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

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

Keywords

Food supplements; Satiety; Lipid metabolism; Overweight; Middle-aged adults; Metabolic health; Nutraceuticals; Mediterranean diet; Body composition

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (10)

• Change in body weight

  Baseline and after 12 weeks of intervention

• Change in body fat percentage

  Baseline and after 12 weeks of intervention

• Change in lean mass

  Baseline and after 12 weeks of intervention

• Change in C-reactive protein (CRP)

  Baseline and after 12 weeks of intervention

• Change in malondialdehyde (MDA)

  Baseline and week 12

Study Arms (2)

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.

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.

Interventions

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.

Experimental Group - Food Supplement Combination

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alicante: lead

Study Sites (1)

European Institute Of Exercise and Health

Elche, Alicante, 03203, Spain

Location

MeSH Terms

Conditions

Dyslipidemias; Overweight

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor will be blinded to group allocation during data analysis to minimize bias. Given the nature of the intervention (supplementation vs. no supplementation), participant blinding is not applicable.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Catedrático Ciencias de la Salud

Model Details: 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.

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 8, 2025
• Study Start: September 1, 2024
• Primary Completion: August 30, 2025
• Study Completion: August 30, 2025
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)