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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: Enriched panettone; Other: Panettone standard

• Registration Number: NCT06032260
• Lead Sponsor: University of Turin, Italy

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.

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 Timeline

• Study Start: 2023-01-20
• Primary Completion: 2023-06-30
• Study Completion: 2023-07-30
• Study First Submitted: 2023-08-31
• Status Verified: 2023-09
• Study First Submitted QC: 2023-09-08
• Study First Posted: 2023-09-11
• Last Update Submitted: 2023-09-11
• Last Update Posted: 2023-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Enriched panettone	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
Panettone standard	Panettone standard	100 grams of panettone without fiber enrichment

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Turin; 🇮🇹 Turin, AT, Italy