Diabete Type 2ARTI-UPNCT07415720
Artichoke By-products Rich in Hydroxycinnamic Acids and Mediterranean Diet for Type 2 Diabetes Prevention.
A study testing Artichoke by-product capsules, Energy-restricted Mediterranean diet (erMeDiet) and Physical activity in people with Diabete Type 2 and Obesity & Overweight, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabete Type 2, Obesity & Overweight, Insulin Resistance Syndrome
- What is being tested?
- Artichoke by-product capsules, Energy-restricted Mediterranean diet (erMeDiet) and Physical activity
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- May 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 25Show fewer
- 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.
- Having immunodeficiency or being HIV positive.
- Being treated with immunosuppressive drugs or cytotoxic agents.
- High alcohol intake: more than 14 units (women) and 20 units (men) per week.
- Participation in another randomised clinical trial.
- Volunteers undergoing drug treatment for less than 3 months with a stable dose/stable treatment.
- Taking nutritional supplements (supplements: plant derivatives, for weight loss, fibre and probiotics) unless the person is willing to stop taking them for 3 months prior to the start of the trial.
- Taking nutritional supplements (supplements: plant-derived, for weight loss, fibre and probiotics) unless the person is willing to stop taking them for the 16 weeks of the study intervention and a minimum washout period of 14 days prior to baseline measurements is guaranteed.
- Having donated blood in the 14 days prior to the baseline visit.
- Subjects with any type of cancer or undergoing treatment for cancer, or who have not been in remission for at least 5 years.
- Any other condition that may interfere with adherence to the intervention.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
University of Navarra
Pamplona, Navarre, 31008
Idoya Ibero Baraibar, +34948425600, iibero@unav.es
About this study
Official title: Multiomic Evaluation of the Effect of Artichoke By-products Supplementation Rich in Hydroxycinnamic Acids, Integrated Into an Energy-restricted Mediterranean Diet, on the Prevention of Type 2 Diabetes.
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.
Read the detailed description
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.
- Being tested
- Artichoke by-product capsules, Energy-restricted Mediterranean diet (erMeDiet), Placebo capsules, Physical activity
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Overweight, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artichoke by-product capsulesDietary supplement
The intervention group will consume artichoke by-product capsules for 16 weeks.
Energy-restricted Mediterranean diet (erMeDiet)Behavioural
All study participants will follow an energy-restricted Mediterranean diet (erMeDiet) for 16 weeks.
Placebo capsulesDietary supplement
The control group will consume placebo capsules for 16 weeks.
Physical activityBehavioural
Participants will receive a recommendation to engage in physical activity (at least 150 minutes/week of moderate physical activity) for 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group: erMeDiet + artichoke capsules | Experimental | Participants will follow a energy-restricted Mediterranean diet and consume artichoke by-product capsules daily for 16 weeks. Receives: Dietary Supplement: Artichoke by-product capsules; Behavioral: 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. Receives: Behavioral: Energy-restricted Mediterranean diet (erMeDiet); Dietary Supplement: Placebo capsules; Behavioral: Physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From enrollment to the end of treatment at 16 weeks.
Secondary outcomes (35)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: From enrollment to the end of treatment at 16 weeks.
Urinary metabolomic profile
Relative abundance of urinary metabolites identified by metabolomic analysis.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: From enrollment to the end of treatment at 16 weeks.
Waist circumference (cm)
Measured to evaluate central adiposity and cardiometabolic risk.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of treatment at 16 weeks.
Total cholesterol (mmol/L)
Measured enzymatically to assess lipid metabolism and cardiovascular risk.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of treatment at 16 weeks.
Triglycerides (mmol/L)
Measured enzymatically as an indicator of lipid metabolism and metabolic health.
Measured: From enrollment to the end of treatment at 16 weeks.
C-reactive protein (CRP) (mg/L)
Measured to assess systemic low-grade inflammation.
Measured: 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.
Measured: From enrollment to the end of treatment at 16 weeks.
