search
Back to results

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

Primary Purpose

Diabetes Mellitus, Type 1, Diabetes type1

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
dietary supplement with probiotics, prebiotics, magnesium and saffron extract
dietary supplement with probiotics, prebiotics, magnesium
Sponsored by
Aristotle University Of Thessaloniki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring diabetes mellitus type 1, diabetes type 1, saffron, saffron extract, continuous glucose monitoring

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University General Hospital of Thessaloniki AHEPA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active Group

Placebo group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Continuous glucose monitoring data
Time in range %
Continuous glucose monitoring time
Time below range %
Continuous glucose monitoring time data
Time above range %
Continuous glucose monitoring glycemic data
Glucose Management Indicator %
Continuous glucose monitoring statistic data
Coefficient of variance

Full Information

First Posted
May 14, 2023
Last Updated
June 26, 2023
Sponsor
Aristotle University Of Thessaloniki
search

1. Study Identification

Unique Protocol Identification Number
NCT05933460
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
April 28, 2023 (Actual)
Study Completion Date
April 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aristotle University Of Thessaloniki

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1, Diabetes type1
Keywords
diabetes mellitus type 1, diabetes type 1, saffron, saffron extract, continuous glucose monitoring

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double blind placebo controlled randomized trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
No participant or personnel knew the randomization process and the only knew did not had to do with participants or administration of supplement or collecting data. The company providing the supplement did not know either.
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
dietary supplement with probiotics, prebiotics, magnesium and saffron extract
Other Intervention Name(s)
Probiotics and saffron extract
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
dietary supplement with probiotics, prebiotics, magnesium
Other Intervention Name(s)
Probiotics
Intervention Description
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
Primary Outcome Measure Information:
Title
glycated hemoglobin
Description
glycated hemoglobin %
Time Frame
6 months
Title
blood glucose
Description
Fasting blood glucose (mg/dl)
Time Frame
6 months
Title
serum cholesterol
Description
Total Cholesterol mg/dl
Time Frame
6 months
Title
serum High density lipoprotein cholesterol
Description
High density lipoprotein Cholesterol mg/dl
Time Frame
6 months
Title
serum low density lipoprotein cholesterol
Description
Low density lipoprotein cholesterol mg/dl
Time Frame
6 months
Title
triglycerides
Description
serum Triglycerides mg/dl
Time Frame
6 months
Title
Systolic Blood pressure
Description
Systolic blood pressure mmHg
Time Frame
6 months
Title
Diastolic Blood pressure
Description
Diastolic blood pressure mmHg
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Continuous glucose monitoring data
Description
Time in range %
Time Frame
6 months
Title
Continuous glucose monitoring time
Description
Time below range %
Time Frame
6 months
Title
Continuous glucose monitoring time data
Description
Time above range %
Time Frame
6 months
Title
Continuous glucose monitoring glycemic data
Description
Glucose Management Indicator %
Time Frame
6 months
Title
Continuous glucose monitoring statistic data
Description
Coefficient of variance
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Triantafyllos Didangelos, Professor
Organizational Affiliation
Aristotle University Of Thessaloniki
Official's Role
Study Director
Facility Information:
Facility Name
University General Hospital of Thessaloniki AHEPA
City
Thessaloníki
State/Province
Central Macedonia
ZIP/Postal Code
54636
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan for sharing individual participant data due to bioethics committee restrictions on personal data privacy
Citations:
PubMed Identifier
32423173
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs