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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06032260
Enrollment
10
Registered
2023-09-11
Start date
2023-01-20
Completion date
2023-07-30
Last updated
2023-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Arabinoxylan, fiber-enriched product, glycemia, insulin, appetite

Brief summary

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.

Detailed description

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.

Interventions

OTHEREnriched panettone

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

OTHERPanettone standard

Volunteers consumed 100 grams of panettone standard

Sponsors

University of Turin, Italy
Lead SponsorOTHER

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.

Intervention model description

crossover randomized double-blind trial

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in circulating concentrations of glucose15, 30, 45, 60, 90, 120 minutes after the consumption of each foodTo evaluate changes in glucose responses after the consumption of p-rich when compared to p-standard

Secondary

MeasureTime frameDescription
Changes in circulating concentrations of insulin15, 30, 45, 60, 90, 120 minutes after the consumption of each foodTo evaluate changes in insulin responses after the consumption of p-rich when compared to p-standard
Changes in subjective appetite score (VAS)60, 120, 180, and 240 minutes after the consumption of each foodTo 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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026