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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enriched panettone | Experimental | 100 grams of panettone enriched with fiber. The added fiber is JAX Plus® (Heallo srl, Milano, Italy), a soluble fiber with Arabinoxylans from wheat and barley |
|
| Panettone standard | Active Comparator | 100 grams of panettone without fiber enrichment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enriched panettone | Other | Volunteers consumed 100 grams of panettone enriched with fiber (JAX Plus® (Heallo srl, Milano, Italy), a soluble fiber with Arabinoxylans from wheat and barley |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in circulating concentrations of glucose | To evaluate changes in glucose responses after the consumption of p-rich when compared to p-standard | 15, 30, 45, 60, 90, 120 minutes after the consumption of each food |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in circulating concentrations of insulin | To evaluate changes in insulin responses after the consumption of p-rich when compared to p-standard | 15, 30, 45, 60, 90, 120 minutes after the consumption of each food |
| Changes in subjective appetite score (VAS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Turin | Turin | AT | 10126 | Italy |
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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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crossover randomized double-blind trial
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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.
| Panettone standard | Other | Volunteers consumed 100 grams of panettone standard |
|
To 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. |
| 60, 120, 180, and 240 minutes after the consumption of each food |