Interleukin-6 (IL-6) (pg/mL)
Measured by ELISA to assess inflammatory signaling.
Measured: 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.
Measured: From enrollment to the end of treatment at 16 weeks.
Alanine transaminase (ALT) (U/L)
Measured to assess hepatocellular function.
Measured: From enrollment to the end of treatment at 16 weeks.
Aspartate aminotransferase (AST) (U/L)
Measured to assess liver and metabolic health.
Measured: 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.
Measured: From enrollment to the end of treatment at 16 weeks.
Blood urea (mmol/L)
Measured to assess renal function and protein metabolism.
Measured: From enrollment to the end of treatment at 16 weeks.
Blood creatinine (µmol/L)
Measured to assess renal filtration capacity.
Measured: 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.
Measured: From enrollment to the end of treatment at 16 weeks.
Blood albumin (g/L)
Measured as an indicator of nutritional and inflammatory status.
Measured: From enrollment to the end of treatment at 16 weeks.
Uric acid (µmol/L)
Measured to assess purine metabolism and cardiometabolic risk.
Measured: 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.
Measured: From enrollment to the end of treatment at 16 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study startMay 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Collaborators
- University of Navarra, Hospital of Navarra
- Responsible party
- Principal investigator, Sonia García Calzón, Clinica Universidad de Navarra, Universidad de Navarra
- Investigators
- Sonia García-Calzón, PhD, Principal investigator, University of NavarraIziar Ludwig, PhD, Principal investigator, University of Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07415720
- Sponsor's protocol ID
- ARTI-UP
- Acronym
- ARTI-UP
- Status last verified
- Apr 2026
- First submitted
- 20 Jan 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiomic Evaluation of the Effect of Artichoke By-products Supplementation Rich in Hydroxycinnamic Acids, Integrated Into an Energy-restricted Mediterranean Diet, on the Prevention of Type 2 Diabetes.
- ClinicalTrials.gov ID
- NCT07415720
- Acronym / sponsor ID
- ARTI-UP / ARTI-UP
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Collaborators
- University of Navarra, Hospital of Navarra
- Study start
- May 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group: erMeDiet + artichoke capsules | Experimental | Dietary Supplement: Artichoke by-product capsules, Behavioral: Energy-restricted Mediterranean diet (erMeDiet), Behavioral: Physical activityParticipants will follow a energy-restricted Mediterranean diet and consume artichoke by-product capsules daily for 16 weeks. |
| Control group: erMeDiet + placebo capsules | Placebo comparator | Behavioral: Energy-restricted Mediterranean diet (erMeDiet), Dietary Supplement: Placebo capsules, Behavioral: Physical activityParticipants will follow an energy-restricted Mediterranean diet and consume placebo capsules daily for 16 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artichoke by-product capsulesThe intervention group will consume artichoke by-product capsules for 16 weeks. | Dietary supplement | Intervention group: erMeDiet + artichoke capsules |
| Energy-restricted Mediterranean diet (erMeDiet)All study participants will follow an energy-restricted Mediterranean diet (erMeDiet) for 16 weeks. | Behavioural | Control group: erMeDiet + placebo capsules, Intervention group: erMeDiet + artichoke capsules |
| Placebo capsulesThe control group will consume placebo capsules for 16 weeks. | Dietary supplement | Control group: erMeDiet + placebo capsules |
| Physical activityParticipants will receive a recommendation to engage in physical activity (at least 150 minutes/week of moderate physical activity) for 16 weeks. | Behavioural | Control group: erMeDiet + placebo capsules, Intervention group: erMeDiet + artichoke capsules |
Primary outcome
Change in HOMA-IR and body weight
Time frame: From enrollment to the end of treatment at 16 weeks.
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).
35 secondary outcomes
Fasting glucose (mmol/L)
Time frame: From enrollment to the end of treatment at 16 weeks.
Fasting insulin (µU/mL)
Time frame: From enrollment to the end of treatment at 16 weeks.
HbA1c (%)
Time frame: From enrollment to the end of treatment at 16 weeks.
