Clinical trial NCT05933460: Crocus Sativus Extract Impact in Metabolic Control of Patients With Diabetes Mellitus Type 1
Official title: Investigation of the Impact of the Administration of Crocus Sativus L Extract on the Metabolic Control of Patients With Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Diabetes type1
Keywords: diabetes mellitus type 1
diabetes type 1
saffron
saffron extract
continuous glucose monitoring
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2023-07-06
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blind placebo controlled randomized trial
Primary purpose: TREATMENT

Brief summary: Administration of 4 strain of probiotics, prebiotic, magnesium and crocus sativus extract in a sachet to people with diabetes mellitus type 1 for 6 months

Detailed description: Double blind placebo controlled randomized trial: A sachet of a combination of 4 strains of probiotics (Lactobacillus rhamnosus, Bifidobacterium animalis lactis, Bifidobacterium breve, Bifidobacterium longum), Fructooligosaccharides, Magnesium and Saffron extract was administered 3 times per day in people with diabetes type 1 for 6 months on continuous glucose monitoring systems.

Eligibility criteria: Inclusion Criteria:

* People with diabetes mellitus type 1 (with diabetes duration over 1 year) (adults \<18 years old) wearing a continuous glucose monitoring system with or without an insulin pump

Exclusion Criteria:

* Pregnant
* 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

Primary outcomes:
measure: glycated hemoglobin
timeFrame: 6 months
measure: blood glucose
timeFrame: 6 months
measure: serum cholesterol
timeFrame: 6 months
measure: serum High density lipoprotein cholesterol
timeFrame: 6 months
measure: serum low density lipoprotein cholesterol
timeFrame: 6 months
measure: triglycerides
timeFrame: 6 months
measure: Systolic Blood pressure
timeFrame: 6 months
measure: Diastolic Blood pressure
timeFrame: 6 months
Secondary outcomes:
measure: Continuous glucose monitoring data
timeFrame: 6 months
measure: Continuous glucose monitoring time
timeFrame: 6 months
measure: Continuous glucose monitoring time data
timeFrame: 6 months
measure: Continuous glucose monitoring glycemic data
timeFrame: 6 months
measure: Continuous glucose monitoring statistic data
timeFrame: 6 months
Other outcomes:
Locations:
city: Thessaloníki
country: Greece
facility: University General Hospital of Thessaloniki AHEPA
state: Central Macedonia
Study officials:
affiliation: Aristotle University Of Thessaloniki
name: Triantafyllos Didangelos, Professor
role: STUDY_DIRECTOR
References:
citation: 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.