The Effects of a Fiber-enriched Bakery Product on Glucose, Insulin Values and Appetite

NCT06032260 | Completed

• 1 other identifier: PAN_2023
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Arabinoxylan; fiber-enriched product; glycemia; insulin; appetite

Outcome Measures

Primary Outcomes (1)

• Changes in circulating concentrations of glucose

  To evaluate changes in glucose responses after the consumption of p-rich when compared to p-standard

  15, 30, 45, 60, 90, 120 minutes after the consumption of each food

Secondary Outcomes (2)

• Changes in circulating concentrations of insulin

  15, 30, 45, 60, 90, 120 minutes after the consumption of each food

• Changes in subjective appetite score (VAS)

  60, 120, 180, and 240 minutes after the consumption of each food

Study Arms (2)

Enriched panettone

EXPERIMENTAL

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

Other: Enriched panettone

Panettone standard

ACTIVE COMPARATOR

100 grams of panettone without fiber enrichment

Other: Panettone standard

Interventions

Enriched panettone OTHER

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

Enriched panettone

Panettone standard OTHER

Volunteers consumed 100 grams of panettone standard

Panettone standard

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• obesity;
• chronic diseases or pharmacological therapies;
• dietary restrictions;
• allergy or intolerance to the tested food

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (1)

University of Turin

Turin, AT, 10126, Italy

Location

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional 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

Model Details: crossover randomized double-blind trial

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: September 11, 2023
• Study Start: January 20, 2023
• Primary Completion: June 30, 2023
• Study Completion: July 30, 2023
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)