NCT07415720

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
17mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress8%
May 2026Dec 2027

First Submitted

Initial submission to the registry

January 20, 2026

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 17, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

1.6 years

First QC Date

January 20, 2026

Last Update Submit

April 28, 2026

Conditions

Diabete Type 2Obesity & OverweightInsulin Resistance Syndrome

Outcome Measures

Primary Outcomes (1)

  • Change in HOMA-IR and body weight

    Formula: fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5 30. HOMA-IR is a good measurement of insulin resistance since it has a very good correlation with the gold standard test hyperinsulinemic-euglycemic clamp (r\>0.88, p\<0.0001).

    From enrollment to the end of treatment at 16 weeks.

Secondary Outcomes (35)

  • Fasting glucose (mmol/L)

    From enrollment to the end of treatment at 16 weeks.

  • Fasting insulin (µU/mL)

    From enrollment to the end of treatment at 16 weeks.

  • HbA1c (%)

    From enrollment to the end of treatment at 16 weeks.

  • HOMA-IR Index

    From enrollment to the end of treatment at 16 weeks.

  • HOMA-B index

    From enrollment to the end of treatment at 16 weeks.

  • +30 more secondary outcomes

Study Arms (2)

Intervention group: erMeDiet + artichoke capsules

EXPERIMENTAL

Participants will follow a energy-restricted Mediterranean diet and consume artichoke by-product capsules daily for 16 weeks.

Dietary Supplement: Artichoke by-product capsulesBehavioral: Energy-restricted Mediterranean diet (erMeDiet)Behavioral: Physical activity

Control group: erMeDiet + placebo capsules

PLACEBO COMPARATOR

Participants will follow an energy-restricted Mediterranean diet and consume placebo capsules daily for 16 weeks.

Behavioral: Energy-restricted Mediterranean diet (erMeDiet)Dietary Supplement: Placebo capsulesBehavioral: Physical activity

Interventions

Energy-restricted Mediterranean diet (erMeDiet)BEHAVIORAL

All study participants will follow an energy-restricted Mediterranean diet (erMeDiet) for 16 weeks.

Control group: erMeDiet + placebo capsulesIntervention group: erMeDiet + artichoke capsules
Physical activityBEHAVIORAL

Participants will receive a recommendation to engage in physical activity (at least 150 minutes/week of moderate physical activity) for 16 weeks.

Control group: erMeDiet + placebo capsulesIntervention group: erMeDiet + artichoke capsules
Artichoke by-product capsulesDIETARY_SUPPLEMENT

The intervention group will consume artichoke by-product capsules for 16 weeks.

Intervention group: erMeDiet + artichoke capsules
Placebo capsulesDIETARY_SUPPLEMENT

The control group will consume placebo capsules for 16 weeks.

Control group: erMeDiet + placebo capsules

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Navarra

Pamplona, Navarre, 31008, Spain

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2ObesityOverweightMetabolic Syndrome

Interventions

Exercise

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinism

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Sonia García-Calzón, PhD

    University of Navarra

    PRINCIPAL INVESTIGATOR

  • Iziar Ludwig, PhD

    University of Navarra

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Idoia Ibero, PhD

CONTACT

+34 948 425 744iibero@unav.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 20, 2026

First Posted

February 17, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

April 29, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)