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

NCT ID: NCT06032260

Last Updated: 2023-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-20
• Study Completion Date: 2023-07-30

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: EXPERIMENTAL

Enriched panettone

Intervention Type: 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

Panettone standard

100 grams of panettone without fiber enrichment

Group Type: ACTIVE_COMPARATOR

Panettone standard

Intervention Type: OTHER

Volunteers consumed 100 grams of panettone standard

Interventions

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

Intervention Type: OTHER

Panettone standard

Volunteers consumed 100 grams of panettone standard

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Turin, Italy

OTHER

Sponsor Role: lead

Responsible Party

Simona Bo

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Turin

Turin, AT, Italy

Countries

Italy

Other Identifiers

PAN_2023

Identifier Type: -

Identifier Source: org_study_id