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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Bologna

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Altograno® Bakery Foods

    Other intervention

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

  • Standard Whole-Grain Bakery Foods

    Other intervention

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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Altograno® Bakery FoodsActive comparator 1 intervention
Group B: Standard Whole-Grain Bakery FoodsPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
28 days

Secondary outcomes

1

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

Time frame
28 days
2

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

Time frame
28 days
3

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.

Time frame
28 days
4

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

Time frame
28 days

Other outcomes

Sponsors and contacts

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