Healthy Adult ParticipantsNCT07682857
Effects of an Arabinoxylan-enriched Rusk on Postprandial Glucose, Insulin, Glucagon-like Peptide-1 and Appetite Responses
A study testing Enriched rusk and Standard rusk in people with Healthy Adult Participants, run by University of Turin, Italy at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Participants
- What is being tested?
- Enriched rusk and Standard rusk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- 10 Jan 2025to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy adults;
- age 20-65 years;
- ability to provide informed written consent.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of an Arabinoxylan-enriched Rusk on Postprandial Glucose, Insulin, Glucagon-like Peptide-1 and Appetite Responses: a Pilot Randomized Cross-over Trial
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.
Read the 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.
- Conditions
- Healthy Adult Participants
- Being tested
- Enriched rusk, Standard rusk
- Keywords
- Arabinoxylan, fiber-enriched product, insulin, GLP-1, appetite, glycemia
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enriched ruskOther
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 ruskOther
Volunteers consumed 100 grams of standard rusk
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Enriched rusk |
| Standard rusk | Active comparator | 100 grams of panettone without fiber enrichment Receives: Other: Standard rusk |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 20, 60, 90, 120 and 180 minutes after consumption of each food.
Secondary outcomes (5)
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.
Measured: 60, 120, 180, and 240 minutes post-consumption.
Postprandial Hunger
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within 24 hours after rusk intake.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start10 Jan 2025
- Primary completion30 Nov 2025
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy Adult ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simona Bo, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07682857
- Sponsor's protocol ID
- RUSK_FIBER_25
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38356166
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Arabinoxylan-enriched Rusk on Postprandial Glucose, Insulin, Glucagon-like Peptide-1 and Appetite Responses: a Pilot Randomized Cross-over Trial
- ClinicalTrials.gov ID
- NCT07682857
- Acronym / sponsor ID
- RUSK_FIBER_25
- Conditions
- Healthy Adult Participants
- Keywords
- Arabinoxylan, fiber-enriched product, insulin, GLP-1, appetite, glycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enriched rusk | Experimental | Other: Enriched rusk100 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 |
| Standard rusk | Active comparator | Other: Standard rusk100 grams of panettone without fiber enrichment |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- healthy adults;
- age 20-65 years;
- ability to provide informed written consent.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enriched ruskVolunteers consumed 100 grams of rusk enriched with fiber (JAX Plus® (Heallo srl, Milano, Italy), a soluble fiber with Arabinoxylans from wheat and barley | Other | Enriched rusk |
| Standard ruskVolunteers consumed 100 grams of standard rusk | Other | Standard rusk |
Primary outcome
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).
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).
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).
5 secondary outcomes
Postprandial Subjective Satiety Perception
Time frame: 60, 120, 180, and 240 minutes post-consumption.
Postprandial Hunger
Time frame: 60, 120, 180, and 240 minutes post-consumption.
Postprandial Gastric Fullness
Time frame: 60, 120, 180, and 240 minutes post-consumption.
Prospective Food Consumption
Time frame: 60, 120, 180, and 240 minutes post-consumption.
Gastrointestinal Symptoms Evaluation
Time frame: Within 24 hours after rusk intake.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Background: PubMed 38356166Ponzo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enriched rusk and Standard rusk in people with Healthy Adult Participants, run by University of Turin, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07682857, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.