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

NCT ID: NCT05933460

Last Updated: 2025-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2023-04-28

Brief Summary

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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

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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

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Diabetes Mellitus, Type 1 Diabetes type1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double blind placebo controlled randomized trial
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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.

Study Groups

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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.

Group Type EXPERIMENTAL

dietary supplement with probiotics, prebiotics, magnesium and saffron extract

Intervention Type DIETARY_SUPPLEMENT

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

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.

Group Type PLACEBO_COMPARATOR

dietary supplement with probiotics, prebiotics, magnesium

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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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

Intervention Type 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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Probiotics and saffron extract Probiotics

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aristotle University Of Thessaloniki

OTHER

Sponsor Role lead

Responsible Party

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Prof. Triantafyllos Didangelos

Professor of Internal Medicine- Diabetology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Triantafyllos Didangelos, Professor

Role: STUDY_DIRECTOR

Aristotle University Of Thessaloniki

Locations

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University General Hospital of Thessaloniki AHEPA

Thessaloniki, Central Macedonia, Greece

Site Status

Countries

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Greece

References

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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.

Reference Type BACKGROUND
PMID: 32423173 (View on PubMed)

Other Identifiers

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1.46-21/11/2018

Identifier Type: OTHER

Identifier Source: secondary_id

Diabetes1Crocus

Identifier Type: -

Identifier Source: org_study_id

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