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

Sponsor

University of Turin, Italy (Other)

Overall Status

Completed

CT.gov ID

NCT06032260

Collaborator

(none)

Enrollment

Location

Arms

6.3

Actual Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Other: Enriched panettone Other: Panettone standard	N/A

Detailed Description

This is a crossover, randomized double-blind trial. A product enriched with arabinoxylan extracted from threshing (panettone, p-rich, a sweet baked product with a high glycemic index) was developed to assess the impact on metabolic responses and satiety when compared to the standard product (p-standard) .

Ten Caucasian non-smoker healthy adult volunteers were enrolled starting from January 2023.

Participants were randomized to receive either the p-rich or p-standard. The order of administration of each product was randomized using a computer-generated sequence. The day of each test, fasting individuals underwent a blood sample collection, and weight and height measurements. Then, participants consumed 100 grams of the product within 20 minutes, while sitting. Blood samples were collected at 15, 30, 45, 60, 90, 120 minutes after the consumption of each food.

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

crossover randomized double-blind trialcrossover randomized double-blind trial

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Prevention

Official Title:

The Effects of a Fiber-enriched Bakery Product on Glucose, Insulin Values and Appetite. A Pilot Randomized Cross-over Trial

Actual Study Start Date :

Jan 20, 2023

Actual Primary Completion Date :

Jun 30, 2023

Actual Study Completion Date :

Jul 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Enriched panettone 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 Volunteers consumed 100 grams of panettone enriched with fiber (JAX Plus® (Heallo srl, Milano, Italy), a soluble fiber with Arabinoxylans from wheat and barley
Active Comparator: Panettone standard 100 grams of panettone without fiber enrichment	Other: Panettone standard Volunteers consumed 100 grams of panettone standard

Arm

Intervention/Treatment

Experimental: Enriched panettone

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

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

Active Comparator: Panettone standard

100 grams of panettone without fiber enrichment

Other: Panettone standard

Volunteers consumed 100 grams of panettone standard

Outcome Measures

Primary Outcome Measures

Changes in circulating concentrations of glucose [15, 30, 45, 60, 90, 120 minutes after the consumption of each food]
To evaluate changes in glucose responses after the consumption of p-rich when compared to p-standard

Secondary Outcome Measures

Changes in circulating concentrations of insulin [15, 30, 45, 60, 90, 120 minutes after the consumption of each food]
To evaluate changes in insulin responses after the consumption of p-rich when compared to p-standard
Changes in subjective appetite score (VAS) [60, 120, 180, and 240 minutes after the consumption of each food]
To evaluate changes in appetite responses after the consumption of p-rich when compared to p-standard. Subjective sensations of appetite were assessed by a visual analogue scale (VAS) ranging from 0 to 10.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Turin	Turin	AT	Italy	10126

Sponsors and Collaborators

University of Turin, Italy

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Simona Bo, Associate Professor, University of Turin, Italy

ClinicalTrials.gov Identifier:

NCT06032260

Other Study ID Numbers:

PAN_2023

First Posted:

Sep 11, 2023

Last Update Posted:

Sep 13, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Simona Bo, Associate Professor, University of Turin, Italy

Arabinoxylan

fiber-enriched product

glycemia

insulin

appetite

Study Results

No Results Posted as of Sep 13, 2023