The ARTI-UP study evaluates whether daily consumption of a supplement made from artichoke by-products, rich in hydroxycinnamic acids (HCAs), in combination with an energy-restricted Mediterranean diet (erMeDiet), can improve glycaemic control, reduce insulin resistance and contribute to weight loss in subjects with overweight or obesity. In addition, it seeks to understand the biological mechanisms involved using omic techniques and to establish predictive biomarkers that will enable progress towards personalised nutrition strategies.
BMI between 25.0 and 35.0 kg/m²
HOMA-IR ≥ 2.5.
Adequate physical examination and vital signs or clinically irrelevant to the intervention (those not related to metabolic health).
Subjects must be able to understand and be willing to sign the informed consent form, and must comply with all study procedures and requirements.
Weight loss of more than 5% in the last 6 months prior to surgery.
Consumption of antibiotics in the 3 months prior to the intervention.
Subjects who are undergoing treatment for weight loss/body composition modification, use medication for weight loss or blood glucose control, or have had weight loss surgery.
Have a medical diagnosis of type 1 or type 2 diabetes.
Parallel
Artichoke by-product capsules
Dietary supplementThe intervention group will consume artichoke by-product capsules for 16 weeks.
Energy-restricted Mediterranean diet (erMeDiet)
BehavioralAll study participants will follow an energy-restricted Mediterranean diet (erMeDiet) for 16 weeks.
Placebo capsules
Dietary supplementThe control group will consume placebo capsules for 16 weeks.
Physical activity
BehavioralParticipants will receive a recommendation to engage in physical activity (at least 150 minutes/week of moderate physical activity) for 16 weeks.
Change in HOMA-IR and body weight
Formula: fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5 30. HOMA-IR is a good measurement of insulin resistance since it has a very good correlation with the gold standard test hyperinsulinemic-euglycemic clamp (r\>0.88, p\<0.0001).
Fasting glucose (mmol/L)
Concentration of glucose in venous blood measured after an overnight fast of at least 8 hours, expressed in millimoles per liter (mmol/L). It reflects basal glycemic control and is used to assess glucose metabolism and risk of type 2 diabetes.
Fasting insulin (µU/mL)
Concentration of insulin in venous blood measured after an overnight fast of at least 8 hours, expressed in micro-units per milliliter (µU/mL). It reflects basal insulin secretion and is used to evaluate insulin sensitivity and resistance.
HbA1c (%)
Percentage of glycated hemoglobin in whole blood, reflecting the average blood glucose concentration over the previous 2-3 months. It is used to assess long-term glycemic control and risk of type 2 diabetes.
HOMA-IR Index
The HOMA-IR (Homeostatic Model Assessment of Insulin Resistance) index is a diagnostic tool used to measure insulin resistance and beta-cell function by evaluating the relationship between fasting plasma insulin (FPI) and fasting plasma glucose (FPG).
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Clinica Universidad de Navarra, Universidad de Navarra
Lead sponsor
University of Navarra
Collaborator
Hospital of Navarra
Collaborator