HOMA-IR Index
Time frame: From enrollment to the end of treatment at 16 weeks.
HOMA-B index
Time frame: From enrollment to the end of treatment at 16 weeks.
Gut microbial diversity
Time frame: From enrollment to the end of treatment at 16 weeks.
Gut microbiota taxonomic composition
Time frame: From enrollment to the end of treatment at 16 weeks.
Microbial functional pathways related to metabolic health
Time frame: From enrollment to the end of treatment at 16 weeks.
Urinary polyphenol-derived metabolites (mmol/24 h).
Time frame: From enrollment to the end of treatment at 16 weeks.
Urinary metabolomic profile
Time frame: From enrollment to the end of treatment at 16 weeks.
Epigenome-wide DNA methylation analysis
Time frame: From enrollment to the end of treatment at 16 weeks.
Differentially methylated CpG sites (Δβ-value)
Time frame: From enrollment to the end of treatment at 16 weeks.
Epigenetic age acceleration (years)
Time frame: From enrollment to the end of treatment at 16 weeks.
Body Mass Index (BMI) (kg/m²)
Time frame: From enrollment to the end of treatment at 16 weeks.
Waist circumference (cm)
Time frame: From enrollment to the end of treatment at 16 weeks.
Fat mass (kg)
Time frame: From enrollment to the end of treatment at 16 weeks.
Fat mass (%)
Time frame: From enrollment to the end of treatment at 16 weeks.
Visceral Adipose Tissue (VAT) (g or cm²)
Time frame: From enrollment to the end of treatment at 16 weeks.
Total cholesterol (mmol/L)
Time frame: From enrollment to the end of treatment at 16 weeks.
Low-density lipoprotein cholesterol (LDL-c) (mmol/L)
Time frame: From enrollment to the end of treatment at 16 weeks.
High-density lipoprotein cholesterol (HDL-c) (mmol/L)
Time frame: From enrollment to the end of treatment at 16 weeks.
Triglycerides (mmol/L)
Time frame: From enrollment to the end of treatment at 16 weeks.
C-reactive protein (CRP) (mg/L)
Time frame: From enrollment to the end of treatment at 16 weeks.
Tumor necrosis factor-alpha (TNF-α) (pg/mL)
Time frame: From enrollment to the end of treatment at 16 weeks.
Interleukin-6 (IL-6) (pg/mL)
Time frame: From enrollment to the end of treatment at 16 weeks.
Oxidized LDL (LDLox) (U/L)
Time frame: From enrollment to the end of treatment at 16 weeks.
Alanine transaminase (ALT) (U/L)
Time frame: From enrollment to the end of treatment at 16 weeks.
Aspartate aminotransferase (AST) (U/L)
Time frame: From enrollment to the end of treatment at 16 weeks.
Gamma-glutamyl transpeptidase (GGT) (U/L)
Time frame: From enrollment to the end of treatment at 16 weeks.
Blood urea (mmol/L)
Time frame: From enrollment to the end of treatment at 16 weeks.
Blood creatinine (µmol/L)
Time frame: From enrollment to the end of treatment at 16 weeks.
Estimated Glomerular Filtration Rate (eGFR) (mL/min/1.73 m²)
Time frame: From enrollment to the end of treatment at 16 weeks.
Blood albumin (g/L)
Time frame: From enrollment to the end of treatment at 16 weeks.
Uric acid (µmol/L)
Time frame: From enrollment to the end of treatment at 16 weeks.
Total intervention adherence (%)
Time frame: From enrollment to the end of treatment at 16 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sonia García-Calzón, PhD principal investigator
University of Navarra
Iziar Ludwig, PhD principal investigator
University of Navarra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artichoke by-product capsules, Energy-restricted Mediterranean diet (erMeDiet) and Physical activity in people with Diabete Type 2 and Obesity & Overweight, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Idoia Ibero, PhD (+34 948 425 744, iibero@unav.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HOMA-IR and body weight (time frame: From enrollment to the end of treatment at 16 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.