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Completed

NCT Number: NCT06032260

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

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.

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Key information

Conditions

Healthy Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Turin

Turin, AT, 10126, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enriched panettone

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

Other

Volunteers consumed 100 grams of panettone standard

Primary outcomes

  1. Changes in circulating concentrations of glucose

    Time frame: 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 outcomes

  1. Changes in circulating concentrations of insulin

    Time frame: 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

  2. Changes in subjective appetite score (VAS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Turin, Italy

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 11, 2023
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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