Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
Healthy Volunteers
NCT07415720

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

Led by Clinica Universidad de Navarra, Universidad de Navarra · Updated on 2026-04-29

150

Participants Needed

1

Research Sites

82 weeks

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

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • BMI between 25.0 and 35.0 kg/m8
  • HOMA-IR 6 2.5
  • Adequate physical examination and vital signs or clinically irrelevant to the intervention
  • Ability to understand and sign informed consent
  • Stable communication via email and/or telephone
Not Eligible

You will not qualify if you...

  • Weight loss greater than 5% in the last 6 months
  • Antibiotic use in the 3 months before intervention
  • Current treatment for weight loss or body composition modification
  • Use of medication for weight loss or blood glucose control
  • History of weight loss surgery
  • Diagnosis of type 1 or type 2 diabetes
  • History of inflammatory bowel disease or intestinal resection
  • Functional or structural digestive system abnormalities
  • Inability to follow recommended diet or physical exercise
  • Unavailability to attend study visits
  • Failure to sign informed consent
  • Inability to communicate with research team
  • Endocrine-related excess weight except treated hypothyroidism
  • Pregnancy or planning pregnancy during intervention
  • Breastfeeding
  • Allergy to artichokes
  • Severe psychiatric illness requiring hospitalization in last 6 months
  • Renal failure
  • Immunodeficiency or HIV positive
  • Treatment with 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 drug treatment less than 3 months with unstable dose
  • Taking nutritional supplements unless willing to stop before and during study
  • Blood donation within 14 days prior to baseline visit
  • Current or recent cancer treatment or less than 5 years remission
  • Other conditions interfering with adherence to intervention

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Navarra

Pamplona, Navarre, Spain, 31008

Actively Recruiting

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Research Team

I

Idoia Ibero, PhD

CONTACT

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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