NCT07682857

Brief Summary

The aim of the present pilot randomized controlled trial is to compare the effects of the following: 1)-rusk enriched with arabinoxylans (r-rich), 2)-rusk not enriched (r-standard) on blood glucose, insulin values, glucagon like peptide (GLP-1) and appetite scores in 10 healthy volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

January 10, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 6, 2026

Completed
Last Updated

July 6, 2026

Status Verified

June 1, 2026

Enrollment Period

11 months

First QC Date

June 23, 2026

Last Update Submit

June 30, 2026

Conditions

Healthy Adult Participants

Keywords

Arabinoxylanfiber-enriched productinsulinGLP-1appetiteglycemia

Outcome Measures

Primary Outcomes (3)

  • Change in circulating blood glucose concentration (metabolic variables) [mg/dL]

    Evaluation of changes in glucose responses after the consumption of r-rich when compared to r-standard. The unit of measure for glucose concentration is milligrams per deciliter (mg/dL).

    20, 60, 90, 120, and 180 minutes after the consumption of each food.

  • Change in circulating serum insulin levels (metabolic variables) [mIU/ml]

    Evaluation of changes in insulin responses after the consumption of r-rich when compared to r-standard. The unit of measure for insulin is milli-international units per milliliter (mIU/ml).

    20, 60, 90, 120 and 180 minutes after the consumption of each food.

  • Change in circulating glucagon-like peptide-1 (GLP-1) concentration [pg/ml]

    Evaluation of changes in GLP-1 responses after the consumption of r-rich when compared to r-standard. The unit of measure for GLP-1 is picograms per milliliter (pg/mL).

    20, 60, 90, 120 and 180 minutes after consumption of each food.

Secondary Outcomes (5)

  • Postprandial Subjective Satiety Perception

    60, 120, 180, and 240 minutes post-consumption.

  • Postprandial Hunger

    60, 120, 180, and 240 minutes post-consumption.

  • Postprandial Gastric Fullness

    60, 120, 180, and 240 minutes post-consumption.

  • Prospective Food Consumption

    60, 120, 180, and 240 minutes post-consumption.

  • Gastrointestinal Symptoms Evaluation

    Within 24 hours after rusk intake.

Study Arms (2)

Enriched rusk

EXPERIMENTAL

100 grams of rusk enriched with fiber. The added fiber is JAX Plus® (Heallo srl, Milano, Italy), a soluble fiber with Arabinoxylans from wheat and barley

Other: Enriched rusk

Standard rusk

ACTIVE COMPARATOR

100 grams of panettone without fiber enrichment

Other: Standard rusk

Interventions

Enriched ruskOTHER

Volunteers consumed 100 grams of rusk enriched with fiber (JAX Plus® (Heallo srl, Milano, Italy), a soluble fiber with Arabinoxylans from wheat and barley

Enriched rusk
Standard ruskOTHER

Volunteers consumed 100 grams of standard rusk

Standard rusk

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy adults;
  • age 20-65 years;
  • ability to provide informed written consent.

You may not qualify if:

  • obesity;
  • acute or chronic diseases;
  • pharmacological therapies or supplements potentially influencing glycemic and/or insulinemic responses;
  • dietary restrictions;
  • allergy or intolerance to the tested food

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Turin

Torino, Italy, 10126, Italy

Location

Related Publications (1)

  • Ponzo V, Ojeda-Mercado D, Finocchiaro C, Goitre I, Favaro E, Lamberti L, Bo S. The effects of a fibre-enriched bakery product on glucose, insulin values and appetite. A pilot randomised cross-over trial. Int J Food Sci Nutr. 2024 Jun;75(4):407-415. doi: 10.1080/09637486.2024.2314679. Epub 2024 Feb 14.

    PMID: 38356166BACKGROUND

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Neither the participant nor the investigators were aware of the composition of the administered food. The two types of foods were identical for packages, color, flavor, smell, and appearance. Furthermore, the researchers who analyzed data and the laboratory personnel who performed the biochemical analyses were blinded to the group assigned.
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 23, 2026

First Posted

July 6, 2026

Study Start

January 10, 2025

Primary Completion

November 30, 2025

Study Completion

April 30, 2026

Last Updated

July 6, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)