Fiber-enriched Buckwheat Pasta and Glucose Variability in Patients With Type 1 Diabetes and Celiac Disease
NCT03380988 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2017-12-21
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
Interventions
- 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)
Sponsors & Collaborators
-
Federico II University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 20 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-11-30
- Primary Completion
- 2016-12-31
- Completion
- 2017-02-28
Countries
- Italy
Study Locations
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