Artichoke By-products Rich in Hydroxycinnamic Acids and Mediterranean Diet for Type 2 Diabetes Prevention.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorClinica Universidad de Navarra, Universidad de Navarra

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Artichoke by-product capsules
  • Energy-restricted Mediterranean diet (erMeDiet)
  • Placebo capsules
  • Physical activity

Treatment groups

150 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Clinica Universidad de Navarra, Universidad de Navarra

Lead sponsor

University of Navarra

Collaborator

Hospital of Navarra

Collaborator