Artichoke by-product supplement with an energy-restricted Mediterranean diet to prevent type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind, parallel-group 16-week trial will assign adults with overweight or obesity and insulin resistance (HOMA-IR ≥ 2.5) to an energy-restricted Mediterranean diet plus either artichoke by-product capsules rich in hydroxycinnamic acids (HCAs) or matched placebo. Primary outcomes include changes in glycaemic control, insulin resistance and body weight, and participants receive dietary counseling and physical activity advice throughout. The study will apply metabolomics, microbiome and epigenetic (omic) techniques to explore biological mechanisms and identify predictive biomarkers of response. The goal is to see if adding an HCA-rich supplement produces greater metabolic improvements than diet alone and to inform more personalized nutrition strategies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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.
* Inability to follow the recommended diet or physical exercise.
* Unavailability in terms of time or location to attend study visits.
* Failure to sign the informed consent form.
* 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.
* 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.
* Being treated with immunosuppressive drugs or cytotoxic agents.
* High alcohol intake: more than 14 units (women) and 20 units (men) per week.
* Participation in another randomised clinical trial.
* 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.
* 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.

Where it's running

• University of Navarra
  Pamplona, Navarre, Spain Recruiting

Study contacts

• Principal investigator: Sonia García-Calzón, PhD — University of Navarra
• Study coordinator: Idoia Ibero, PhD
• Email: iibero@unav.es
• Phone: +34 948 425 744

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.