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

Prior treatment

• 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.
• Being treated with immunosuppressive drugs or cytotoxic agents.
• Volunteers undergoing drug treatment for less than 3 months with a stable dose/stable treatment.
• Taking nutritional supplements (supplements: plant derivatives, for weight loss, fibre and probiotics) unless the person is willing to stop taking them for 3 months prior to the start of the trial.
• Taking nutritional supplements (supplements: plant-derived, for weight loss, fibre and probiotics) unless the person is willing to stop taking them for the 16 weeks of the study intervention and a minimum washout period of 14 days prior to baseline measurements is guaranteed.
• Having donated blood in the 14 days prior to the baseline visit.

Other illness

• Have a medical diagnosis of type 1 or type 2 diabetes.
• History of inflammatory bowel disease and/or resection of the large or small intestine. Subjects with relevant functional or structural abnormalities of the digestive system.
• Failure to sign the informed consent form.
• Having an allergy to artichokes.
• Severe psychiatric illnesses that have required hospitalisation in the last 6 months.
• Renal failure.
• Having immunodeficiency or being HIV positive.
• Subjects with any type of cancer or undergoing treatment for cancer, or who have not been in remission for at least 5 years.
• Any other condition that may interfere with adherence to the intervention.

Lab values

• 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.

Other

• Inability to follow the recommended diet or physical exercise.
• Unavailability in terms of time or location to attend study visits.
• Inability to communicate with the research team.
• Endocrine-related excess weight (except for treated hypothyroidism, at least 3 months of stable treatment).
• Being pregnant or planning a pregnancy during the intervention period.
• Being breastfeeding.
• High alcohol intake: more than 14 units (women) and 20 units (men) per week.
• Participation in another randomised clinical trial.

• 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.
• Subjects must have a stable means of communication, either by email and/or telephone.