Crocus Sativus Extract Impact in Metabolic Control of Patients With Diabetes Mellitus Type 1

NCT05933460 — Not applicable, Completed, 61 participants, Aristotle University Of Thessaloniki

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Investigation of the Impact of the Administration of Crocus Sativus L Extract on the Metabolic Control of Patients With Type 1 Diabetes Mellitus

Registry	NCT05933460
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	61 (Actual)
Sponsor	Aristotle University Of Thessaloniki (Other)
Conditions	Diabetes Mellitus, Type 1, Diabetes type1
Interventions	dietary supplement with probiotics, prebiotics, magnesium and saffron extract, dietary supplement with probiotics, prebiotics, magnesium (Dietary supplement)
Dates	start 2022-03-01, primary completion 2023-04-28, completion 2023-04-28, first posted 2023-07-06, last updated 2025-07-09
Locations	1 site in Greece

-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

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Active Group	Experimental	Dietary Supplement: 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 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.
Placebo group	Placebo comparator	Dietary Supplement: dietary supplement with probiotics, prebiotics, magnesium	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 and saffron extract (Dietary supplement), also known as Probiotics 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 (Dietary supplement), also known as Probiotics: 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

+Outcome measures

Primary outcomes

glycated hemoglobin [6 months]: glycated hemoglobin %
blood glucose [6 months]: Fasting blood glucose (mg/dl)
serum cholesterol [6 months]: Total Cholesterol mg/dl
serum High density lipoprotein cholesterol [6 months]: High density lipoprotein Cholesterol mg/dl
serum low density lipoprotein cholesterol [6 months]: Low density lipoprotein cholesterol mg/dl
triglycerides [6 months]: serum Triglycerides mg/dl
Systolic Blood pressure [6 months]: Systolic blood pressure mmHg
Diastolic Blood pressure [6 months]: Diastolic blood pressure mmHg

Secondary outcomes

Continuous glucose monitoring data [6 months]: Time in range %
Continuous glucose monitoring time [6 months]: Time below range %
Continuous glucose monitoring time data [6 months]: Time above range %
Continuous glucose monitoring glycemic data [6 months]: Glucose Management Indicator %
Continuous glucose monitoring statistic data [6 months]: Coefficient of variance
Sural nerve conduction velocity [6 months]: Nerve conduction velocity is measured in the sural sensory nerve of both feet with Neurometrix DPNCheck
Electrochemical skin conductance [6 months]: Sudomotor function was assessed with SUDOSCAN, which measures electrochemical skin conductance in the feet (ESCF) and hands (ESCH)
Cardiovascular Autonomic Reflex tests [6 months]: Autonomic neuropathy testing included cardiovascular autonomic reflex tests (CARTs) such as heart rate variability to obtain mean circular resultant (MCR), and the 30:15 stand up test to obtain postural index and blood pressure measurement to test for orthostatic hypotension

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
University General Hospital of Thessaloniki AHEPA	Thessaloniki, Central Macedonia	Greece

+Publications

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. PMID 32423173

+Investigators

Triantafyllos Didangelos, Professor, Study director, Aristotle University Of Thessaloniki