Actively Recruiting
Multiomic Evaluation of Artichoke By-products Supplementation Rich in Hydroxycinnamic Acids with an Energy-restricted Mediterranean Diet for Preventing Type 2 Diabetes
Led by Clinica Universidad de Navarra, Universidad de Navarra · Updated on 2026-04-29
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Clinica Universidad de Navarra, Universidad de Navarra
Lead Sponsor
U
University of Navarra
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether taking a supplement made from artichoke by-products, which are rich in hydroxycinnamic acids (HCAs), alongside an energy-restricted Mediterranean diet can improve blood sugar control, reduce insulin resistance, and support weight loss in adults who are overweight or obese. The study also aims to understand the biological mechanisms involved using advanced techniques and to identify biomarkers that may help tailor personalized nutrition strategies for preventing type 2 diabetes. Participants will be randomly assigned to one of two groups for a 16-week period. One group will follow an energy-restricted Mediterranean diet combined with physical activity guidance and take daily capsules containing artichoke by-product powder rich in HCAs. The other group will follow the same diet and physical activity plan but will take placebo capsules without HCAs. Both groups will receive personalized dietary counselling and recommendations to engage in at least 150 minutes of moderate physical activity each week. During the study, participants will attend clinical visits to monitor diet and exercise adherence, collect biological samples, and evaluate health outcomes. Researchers will measure changes in insulin resistance using HOMA-IR, body weight, glucose metabolism markers, lipid profiles, inflammatory and oxidative stress markers, and continuous glucose monitoring data. They will also use advanced molecular analyses to study gut microbiota, metabolomics, and DNA methylation. The study will last 16 weeks, with outcomes assessed from enrollment to the end of the intervention period.
CONDITIONS
Brief Title
Artichoke By-products Rich in Hydroxycinnamic Acids and Mediterranean Diet for Type 2 Diabetes Prevention.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- BMI between 25.0 and 35.0 kg/m�b2
- HOMA-IR of 2.5 or higher
- Adequate physical exam and vital signs with no relevant concerns for metabolic health
- Ability to understand and sign the informed consent form
- Stable communication means via email or telephone
You will not qualify if you...
- Weight loss greater than 5% in the last 6 months
- Antibiotic use in the 3 months before the intervention
- Current treatment for weight loss or blood glucose control, or history of weight loss surgery
- Diagnosis of type 1 or type 2 diabetes
- History of inflammatory bowel disease or intestinal resection
- Inability to follow the diet or physical activity recommendations
- Unavailability for study visits
- Failure to sign informed consent
- Inability to communicate with the research team
- Endocrine-related excess weight except stable treated hypothyroidism
- Pregnancy or plans for pregnancy during the study
- Breastfeeding
- Allergy to artichokes
- Severe psychiatric illness requiring hospitalization in last 6 months
- Renal failure
- Immunodeficiency or HIV positive
- Use of immunosuppressive or cytotoxic drugs
- High alcohol intake (more than 14 units/week for women, 20 units/week for men)
- Participation in another randomized clinical trial
- Recent or ongoing drug treatment under 3 months or unstable
- Use of certain nutritional supplements unless discontinued as required
- Blood donation within 14 days before baseline
- Current or recent cancer treatment or remission under 5 years
- Any condition interfering with adherence to the intervention
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 16 weeks
Participants follow a 16-week energy-restricted Mediterranean diet combined with physical activity counselling and daily supplementation with either artichoke by-product capsules or placebo capsules.
Baseline and periodic clinical visits during the 16-week intervention
Trial Site Locations
Total: 1 location
1
University of Navarra
Pamplona, Navarre, Spain, 31008
Actively Recruiting
Research Team
I
Idoia Ibero, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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