Functional low‑GI versus standard wholegrain carbohydrates for adults with moderately high triglycerides
Official title: Randomized, Double-Blind, Placebo-Controlled Crossover Clinical Trial to Evaluate the Effect of a Functional Low-Glycemic Index Carbohydrates Versus Standard Wholegrain Carbohydrates on Glycolipid Metabolism and Vascular Stress Markers in Subjects With Suboptimal Triglyceridemia
Run by University of Bologna · NCT07198789 · Data updated 2026-11-12
This study will test whether swapping standard wholegrain carbs for functional low‑GI bakery foods within a Mediterranean diet helps improve the triglyceride‑glucose index and vascular stress markers in adults with suboptimal triglyceride levels.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | University of Bologna Academic / other |
| Locations | 1 site (Bologna, BO) |
| Status | Recruiting |
| Started | February 2, 2026 |
| Main results expected | September 29, 2026 |
| Study ends | September 29, 2026 |
| Registry record updated | May 1, 2026 |
| Trial ID | NCT07198789 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older with fasting triglycerides >150 mg/dL who can attend visits at the Bologna clinic and are not living with celiac disease or BMI over 30 are ideal candidates.
✕Probably not a fit
People with BMI >30 kg/m2, diagnosed gluten hypersensitivity/coeliac disease, or those on recently changed preventive medications are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, double‑blind, crossover trial comparing a functional low‑glycemic‑index (Altograno®) bakery intervention with standard wholegrain bakery foods, both delivered as part of a Mediterranean dietary pattern. Adults with triglycerides over 150 mg/dL will follow each diet arm for a defined period with washout between arms, while researchers measure the Triglycerides‑Glucose Index and blood markers of vascular stress and inflammation. The crossover design means each participant receives both interventions in random order, which increases within‑person comparison power. Key exclusions include celiac disease, BMI over 30 kg/m2, and unstable preventive medications.
Why it matters
Potential benefit: If successful, the intervention could modestly lower metabolic risk markers and reduce long‑term risk for diabetes and cardiovascular disease.
How similar studies have gone: Previous randomized and cohort studies of low‑GI diets have shown modest improvements in fasting glucose, HbA1c and lipid measures, so this dietary approach has supporting evidence though results are incremental.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female aged ≥ 18 years * TG\>150 mg/dL * Subjects who have the capability to communicate and to comply with the study's requirements. * Subjects agree to participate in the study and having dated and signed the informed consent form. Exclusion Criteria: * Gluten hypersensitivity/Coeliac disease diagnosis * BMI\>30 kg/m2 * Any preventive treatments (i.e. lipid-lowering drugs, antihypertensives) not stabilized in type and dose for at least 3 months * Any medical or surgical condition that would limit the patient adhesion to the study protocol.
Where it's running
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Cardiovascular Internal Medicine Unit, IRCCS University Hospital of Bologna, Bologna, Italy
Bologna, Bo, Italy Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.