Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07198789

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

Led by University of Bologna · Updated on 2026-05-01

40

Participants Needed

1

Research Sites

34 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female aged 18 years or older
  • Triglyceride levels greater than 150 mg/dL
  • Ability to communicate and follow study requirements
  • Willingness to participate and provide signed informed consent
Not Eligible

You will not qualify if you...

  • Diagnosis of gluten hypersensitivity or coeliac disease
  • Body mass index over 30 kg/m2
  • Unstable preventive treatments (lipid-lowering drugs, antihypertensives) within the last 3 months
  • Any medical or surgical condition limiting adherence to the study protocol

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

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

Bologna, BO, Italy, 40100

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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