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

June 26, 2023 updated by: Prof. Triantafyllos Didangelos, Aristotle University Of Thessaloniki

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Continuous glucose monitoring data
Time Frame: 6 months
Time in range %
6 months
Continuous glucose monitoring time
Time Frame: 6 months
Time below range %
6 months
Continuous glucose monitoring time data
Time Frame: 6 months
Time above range %
6 months
Continuous glucose monitoring glycemic data
Time Frame: 6 months
Glucose Management Indicator %
6 months
Continuous glucose monitoring statistic data
Time Frame: 6 months
Coefficient of variance
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aristotle University Of Thessaloniki

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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 6, 2023

Last Update Submitted That Met QC Criteria

June 26, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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