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

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

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

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 1; Diabetes type1
• Intervention / Treatment: Dietary supplement: dietary supplement with probiotics, prebiotics, magnesium and saffron extract; Dietary supplement: dietary supplement with probiotics, prebiotics, magnesium

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.

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Central Macedonia
    • Thessaloníki, Central Macedonia, Greece, 54636
      • University General Hospital of Thessaloniki AHEPA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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: 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; Other Names: Probiotics and saffron extract
Placebo Comparator: 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: 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 Names: Probiotics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
glycated hemoglobin	glycated hemoglobin %	6 months
blood glucose	Fasting blood glucose (mg/dl)	6 months
serum cholesterol	Total Cholesterol mg/dl	6 months
serum High density lipoprotein cholesterol	High density lipoprotein Cholesterol mg/dl	6 months
serum low density lipoprotein cholesterol	Low density lipoprotein cholesterol mg/dl	6 months
triglycerides	serum Triglycerides mg/dl	6 months
Systolic Blood pressure	Systolic blood pressure mmHg	6 months
Diastolic Blood pressure	Diastolic blood pressure mmHg	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Continuous glucose monitoring data	Time in range %	6 months
Continuous glucose monitoring time	Time below range %	6 months
Continuous glucose monitoring time data	Time above range %	6 months
Continuous glucose monitoring glycemic data	Glucose Management Indicator %	6 months
Continuous glucose monitoring statistic data	Coefficient of variance	6 months
Sural nerve conduction velocity	Nerve conduction velocity is measured in the sural sensory nerve of both feet with Neurometrix DPNCheck	6 months
Electrochemical skin conductance	Sudomotor function was assessed with SUDOSCAN, which measures electrochemical skin conductance in the feet (ESCF) and hands (ESCH)	6 months
Cardiovascular Autonomic Reflex tests	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	6 months

Collaborators and Investigators

• Sponsor: Aristotle University Of Thessaloniki
• Investigators: Study Director: Triantafyllos Didangelos, Professor, Aristotle University of Thessaloniki

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): April 28, 2023
• Study Completion (Actual): April 28, 2023

Study Registration Dates

• First Submitted: May 14, 2023
• First Submitted That Met QC Criteria: June 26, 2023
• First Posted (Actual): July 6, 2023

Study Record Updates

• Last Update Posted (Actual): July 9, 2025
• Last Update Submitted That Met QC Criteria: July 3, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: saffron; continuous glucose monitoring; diabetes type 1; saffron extract; diabetes mellitus type 1
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: Diabetes1Crocus; 1.46-21/11/2018 (Other Identifier: Aristotle University of Thessaloniki)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan for sharing individual participant data due to bioethics committee restrictions on personal data privacy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No