RecruitingNot ApplicableNCT07198789

Randomized, Double-blind Crossover Trial Comparing Low-GI Functional vs. Standard Wholegrain Carbohydrates on Glycolipid Metabolism and Vascular Stress Markers in Adults With Suboptimal Triglyceridemia

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


Sponsor

University of Bologna

Enrollment

40 participants

Start Date

Feb 2, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

Low-glycemic index (GI) carbohydrates help prevent type 2 diabetes and cardiovascular disease by reducing postprandial glucose, insulin spikes, inflammation, and triglyceride synthesis. They improve weight, lipid profiles, and vascular health. Our study will compare functional low-GI vs. standard wholegrain carbs in a Mediterranean diet to assess their effect on the Triglycerides-Glucose Index, a marker of metabolic and cardiovascular risk, in subjects with suboptimal triglyceride levels.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria4

  • 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.

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Interventions

OTHERAltograno® Bakery Foods

Altograno® Pasta, Pizza and Flatbrad, in substitution of the same amount of carbohydrates usually eaten in a stabilized diet

OTHERStandard Whole-Grain Bakery Foods

Industrial standard whole-grain Pasta, Pizza and Flatbrad, in substitution of the same amount of carbohydrates usually eaten in a stabilized diet


Locations(1)

Cardiovascular Internal Medicine Unit, IRCCS University Hospital of Bologna, Bologna, Italy

Bologna, BO, Italy

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NCT07198789


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