Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
35 participants
INTERVENTIONAL
2021-09-22
2025-12-31
Brief Summary
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Secondary objectives are:
Changes in immune parameters during the LCD period; Differences in fecal microbiome during the LCD period; Differences in fecal, serum and urine metabolome during the LCD period;
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Low-carbohydrate diet
The subjects will be delivered five pre-made ready meals per day throughout the period (5 weeks). These will contain age- and gender-specific recommended amount of calories but the amount of carbohydrates would be limited to provide only 15% (+/- 5%) of the recommended energy a day.
Low-carbohydrate diet
The diet will contain age- and gender-specific recommended amount of calories but the amount of carbohydrates would be limited to provide only 15% (+/- 5%) of the recommended energy a day.
Recommended carbohydrate diet
The subjects will be delivered five pre-made ready meals per day throughout the period (5 weeks). These will contain age- and gender-specific recommended amount of calories with 50% (+/- 5%) of the recommended energy from carbohydrates.
Recommended-carbohydrate diet
The subjects will be delivered five pre-made ready meals per day throughout the period (5 weeks). These will contain age- and gender-specific recommended amount of calories with the amount of carbohydrates equal to 45% (+/- 5%) of the recommended energy a day.
Interventions
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Low-carbohydrate diet
The diet will contain age- and gender-specific recommended amount of calories but the amount of carbohydrates would be limited to provide only 15% (+/- 5%) of the recommended energy a day.
Recommended-carbohydrate diet
The subjects will be delivered five pre-made ready meals per day throughout the period (5 weeks). These will contain age- and gender-specific recommended amount of calories with the amount of carbohydrates equal to 45% (+/- 5%) of the recommended energy a day.
Eligibility Criteria
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Inclusion Criteria
* T1D duration for at least 1 year prior to the intervention
* continuous glucose monitor (CGM) worn \> 70% time in the month prior to the intervention
Exclusion Criteria
* subject has celiac disease
* daily average carbohydrate intake \< 130 g/day from 14 days food record prior to the intervention
* any concomitant disease possibly affecting glucose control
* any chronic medication possibly affecting glucose control
6 Years
20 Years
ALL
No
Sponsors
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Czech Academy of Sciences
OTHER
University Hospital, Motol
OTHER
Responsible Party
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Zdeněk Šumník
Prof.
Locations
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University Hospital Motol
Prague, Prague, Czechia
Countries
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Other Identifiers
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NU21-01-00085
Identifier Type: -
Identifier Source: org_study_id