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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Other: Enriched panettone
* Other: Panettone standard


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: crossover randomized double-blind trial
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arabinoxylan, fiber-enriched product, glycemia, insulin, appetite