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

Diabetes Mellitus, Type 1 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05933460
• Other study ID #: Diabetes1Crocus
• Secondary ID: 1.46-21/11/2018
• Status: Completed
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: April 28, 2023

Study information

• Verified date: June 2023
• Source: Aristotle University Of Thessaloniki
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: April 28, 2023
• Est. primary completion date: April 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes type1

Intervention

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 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

Locations

Country	Name	City	State
Greece	University General Hospital of Thessaloniki AHEPA	Thessaloníki	Central Macedonia

Sponsors (1)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	glycated hemoglobin	glycated hemoglobin %	6 months
Primary	blood glucose	Fasting blood glucose (mg/dl)	6 months
Primary	serum cholesterol	Total Cholesterol mg/dl	6 months
Primary	serum High density lipoprotein cholesterol	High density lipoprotein Cholesterol mg/dl	6 months
Primary	serum low density lipoprotein cholesterol	Low density lipoprotein cholesterol mg/dl	6 months
Primary	triglycerides	serum Triglycerides mg/dl	6 months
Primary	Systolic Blood pressure	Systolic blood pressure mmHg	6 months
Primary	Diastolic Blood pressure	Diastolic blood pressure mmHg	6 months
Secondary	Continuous glucose monitoring data	Time in range %	6 months
Secondary	Continuous glucose monitoring time	Time below range %	6 months
Secondary	Continuous glucose monitoring time data	Time above range %	6 months
Secondary	Continuous glucose monitoring glycemic data	Glucose Management Indicator %	6 months
Secondary	Continuous glucose monitoring statistic data	Coefficient of variance	6 months