Diabetes Mellitus, Type 1NCT05933460
Crocus Sativus Extract Impact in Metabolic Control of Patients With Diabetes Mellitus Type 1
A study testing dietary supplement with probiotics, prebiotics, magnesium and saffron extract and dietary supplement with probiotics, prebiotics, magnesium in people with Diabetes Mellitus, Type 1 and Diabetes type1, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1, Diabetes type1
- What is being tested?
- dietary supplement with probiotics, prebiotics, magnesium and saffron extract and dietary supplement with probiotics, prebiotics, magnesium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteGreece
- Study dates
- 1 Mar 2022to 28 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Greece1 site
University General Hospital of Thessaloniki AHEPA
Thessaloniki, Central Macedonia, 54636
About this study
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
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
Read the 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.
- Conditions
- Diabetes Mellitus, Type 1, Diabetes type1
- Being tested
- dietary supplement with probiotics, prebiotics, magnesium and saffron extract, dietary supplement with probiotics, prebiotics, magnesium
- Keywords
- diabetes mellitus type 1, diabetes type 1, saffron, saffron extract, continuous glucose monitoring
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary supplement with probiotics, prebiotics, magnesium and saffron extractDietary supplement
Also called 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, magnesiumDietary supplement
Also called 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
| Study group | Role | What they receive |
|---|---|---|
| Active Group | Experimental | 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. Receives: Dietary Supplement: dietary supplement with probiotics, prebiotics, magnesium and saffron extract |
| Placebo group | Placebo comparator | 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. Receives: Dietary Supplement: dietary supplement with probiotics, prebiotics, magnesium |
What is being measured
The primary outcome is the main question the study is designed to answer.
glycated hemoglobin
glycated hemoglobin %
Measured: 6 months
blood glucose
Fasting blood glucose (mg/dl)
Measured: 6 months
serum cholesterol
Total Cholesterol mg/dl
Measured: 6 months
serum High density lipoprotein cholesterol
High density lipoprotein Cholesterol mg/dl
Measured: 6 months
serum low density lipoprotein cholesterol
Low density lipoprotein cholesterol mg/dl
Measured: 6 months
triglycerides
serum Triglycerides mg/dl
Measured: 6 months
Systolic Blood pressure
Systolic blood pressure mmHg
Measured: 6 months
Diastolic Blood pressure
Diastolic blood pressure mmHg
Measured: 6 months
Secondary outcomes (8)
Continuous glucose monitoring data
Time in range %
Measured: 6 months
Continuous glucose monitoring time
Time below range %
Measured: 6 months
Continuous glucose monitoring time data
Time above range %
Measured: 6 months
Continuous glucose monitoring glycemic data
Glucose Management Indicator %
Measured: 6 months
Continuous glucose monitoring statistic data
Coefficient of variance
Measured: 6 months
Sural nerve conduction velocity
Nerve conduction velocity is measured in the sural sensory nerve of both feet with Neurometrix DPNCheck
Measured: 6 months
Electrochemical skin conductance
Sudomotor function was assessed with SUDOSCAN, which measures electrochemical skin conductance in the feet (ESCF) and hands (ESCH)
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start1 Mar 2022
- Primary completion28 Apr 2023
- Study completion28 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind placebo controlled randomized trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Triantafyllos Didangelos, Aristotle University Of Thessaloniki
- Investigators
- Triantafyllos Didangelos, Professor, Study director, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05933460
- Sponsor's protocol ID
- Diabetes1Crocus
- Other IDs
- 1.46-21/11/2018
- Status last verified
- Jul 2025
- First submitted
- 14 May 2023
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan for sharing individual participant data due to bioethics committee restrictions on personal data privacy
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.
PubMed 32423173
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05933460
- Acronym / sponsor ID
- Diabetes1Crocus
- Conditions
- Diabetes Mellitus, Type 1, Diabetes type1
- Keywords
- diabetes mellitus type 1, diabetes type 1, saffron, saffron extract, continuous glucose monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 28 Apr 2023 (actual)
- Study completion
- 28 Apr 2023 (actual)
- First posted
- 6 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blind placebo controlled randomized trial
| Arm | Type | Receives |
|---|---|---|
| Active Group | Experimental | Dietary Supplement: dietary supplement with probiotics, prebiotics, magnesium and saffron extractA 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, magnesiumA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (8 listed)
- Pregnant
- People with diabetes mellitus type 2
- Breastfeeding women
- People with liver disease
- People with chronic kidney disease (over stage 3)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dietary supplement with probiotics, prebiotics, magnesium and saffron extractAlso: Probiotics and saffron extractA 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 | Active Group |
| dietary supplement with probiotics, prebiotics, magnesiumAlso: ProbioticsA 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 | Dietary supplement | Placebo group |
Primary outcome
glycated hemoglobin
Time frame: 6 months
glycated hemoglobin %
blood glucose
Time frame: 6 months
Fasting blood glucose (mg/dl)
serum cholesterol
Time frame: 6 months
Total Cholesterol mg/dl
serum High density lipoprotein cholesterol
Time frame: 6 months
High density lipoprotein Cholesterol mg/dl
serum low density lipoprotein cholesterol
Time frame: 6 months
Low density lipoprotein cholesterol mg/dl
triglycerides
Time frame: 6 months
serum Triglycerides mg/dl
Systolic Blood pressure
Time frame: 6 months
Systolic blood pressure mmHg
Diastolic Blood pressure
Time frame: 6 months
Diastolic blood pressure mmHg
8 secondary outcomes
Continuous glucose monitoring data
Time frame: 6 months
Continuous glucose monitoring time
Time frame: 6 months
Continuous glucose monitoring time data
Time frame: 6 months
Continuous glucose monitoring glycemic data
Time frame: 6 months
Continuous glucose monitoring statistic data
Time frame: 6 months
Sural nerve conduction velocity
Time frame: 6 months
Electrochemical skin conductance
Time frame: 6 months
Cardiovascular Autonomic Reflex tests
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Background: PubMed 32423173Giannoulaki 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.
- Individual participant dataSharing planned: No. There is no plan for sharing individual participant data due to bioethics committee restrictions on personal data privacy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Triantafyllos Didangelos, Professor study director
Aristotle University Of Thessaloniki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dietary supplement with probiotics, prebiotics, magnesium and saffron extract and dietary supplement with probiotics, prebiotics, magnesium in people with Diabetes Mellitus, Type 1 and Diabetes type1, run by Aristotle University Of Thessaloniki at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
glycated hemoglobin (time frame: 6 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05933460, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.