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Completed

NCT Number: NCT05933460

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

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

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Diabetes type1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University General Hospital of Thessaloniki AHEPA

Thessaloniki, Central Macedonia, 54636, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dietary supplement with probiotics, prebiotics, magnesium and saffron extract

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

Other names: Probiotics and saffron extract

dietary supplement with probiotics, prebiotics, magnesium

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

Other names: Probiotics

Primary outcomes

  1. glycated hemoglobin

    Time frame: 6 months

    glycated hemoglobin %

  2. blood glucose

    Time frame: 6 months

    Fasting blood glucose (mg/dl)

  3. serum cholesterol

    Time frame: 6 months

    Total Cholesterol mg/dl

  4. serum High density lipoprotein cholesterol

    Time frame: 6 months

    High density lipoprotein Cholesterol mg/dl

  5. serum low density lipoprotein cholesterol

    Time frame: 6 months

    Low density lipoprotein cholesterol mg/dl

  6. triglycerides

    Time frame: 6 months

    serum Triglycerides mg/dl

  7. Systolic Blood pressure

    Time frame: 6 months

    Systolic blood pressure mmHg

  8. Diastolic Blood pressure

    Time frame: 6 months

    Diastolic blood pressure mmHg

Secondary outcomes

  1. Continuous glucose monitoring data

    Time frame: 6 months

    Time in range %

  2. Continuous glucose monitoring time

    Time frame: 6 months

    Time below range %

  3. Continuous glucose monitoring time data

    Time frame: 6 months

    Time above range %

  4. Continuous glucose monitoring glycemic data

    Time frame: 6 months

    Glucose Management Indicator %

  5. Continuous glucose monitoring statistic data

    Time frame: 6 months

    Coefficient of variance

  6. Sural nerve conduction velocity

    Time frame: 6 months

    Nerve conduction velocity is measured in the sural sensory nerve of both feet with Neurometrix DPNCheck

  7. Electrochemical skin conductance

    Time frame: 6 months

    Sudomotor function was assessed with SUDOSCAN, which measures electrochemical skin conductance in the feet (ESCF) and hands (ESCH)

  8. Cardiovascular Autonomic Reflex tests

    Time frame: 6 months

    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

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Registry information

Official study title

Investigation of the Impact of the Administration of Crocus Sativus L Extract on the Metabolic Control of Patients With Type 1 Diabetes Mellitus

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 6, 2023
Registry last updated
Jul 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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