Healthy Adult Participants
Conditions
Keywords
Arabinoxylan, fiber-enriched product, insulin, GLP-1, appetite, glycemia
Brief summary
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.
Detailed description
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.
Interventions
OTHEREnriched rusk
Volunteers consumed 100 grams of rusk enriched with fiber (JAX Plus® (Heallo srl, Milano, Italy), a soluble fiber with Arabinoxylans from wheat and barley
OTHERStandard rusk
Volunteers consumed 100 grams of standard rusk
Sponsors
University of Turin, Italy
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in circulating blood glucose concentration (metabolic variables) [mg/dL] | 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). |
| Change in circulating serum insulin levels (metabolic variables) [mIU/ml] | 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). |
| Change in circulating glucagon-like peptide-1 (GLP-1) concentration [pg/ml] | 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
| Measure | Time frame | Description |
|---|---|---|
| Postprandial Subjective Satiety Perception | 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. |
| Postprandial Hunger | 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. |
| Postprandial Gastric Fullness | 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. |
| Prospective Food Consumption | 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. |
| Gastrointestinal Symptoms Evaluation | 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. |
Countries
Italy
Outcome results
None listed