Artichoke By-products Rich in Hydroxycinnamic Acids and Mediterranean Diet for Type 2 Diabetes Pr… (NCT07415720) | Clinical Trial Compass
RecruitingNot Applicable
Artichoke By-products Rich in Hydroxycinnamic Acids and Mediterranean Diet for Type 2 Diabetes Prevention.
Spain150 participantsStarted 2026-05
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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 psy…
What they're measuring
1
Change in HOMA-IR and body weight
Timeframe: From enrollment to the end of treatment at 16 weeks.
Trial details
NCT IDNCT07415720
SponsorClinica Universidad de Navarra, Universidad de Navarra