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 range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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