Recruiting
Not applicable
Artichoke By-products Rich in Hydroxycinnamic Acids and Mediterranean Diet for Type 2 Diabetes Prevention.
Condition(s) studied
Diabete Type 2Obesity & OverweightInsulin Resistance Syndrome
Investigational drug(s) / intervention(s)
Artichoke by-product capsulesEnergy-restricted Mediterranean diet (erMeDiet)Placebo capsulesPhysical activity
Artichoke by-product capsules: The intervention group will consume artichoke by-product capsules for 16 weeks.
Energy-restricted Mediterranean diet (erMeDiet): All study participants will follow an energy-restricted Mediterranean diet (erMeDiet) for 16 weeks.
Placebo capsules: The control group will consume placebo capsules for 16 weeks.
Physical activity: Participants will receive a recommendation to engage in physical activity (at least 150 minutes/week of moderate physical activity) for 16 weeks.
Study 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.
Eligibility
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
* 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.
Primary outcome measure(s)
- Change in HOMA-IR and body weight — 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).
Trial sites (1)
| Facility | City | Region | Status |
|---|
| University of Navarra |
Pamplona |
Navarre |
Recruiting |
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