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Clinical Trials/NCT07198789
NCT07198789RecruitingNot Applicable

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

University of Bologna1 site in 1 country40 target enrollmentStarted: February 2, 2026Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
40
Locations
1
Primary Endpoint
Impact of Low-GI Functional Carbohydrates on TyG Index

Study Overview

Brief 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.

Detailed Description

The consumption of carbohydrates with a low glycemic index (GI) has emerged as a cornerstone in the dietary prevention of type 2 diabetes mellitus (T2DM) and cardiovascular disease (CVD). The glycemic index classifies carbohydrate-containing foods based on their impact on postprandial blood glucose: low-GI foods have a GI ≤ 55, medium-GI between 56 and 69, and high-GI ≥ 70. Low-GI foods cause slower and smaller rises in blood glucose and insulin, which can reduce glycemic variability and postprandial hyperglycemia.

Postprandial hyperglycemia is known to trigger oxidative stress and endothelial dysfunction, mechanisms closely involved in the pathogenesis of atherosclerosis and diabetic vascular complications. Clinical trials show that replacing high-GI carbohydrates with low-GI options improves fasting blood glucose by an average of 0.4 mmol/L and HbA1c by 0.3% in individuals with impaired glucose tolerance. These modest changes translate into meaningful reductions in the long-term risk of diabetes.

A pooled analysis of 24 prospective cohort studies found that a high-GI diet was associated with a 27% greater risk of developing T2DM. Moreover, each 5-unit increment in dietary GI increases the risk of coronary heart disease (CHD) by 13%. The metabolic advantage of low-GI carbohydrates lies in their ability to limit insulin spikes, reduce inflammatory cytokine release, and lower triglyceride synthesis.

In overweight individuals, low-GI diets are associated with greater weight loss and fat mass reduction than high-GI diets, even when total calories are similar. One study found that participants on a low-GI diet lost 1.5 kg more fat mass over 12 weeks compared to those on a high-GI diet, despite identical energy intake.

Low-GI foods also improve lipid profiles. A systematic review and meta-analysis reported a mean reduction of 0.13 mmol/L in LDL cholesterol and a 0.05 mmol/L increase in HDL cholesterol among participants consuming low-GI diets. These effects are particularly relevant in patients with metabolic syndrome or insulin resistance.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Altograno® Bakery Foods

Active Comparator

Altograno® Pasta, Pizza and Flatbrad

Intervention: Altograno® Bakery Foods (Other)

Standard Whole-Grain Bakery Foods

Placebo Comparator

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

Intervention: Standard Whole-Grain Bakery Foods (Other)

Outcomes

Primary Outcomes

Impact of Low-GI Functional Carbohydrates on TyG Index

Time Frame: 28 days

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 Endothelial Function(28 days)
  • Impact of Low-GI Functional Carbohydrates on Triglycerides(28 days)
  • Impact of Low-GI Functional Carbohydrates on Fasting Glucose(28 days)
  • Impact of Low-GI Functional Carbohydrates on Non-HDL Cholesterol(28 days)
  • Impact of Low-GI Functional Carbohydrates on Apolipoprotein B(28 days)
  • Impact of Low-GI Functional Carbohydrates on hsCRP(28 days)

Investigators

Sponsor
University of Bologna
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Arrigo F.G. Cicero

MD, PhD

University of Bologna

Study Sites (1)

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