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Cardiovascular PreventionGLOWNCT07198789

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

A study testing Altograno® Bakery Foods and Standard Whole-Grain Bakery Foods in people with Cardiovascular Prevention and Diabetes Prevention, run by University of Bologna at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Altograno® Bakery Foods and Standard Whole-Grain Bakery Foods
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteItaly
Study dates
2 Feb 2026to 29 Sep 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Italy1 site, 1 recruiting
  • Cardiovascular Internal Medicine Unit, IRCCS University Hospital of Bologna, Bologna, Italy

    Bologna, BO, 40100

    Arrigo Francesco Giuseppe Cicero, MD, PhD, +39 051 2142224, arrigo.cicero@unibo.it

    Recruiting

Other trials in Italy

About this study

Official title: 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

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.

Read the 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.

In children and adolescents, low-GI intake improves insulin sensitivity and reduces early markers of vascular damage. A randomized controlled trial demonstrated that adolescents on a low-GI diet exhibited lower carotid intima-media thickness (IMT), a surrogate marker of atherosclerosis progression, after six months.

Furthermore, a Mediterranean dietary pattern, which is naturally low in GI due to its emphasis on legumes, whole grains, and vegetables, has been linked to a 30% reduction in major cardiovascular events in high-risk populations. The PREDIMED trial showed that such a diet significantly reduced the incidence of myocardial infarction and stroke over five years.

Inflammation plays a central role in both T2DM and CVD, and low-GI diets help reduce C-reactive protein (CRP) levels by 0.5-1.0 mg/L on average. This anti-inflammatory effect may be one of the mechanisms through which low-GI diets offer cardiovascular protection.

Even among elderly individuals, adherence to low-GI diets has been associated with better cognitive function and glycemic control. A cross-sectional analysis showed that older adults in the highest tertile of dietary GI had significantly lower memory scores than those in the lowest tertile.

The combined effects of low-GI diets-improving glucose control, reducing inflammation, enhancing lipid profiles, and promoting satiety-make them an essential component of preventive nutrition strategies for chronic disease.

Public health guidelines increasingly recommend the substitution of refined carbohydrates with low-GI alternatives to curb the global diabetes epidemic. However, no direct comparison has been made so far between functional low-glycemic index carbohydrates and standard wholegrain carbohydrates in the context of a Mediterranean diet.

In this context, the primary purpose of our research will be to evaluate if functional low-glycemic index carbohydrates are able to reduce the Triglycerides-Glucose Index plasma levels versus standard wholegrain carbohydrates in healthy subjects with suboptimal triglycerides levels. The Triglycerides-Glucose Index is a cheap, validated, emerging risk factors for both metabolic and cardiovascular diseases.

Being tested
Altograno® Bakery Foods, Standard Whole-Grain Bakery Foods
Keywords
Low glycemic index, Low-GI diet, Triglycerides-Glucose Index, Low-glycemic index carbohydrates, Wholegrain carbohydrates, Altograno®
Medical subject headings
Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Altograno® Bakery FoodsOther

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

  • Standard Whole-Grain Bakery FoodsOther

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

Study groups in NCT07198789
Study groupRoleWhat they receive
Altograno® Bakery FoodsActive comparatorAltograno® Pasta, Pizza and Flatbrad
Receives: Other: Altograno® Bakery Foods
Standard Whole-Grain Bakery FoodsPlacebo comparatorIndustrial standard whole-grain Pasta, Pizza and Flatbrad, in substitution of the same amount of carbohydrates usually eaten in a stabilized diet
Receives: Other: Standard Whole-Grain Bakery Foods

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 28 days

Secondary outcomes (6)
  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

    Measured: 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

    Measured: 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.

    Measured: 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

    Measured: 28 days

  5. Impact of Low-GI Functional Carbohydrates on hsCRP

    To test whether functional low-glycemic index carbohydrates is able to reduce the hsCRP plasma levels versus standard wholegrain carbohydrates in healthy subjects with suboptimal triglycerides levels.

    Measured: 28 days

  6. Impact of Low-GI Functional Carbohydrates on Endothelial Function

    To test whether functional low-glycemic index carbohydrates is able to improve the endothelial function standard wholegrain carbohydrates in healthy subjects with suboptimal triglycerides levels.

    Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2025
  2. Study start2 Feb 2026
  3. Primary completion29 Sep 2026 (estimated)
  4. Study completion29 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07198789
Sponsor's protocol ID
PNRR_ONFOODS_LowCharb
Acronym
GLOW
Status last verified
Apr 2026
First submitted
21 Sep 2025
Last updated
1 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Giovannini M, Fogacci F, Scollo C, Micoli VD, Grandi E, Cicero AFG; GLOW Study Group. Randomized, Double-Blind, Crossover Trial Comparing Low-Glycemic Index Functional and Conventional Wholegrain Carbohydrates on Glycolipid Metabolism and Vascular Stress Markers in Adults with Suboptimal Triglyceridemia: The GLOW Study. J Clin Med. 2026 Feb 25;15(5):1745. doi: 10.3390/jcm15051745.

    PubMed 41827162

Questions about this trial

What is this clinical trial studying?

A study testing Altograno® Bakery Foods and Standard Whole-Grain Bakery Foods in people with Cardiovascular Prevention and Diabetes Prevention, run by University of Bologna at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Impact of Low-GI Functional Carbohydrates on TyG Index (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07198789, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.

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