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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06032260
• Other study ID #: PAN_2023
• Status: Completed
• Phase: N/A
• Start date: January 20, 2023
• Est. completion date: July 30, 2023

Study information

• Verified date: September 2023
• Source: University of Turin, Italy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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
• Panettone standard
Volunteers consumed 100 grams of panettone standard

Locations

Country	Name	City	State
Italy	University of Turin	Turin	AT

Sponsors (1)

Lead Sponsor	Collaborator
University of Turin, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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