NCT03380988

Fiber-enriched Buckwheat Pasta and Glucose Variability in Patients With Type 1 Diabetes and Celiac Disease

Fiber-enriched Buckwheat Pasta Reduces Daily Glucose Variability in Patients With Type 1 Diabetes and Celiac Disease: an Acute Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Federico II University · Academic / Other
• Sex: All
• Age: 20 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The intervention was preceded by a 1-week run-in period during which participants underwent continuous glucose monitoring (CGM) and filled in a 7-day dietary record to optimize basal infusion rate and insulin-to-glycemic load ratio. The study had a randomized crossover design with each subject studied on 2 occasions at least 1 week apart. Participants were assigned to consume, in random order, two test meals with the same amount of carbohydrates (50g): a meal containing fiber-enriched buckwheat pasta (FBP) or corn pasta (CP), used as control. Over the experimental period, participants underwent CGM, wearing their sensors 7 days/week.

Conditions

• Type 2 Diabetes Mellitus
• Celiac Disease

Interventions

Type	Name	Description
OTHER	Acute test meal with fiber-enriched buckwheat pasta	Pasta with tomato sauce (100g tomato sauce, 5g extra-virgin olive oil)
OTHER	Acute test meal with corn pasta	Pasta with tomato sauce (100g tomato sauce, 5g extra-virgin olive oil)

Timeline

• Start date: 2015-11-01
• Primary completion: 2016-12-01
• Completion: 2017-02-01
• First posted: 2017-12-21
• Last updated: 2017-12-21

Locations

1 site across 1 country: Italy