An interventional study of Artichoke by-product capsules and Energy-restricted Mediterranean diet (erMeDiet) in Diabete Type 2, Obesity & Overweight and Insulin Resistance Syndrome, sponsored by Clinica Universidad de Navarra, Universidad de Navarra. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-29.
Sponsored by Clinica Universidad de Navarra, Universidad de Navarra · Not applicable, Interventional, and Prevention
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.
Type 2 diabetes (T2D) and obesity represent major global public health challenges, largely driven by insulin resistance and excess body weight. Lifestyle interventions based on energy-restricted Mediterranean dietary patterns have demonstrated beneficial effects on glycemic control and body weight; however, substantial interindividual variability in response persists. Emerging evidence suggests that specific dietary bioactive compounds, such as hydroxycinnamic acids (HCAs), may play a relevant role in improving insulin sensitivity, yet their contribution within structured dietary interventions remains insufficiently explored.
In this context, the hypothesis of the present study is that daily supplementation with an artichoke by-product powder rich in bioavailable HCAs, administered within an energy-restricted Mediterranean diet (erMeDiet), will lead to greater improvements in insulin resistance and body weight compared with an erMeDiet alone in overweight and obese adults with insulin resistance. Furthermore, interindividual variability in response to HCAs is hypothesized to be partially explained by differences in metabolic, microbiota-related, and epigenetic profiles.
Following recruitment and screening, the study will consist of a 16-week randomized, controlled, double-blind, parallel-group lifestyle intervention. Participants will be randomly assigned (1:1) to one of two intervention arms:
Intervention group: Energy-restricted Mediterranean diet (approximately -500 kcal/day) combined with physical activity counselling and daily supplementation with an artichoke by-product powder providing a minimum of 600 mg/day of bioavailable hydroxycinnamic acids.
Control group: Energy-restricted Mediterranean diet and identical physical activity counselling, supplemented with an isocaloric placebo powder matched for macronutrient composition but devoid of HCAs.
All participants will receive individualized dietary counselling and guidance to achieve at least 150 minutes per week of moderate-intensity physical activity. Clinical visits will be conducted at baseline and throughout the intervention to monitor adherence, collect biological samples, and assess outcomes.
The primary outcomes of the study are changes in insulin resistance, assessed by the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), and changes in body weight after 16 weeks of intervention. Secondary outcomes include changes in anthropometric parameters, glucose metabolism markers, lipid profile, inflammatory and oxidative stress markers, dietary intake, physical activity, and continuous glucose monitoring metrics.
In addition, a comprehensive multi-omics approach will be applied to investigate the biological mechanisms underlying the effects of HCAs. This includes targeted and untargeted metabolomics, gut microbiota metagenomics, and genome-wide DNA methylation analyses. Machine learning methods will be used to integrate clinical and omics data in order to identify biomarkers predictive of individual response to the intervention, contributing to the advancement of precision nutrition strategies for T2D prevention.
This study aims to provide robust clinical and mechanistic evidence supporting the use of sustainable, upcycled plant-based bioactive compounds as complementary dietary tools for improving insulin resistance and preventing type 2 diabetes in high-risk populations.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 150 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Clinica Universidad de Navarra, Universidad de Navarra is the lead sponsor of 160 studies on the registry; 36 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will follow a energy-restricted Mediterranean diet and consume artichoke by-product capsules daily for 16 weeks.
Dietary Supplement: Artichoke by-product capsules · Behavioral: Energy-restricted Mediterranean diet (erMeDiet) · Behavioral: Physical activity
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 capsules · Behavioral: Physical activity
The intervention group will consume artichoke by-product capsules for 16 weeks.
All study participants will follow an energy-restricted Mediterranean diet (erMeDiet) for 16 weeks.
The control group will consume placebo capsules for 16 weeks.
Participants will receive a recommendation to engage in physical activity (at least 150 minutes/week of moderate physical activity) for 16 weeks.
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).
Time frame: From enrollment to the end of treatment at 16 weeks.
Fasting glucose (mmol/L)
Concentration of glucose in venous blood measured after an overnight fast of at least 8 hours, expressed in millimoles per liter (mmol/L). It reflects basal glycemic control and is used to assess glucose metabolism and risk of type 2 diabetes.
Time frame: From enrollment to the end of treatment at 16 weeks.
Fasting insulin (µU/mL)
Concentration of insulin in venous blood measured after an overnight fast of at least 8 hours, expressed in micro-units per milliliter (µU/mL). It reflects basal insulin secretion and is used to evaluate insulin sensitivity and resistance.
Time frame: From enrollment to the end of treatment at 16 weeks.
HbA1c (%)
Percentage of glycated hemoglobin in whole blood, reflecting the average blood glucose concentration over the previous 2-3 months. It is used to assess long-term glycemic control and risk of type 2 diabetes.
Time frame: From enrollment to the end of treatment at 16 weeks.
HOMA-IR Index
The HOMA-IR (Homeostatic Model Assessment of Insulin Resistance) index is a diagnostic tool used to measure insulin resistance and beta-cell function by evaluating the relationship between fasting plasma insulin (FPI) and fasting plasma glucose (FPG).
Time frame: From enrollment to the end of treatment at 16 weeks.
HOMA-B index
An index estimating pancreatic β-cell function derived from fasting glucose and fasting insulin concentrations using the Homeostasis Model Assessment (HOMA) method. It reflects basal insulin secretory capacity.
Time frame: From enrollment to the end of treatment at 16 weeks.
Gut microbial diversity
Alpha diversity indices (e.g., Shannon, Simpson) and beta diversity metrics to assess overall community structure changes.
Time frame: From enrollment to the end of treatment at 16 weeks.
