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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Enriched panettone; Other: Panettone standard

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • AT
    • Turin, AT, Italy, 10126
      • University of Turin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in circulating concentrations of insulin	To evaluate changes in insulin 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
Changes in subjective appetite score (VAS)	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.	60, 120, 180, and 240 minutes after the consumption of each food

Collaborators and Investigators

• Sponsor: University of Turin, Italy

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2023
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): July 30, 2023

Study Registration Dates

• First Submitted: August 31, 2023
• First Submitted That Met QC Criteria: September 8, 2023
• First Posted (Actual): September 11, 2023

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: appetite; insulin; glycemia; Arabinoxylan; fiber-enriched product
• Other Study ID Numbers: PAN_2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No