Crocus Sativus Extract Impact in Metabolic Control of Patients With Diabetes Mellitus Type 1
NCT ID: NCT05933460
Last Updated: 2025-07-09
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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COMPLETED
NA
61 participants
INTERVENTIONAL
2022-03-01
2023-04-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Active Group
A sachet of a combination of 4 strains of probiotics (1billion CFU) (Lactobacillus rhamnosus, Bifidobacterium animalis lactis, Bifidobacterium breve, Bifidobacterium longum), Fructooligosaccharides 100mg, Magnesium 75mg and Crocus sativus (Saffron extract 28mg) was administered 3 times per day in people with diabetes type 1 for 6 months on continuous glucose monitoring systems.
dietary supplement with probiotics, prebiotics, magnesium and saffron extract
A sachet of a combination of 4 strains of probiotics (1billion CFU) (Lactobacillus rhamnosus, Bifidobacterium animalis subscp. lactis, Bifidobacterium breve, Bifidobacterium longum), Fructooligosaccharides 100mg, Magnesium 75mg and Saffron extract 28mg was administered 3 times per day
Placebo group
A sachet of a combination of 4 strains of probiotics (1billion CFU(Lactobacillus rhamnosus, Bifidobacterium animalis lactis, Bifidobacterium breve, Bifidobacterium longum), Fructooligosaccharides 100mg, Magnesium 75mg without crocus sativus was administered 3 times per day in people with diabetes type 1 for 6 months on continuous glucose monitoring systems.
dietary supplement with probiotics, prebiotics, magnesium
A sachet of a combination of 4 strains of probiotics (1billion CFU) (Lactobacillus rhamnosus, Bifidobacterium animalis subscp. lactis, Bifidobacterium breve, Bifidobacterium longum), Fructooligosaccharides 100mg, Magnesium 75mg was administered 3 times per day
Interventions
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dietary supplement with probiotics, prebiotics, magnesium and saffron extract
A sachet of a combination of 4 strains of probiotics (1billion CFU) (Lactobacillus rhamnosus, Bifidobacterium animalis subscp. lactis, Bifidobacterium breve, Bifidobacterium longum), Fructooligosaccharides 100mg, Magnesium 75mg and Saffron extract 28mg was administered 3 times per day
dietary supplement with probiotics, prebiotics, magnesium
A sachet of a combination of 4 strains of probiotics (1billion CFU) (Lactobacillus rhamnosus, Bifidobacterium animalis subscp. lactis, Bifidobacterium breve, Bifidobacterium longum), Fructooligosaccharides 100mg, Magnesium 75mg was administered 3 times per day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* People with diabetes mellitus type 2
* Breastfeeding women
* People with liver disease
* People with chronic kidney disease (over stage 3)
* People with allergy in crocus sativus
* People that consume everyday herbs or supplements
* People on anti platelet treatment not for prevention
18 Years
ALL
No
Sponsors
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Aristotle University Of Thessaloniki
OTHER
Responsible Party
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Prof. Triantafyllos Didangelos
Professor of Internal Medicine- Diabetology
Principal Investigators
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Triantafyllos Didangelos, Professor
Role: STUDY_DIRECTOR
Aristotle University Of Thessaloniki
Locations
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University General Hospital of Thessaloniki AHEPA
Thessaloniki, Central Macedonia, Greece
Countries
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References
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Giannoulaki P, Kotzakioulafi E, Chourdakis M, Hatzitolios A, Didangelos T. Impact of Crocus Sativus L. on Metabolic Profile in Patients with Diabetes Mellitus or Metabolic Syndrome: A Systematic Review. Nutrients. 2020 May 14;12(5):1424. doi: 10.3390/nu12051424.
Other Identifiers
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1.46-21/11/2018
Identifier Type: OTHER
Identifier Source: secondary_id
Diabetes1Crocus
Identifier Type: -
Identifier Source: org_study_id
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