Gut microbiota taxonomic composition
Relative abundance of gut microbiota bacterial taxa at different phylogenetic levels and their changes over time between intervention groups.
Time frame: From enrollment to the end of treatment at 16 weeks.
Microbial functional pathways related to metabolic health
Abundance of microbial metabolic pathways related to short-chain fatty acid production, polyphenol metabolism, and inflammation.
Time frame: From enrollment to the end of treatment at 16 weeks.
Urinary polyphenol-derived metabolites (mmol/24 h).
24-hour urinary excretion of polyphenol metabolites (e.g., phenolic acids).
Time frame: From enrollment to the end of treatment at 16 weeks.
Urinary metabolomic profile
Relative abundance of urinary metabolites identified by metabolomic analysis.
Time frame: From enrollment to the end of treatment at 16 weeks.
Epigenome-wide DNA methylation analysis
DNA methylation analysis will be performed using genomic DNA extracted from peripheral blood buffy coat samples.
Time frame: From enrollment to the end of treatment at 16 weeks.
Differentially methylated CpG sites (Δβ-value)
Differences in the change of DNA methylation at CpG sites between intervention groups.
Time frame: From enrollment to the end of treatment at 16 weeks.
Epigenetic age acceleration (years)
Epigenetic age acceleration estimated from DNA methylation clocks. Unit: Years (difference between epigenetic biological age and chronological age).
Time frame: From enrollment to the end of treatment at 16 weeks.
Body Mass Index (BMI) (kg/m²)
Calculated as body weight divided by height squared to assess overall adiposity.
Time frame: From enrollment to the end of treatment at 16 weeks.
Waist circumference (cm)
Measured to evaluate central adiposity and cardiometabolic risk.
Time frame: From enrollment to the end of treatment at 16 weeks.
Fat mass (kg)
Assessed by dual-energy X-ray absorptiometry (DEXA) to quantify total body fat.
Time frame: From enrollment to the end of treatment at 16 weeks.
Fat mass (%)
Assessed by dual-energy X-ray absorptiometry (DEXA) to quantify percentage of body fat.
Time frame: From enrollment to the end of treatment at 16 weeks.
Visceral Adipose Tissue (VAT) (g or cm²)
Assessed by dual-energy X-ray absorptiometry (DEXA) to quantify visceral fat mass as an indicator of cardiometabolic risk.
Time frame: From enrollment to the end of treatment at 16 weeks.
Total cholesterol (mmol/L)
Measured enzymatically to assess lipid metabolism and cardiovascular risk.
Time frame: From enrollment to the end of treatment at 16 weeks.
Low-density lipoprotein cholesterol (LDL-c) (mmol/L)
Measured enzymatically as a marker of atherogenic lipid particles.
Time frame: From enrollment to the end of treatment at 16 weeks.
High-density lipoprotein cholesterol (HDL-c) (mmol/L)
Measured enzymatically as a marker of cardioprotective lipid fraction.
Time frame: From enrollment to the end of treatment at 16 weeks.
Triglycerides (mmol/L)
Measured enzymatically as an indicator of lipid metabolism and metabolic health.
Time frame: From enrollment to the end of treatment at 16 weeks.
C-reactive protein (CRP) (mg/L)
Measured to assess systemic low-grade inflammation.
Time frame: From enrollment to the end of treatment at 16 weeks.
Tumor necrosis factor-alpha (TNF-α) (pg/mL)
Measured by ELISA to assess pro-inflammatory cytokine activity.
Time frame: From enrollment to the end of treatment at 16 weeks.
Interleukin-6 (IL-6) (pg/mL)
Measured by ELISA to assess inflammatory signaling.
Time frame: From enrollment to the end of treatment at 16 weeks.
Oxidized LDL (LDLox) (U/L)
Measured by ELISA as a marker of oxidative stress and atherogenic risk.
Time frame: From enrollment to the end of treatment at 16 weeks.
Alanine transaminase (ALT) (U/L)
Measured to assess hepatocellular function.
Time frame: From enrollment to the end of treatment at 16 weeks.
Aspartate aminotransferase (AST) (U/L)
Measured to assess liver and metabolic health.
Time frame: From enrollment to the end of treatment at 16 weeks.
Gamma-glutamyl transpeptidase (GGT) (U/L)
Measured to assess liver function and oxidative stress status.
Time frame: From enrollment to the end of treatment at 16 weeks.
Blood urea (mmol/L)
Measured to assess renal function and protein metabolism.
Time frame: From enrollment to the end of treatment at 16 weeks.
Blood creatinine (µmol/L)
Measured to assess renal filtration capacity.
Time frame: From enrollment to the end of treatment at 16 weeks.
Estimated Glomerular Filtration Rate (eGFR) (mL/min/1.73 m²)
Estimated glomerular filtration rate will be calculated to assess renal function using serum creatinine, age, and sex. eGFR will be estimated using the CKD-EPI equation based on serum creatinine concentration.
Time frame: From enrollment to the end of treatment at 16 weeks.
Blood albumin (g/L)
Measured as an indicator of nutritional and inflammatory status.
Time frame: From enrollment to the end of treatment at 16 weeks.
Uric acid (µmol/L)
Measured to assess purine metabolism and cardiometabolic risk.
Time frame: From enrollment to the end of treatment at 16 weeks.
Total intervention adherence (%)
Calculated as the percentage of the prescribed intervention consumed during the study period, based on returned product counts and/or predefined adherence criteria.
Time frame: From enrollment to the end of treatment at 16 weeks.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for May 2026; primary completion for Dec 2027, 19 months later.
Of 2,066 non-industry interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's planned 19 months is close to that.
Counting every sponsor, half of 2,243 studies reached it within 21 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Clinica Universidad de Navarra, Universidad de Navarra →