About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Altograno® Bakery Foods
Other interventionAltograno® Pasta, Pizza and Flatbrad, in substitution of the same amount of carbohydrates usually eaten in a stabilized diet
Standard Whole-Grain Bakery Foods
Other interventionIndustrial standard whole-grain Pasta, Pizza and Flatbrad, in substitution of the same amount of carbohydrates usually eaten in a stabilized diet
Treatment groups
Trial outcomes
Primary outcomes
Impact of Low-GI Functional Carbohydrates on TyG Index
To test whether functional low-glycemic index carbohydrates is able to reduce the Triglycerides-Glucose Index plasma levels versus standard wholegrain carbohydrates in healthy subjects
Secondary outcomes
Impact of Low-GI Functional Carbohydrates on Triglycerides
To test whether functional low-glycemic index carbohydrates is able to reduce the triglycerides plasma levels versus standard wholegrain carbohydrates in healthy subjects with suboptimal triglycerides levels
Impact of Low-GI Functional Carbohydrates on Fasting Glucose
To test whether functional low-glycemic index carbohydrates is able to reduce the fasting glucose plasma levels versus standard wholegrain carbohydrates in healthy subjects with suboptimal triglycerides levels
Impact of Low-GI Functional Carbohydrates on Non-HDL Cholesterol
To test whether functional low-glycemic index carbohydrates is able to reduce the Non-HDL cholesterol plasma levels versus standard wholegrain carbohydrates in healthy subjects with suboptimal triglycerides levels.
Impact of Low-GI Functional Carbohydrates on Apolipoprotein B
To test whether functional low-glycemic index carbohydrates is able to reduce the apolipoprotein B plasma levels versus standard wholegrain carbohydrates in healthy subjects with suboptimal triglycerides levels
Sponsors and contacts
Click on the lead sponsor to view all of their trials.