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Completed

NCT Number: NCT07682857

Effects of an Arabinoxylan-enriched Rusk on Postprandial Glucose, Insulin, Glucagon-like Peptide-1 and Appetite Responses

The aim of the present pilot randomized controlled trial is to compare the effects of the following: 1)-rusk enriched with arabinoxylans (r-rich), 2)-rusk not enriched (r-standard) on blood glucose, insulin values, glucagon like peptide (GLP-1) and appetite scores in 10 healthy volunteers.

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Key information

Conditions

Healthy Adult Participants 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

Torino, Italy, 10126

About this study

This is a double-blind, randomized crossover trial. A rusk product enriched with arabinoxylan extracted from threshing residues, hereafter referred to as r-rich, was developed to evaluate its effects on postprandial metabolic responses and satiety compared with the standard product, referred to as r-standard. Ten healthy adult Caucasian non-smoker volunteers were enrolled starting from October 2025. Participants received both products in a computer-generated randomized sequence, with a washout period of at least 72 hours between test sessions. On each test day, after an overnight fast, participants underwent baseline blood sample collection and anthropometric measurements, including body weight and height. They then consumed 100 g of the assigned product within 20 minutes while seated. Blood samples were collected at 20, 60, 90, 120 and 180 minutes after product consumption.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • healthy adults;
  • age 20-65 years;
  • ability to provide informed written consent.

Exclusion criteria

  • obesity;
  • acute or chronic diseases;
  • pharmacological therapies or supplements potentially influencing glycemic and/or insulinemic responses;
  • dietary restrictions;
  • allergy or intolerance to the tested food

Treatment and study plan

Enriched rusk

Other

Volunteers consumed 100 grams of rusk enriched with fiber (JAX Plus® (Heallo srl, Milano, Italy), a soluble fiber with Arabinoxylans from wheat and barley

Standard rusk

Other

Volunteers consumed 100 grams of standard rusk

Primary outcomes

  1. Change in circulating blood glucose concentration (metabolic variables) [mg/dL]

    Time frame: 20, 60, 90, 120, and 180 minutes after the consumption of each food.

    Evaluation of changes in glucose responses after the consumption of r-rich when compared to r-standard. The unit of measure for glucose concentration is milligrams per deciliter (mg/dL).

  2. Change in circulating serum insulin levels (metabolic variables) [mIU/ml]

    Time frame: 20, 60, 90, 120 and 180 minutes after the consumption of each food.

    Evaluation of changes in insulin responses after the consumption of r-rich when compared to r-standard. The unit of measure for insulin is milli-international units per milliliter (mIU/ml).

  3. Change in circulating glucagon-like peptide-1 (GLP-1) concentration [pg/ml]

    Time frame: 20, 60, 90, 120 and 180 minutes after consumption of each food.

    Evaluation of changes in GLP-1 responses after the consumption of r-rich when compared to r-standard. The unit of measure for GLP-1 is picograms per milliliter (pg/mL).

Secondary outcomes

  1. Postprandial Subjective Satiety Perception

    Time frame: 60, 120, 180, and 240 minutes post-consumption.

    Satiety perception was assessed using the Visual Analogue Scale (VAS; 0-100 mm), where 0 = "not satiated at all" and 100 = "extremely satiated". Higher scores indicate greater satiety.

  2. Postprandial Hunger

    Time frame: 60, 120, 180, and 240 minutes post-consumption.

    Hunger perception was assessed using the Visual Analogue Scale (VAS; 0-100 mm), where 0 = "not hungry at all" and 100 = "extremely hungry". Higher scores indicate greater hunger.

  3. Postprandial Gastric Fullness

    Time frame: 60, 120, 180, and 240 minutes post-consumption.

    Gastric fullness perception was assessed using the Visual Analogue Scale (VAS; 0-100 mm), where 0 = "not full at all" and 100 = "extremely full". Higher scores indicate greater fullness.

  4. Prospective Food Consumption

    Time frame: 60, 120, 180, and 240 minutes post-consumption.

    Prospective food consumption was assessed using the Visual Analogue Scale (VAS; 0-100 mm), where 0 = "no desire to eat at all" and 100 = "extreme desire to eat". Higher scores indicate greater desire for food intake.

  5. Gastrointestinal Symptoms Evaluation

    Time frame: Within 24 hours after rusk intake.

    Self-reported evaluation of gastrointestinal symptoms potentially related to snack consumption, assessed using the Gastrointestinal Symptom Rating Scale (GSRS). The GSRS uses a 10-point Likert scale (1 = no symptoms, 10 = very severe symptoms). Higher scores indicate more severe gastrointestinal symptoms.

Sponsors and collaborators

Lead sponsor

University of Turin, Italy

Other

Registry information

Official study title

Effects of an Arabinoxylan-enriched Rusk on Postprandial Glucose, Insulin, Glucagon-like Peptide-1 and Appetite Responses: a Pilot Randomized Cross-over Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jul 6, 2026
Registry last updated
Jul 6, 2026

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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