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

Sponsor
Aristotle University Of Thessaloniki (Other)
Overall Status
Completed
CT.gov ID
NCT05933460
Collaborator
(none)
61
Enrollment
1
Location
2
Arms
13.9
Actual Duration (Months)
4.4
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: dietary supplement with probiotics, prebiotics, magnesium and saffron extract
  • Dietary Supplement: dietary supplement with probiotics, prebiotics, magnesium
 N/A

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

Study Type:
Interventional
Actual Enrollment :
61 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Double blind placebo controlled randomized trialDouble blind placebo controlled randomized trial
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes 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.
Primary Purpose:
Treatment
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
Actual Study Start Date :
Mar 1, 2022
Actual Primary Completion Date :
Apr 28, 2023
Actual Study Completion Date :
Apr 28, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. glycated hemoglobin [6 months]

      glycated hemoglobin %

    2. blood glucose [6 months]

      Fasting blood glucose (mg/dl)

    3. serum cholesterol [6 months]

      Total Cholesterol mg/dl

    4. serum High density lipoprotein cholesterol [6 months]

      High density lipoprotein Cholesterol mg/dl

    5. serum low density lipoprotein cholesterol [6 months]

      Low density lipoprotein cholesterol mg/dl

    6. triglycerides [6 months]

      serum Triglycerides mg/dl

    7. Systolic Blood pressure [6 months]

      Systolic blood pressure mmHg

    8. Diastolic Blood pressure [6 months]

      Diastolic blood pressure mmHg

    Secondary Outcome Measures

    1. Continuous glucose monitoring data [6 months]

      Time in range %

    2. Continuous glucose monitoring time [6 months]

      Time below range %

    3. Continuous glucose monitoring time data [6 months]

      Time above range %

    4. Continuous glucose monitoring glycemic data [6 months]

      Glucose Management Indicator %

    5. Continuous glucose monitoring statistic data [6 months]

      Coefficient of variance

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University General Hospital of Thessaloniki AHEPA Thessaloníki Central Macedonia Greece 54636

    Sponsors and Collaborators

    • Aristotle University Of Thessaloniki

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Prof. Triantafyllos Didangelos, Professor of Internal Medicine- Diabetology, Aristotle University Of Thessaloniki
    ClinicalTrials.gov Identifier:
    NCT05933460
    Other Study ID Numbers:
    • Diabetes1Crocus
    • 1.46-21/11/2018
    First Posted:
    Jul 6, 2023
    Last Update Posted:
    Jul 6, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Prof. Triantafyllos Didangelos, Professor of Internal Medicine- Diabetology, Aristotle University Of Thessaloniki
    diabetes mellitus type 1
    diabetes type 1
    saffron
    saffron extract
    continuous glucose monitoring
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 1

    Study Results

    No Results Posted as of Jul 6, 2023