NCT07198789

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress40%
Feb 2026Sep 2026

First Submitted

Initial submission to the registry

September 21, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 30, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

February 2, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2026

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

8 months

First QC Date

September 21, 2025

Last Update Submit

April 27, 2026

Conditions

Cardiovascular PreventionInflammationNutritionDiabetes Prevention

Keywords

Low glycemic indexLow-GI dietTriglycerides-Glucose IndexLow-glycemic index carbohydratesWholegrain carbohydratesAltograno®

Outcome Measures

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

    28 days

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

Altograno® Bakery Foods

ACTIVE COMPARATOR

Altograno® Pasta, Pizza and Flatbrad

Other: Altograno® Bakery Foods

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

Other: Standard Whole-Grain Bakery Foods

Interventions

Altograno® Bakery FoodsOTHER

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

Altograno® Bakery Foods
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

Standard Whole-Grain Bakery Foods

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Bologna, BO, 40100, Italy

RECRUITING

Related Publications (1)

  • 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.

    PMID: 41827162DERIVED

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

September 21, 2025

First Posted

September 30, 2025

Study Start

February 2, 2026

Primary Completion (Estimated)

September 29, 2026

Study Completion (Estimated)

September 29, 2026

Last Updated

May 1, 2026

Record last verified: 2026-04

Locations

IT(1)