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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enriched rusk | Experimental | 100 grams of rusk enriched with fiber. The added fiber is JAX Plus® (Heallo srl, Milano, Italy), a soluble fiber with Arabinoxylans from wheat and barley |
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| Standard rusk | Active Comparator | 100 grams of panettone without fiber enrichment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in circulating blood glucose concentration (metabolic variables) [mg/dL] | 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). | 20, 60, 90, 120, and 180 minutes after the consumption of each food. |
| Change in circulating serum insulin levels (metabolic variables) [mIU/ml] | 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). | 20, 60, 90, 120 and 180 minutes after the consumption of each food. |
| Change in circulating glucagon-like peptide-1 (GLP-1) concentration [pg/ml] | 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). | 20, 60, 90, 120 and 180 minutes after consumption of each food. |
| Measure | Description | Time Frame |
|---|---|---|
| Postprandial Subjective Satiety Perception | 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. | 60, 120, 180, and 240 minutes post-consumption. |
| Postprandial Hunger |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Turin | Torino | Italy | 10126 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38356166 | Background | Ponzo V, Ojeda-Mercado D, Finocchiaro C, Goitre I, Favaro E, Lamberti L, Bo S. The effects of a fibre-enriched bakery product on glucose, insulin values and appetite. A pilot randomised cross-over trial. Int J Food Sci Nutr. 2024 Jun;75(4):407-415. doi: 10.1080/09637486.2024.2314679. Epub 2024 Feb 14. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Oct 1, 2025 | Jun 30, 2026 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Neither the participant nor the investigators were aware of the composition of the administered food. The two types of foods were identical for packages, color, flavor, smell, and appearance. Furthermore, the researchers who analyzed data and the laboratory personnel who performed the biochemical analyses were blinded to the group assigned.
| Standard rusk | Other | Volunteers consumed 100 grams of standard rusk |
|
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. |
| 60, 120, 180, and 240 minutes post-consumption. |
| Postprandial Gastric Fullness | 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. | 60, 120, 180, and 240 minutes post-consumption. |
| Prospective Food 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. | 60, 120, 180, and 240 minutes post-consumption. |
| Gastrointestinal Symptoms Evaluation | 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. | Within 24 hours after rusk intake. |