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

NCT05933460 | Completed

• 2 other identifiers: Diabetes1Crocus1.46-21/11/2018
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetes Mellitus, Type 1; Diabetes type1

Keywords

diabetes mellitus type 1; diabetes type 1; saffron; saffron extract; continuous glucose monitoring

Outcome Measures

Primary Outcomes (8)

• glycated hemoglobin

  glycated hemoglobin %

  6 months

• blood glucose

  Fasting blood glucose (mg/dl)

  6 months

• serum cholesterol

  Total Cholesterol mg/dl

  6 months

• serum High density lipoprotein cholesterol

  High density lipoprotein Cholesterol mg/dl

  6 months

• serum low density lipoprotein cholesterol

  Low density lipoprotein cholesterol mg/dl

  6 months

• triglycerides

  serum Triglycerides mg/dl

  6 months

• Systolic Blood pressure

  Systolic blood pressure mmHg

  6 months

• Diastolic Blood pressure

  Diastolic blood pressure mmHg

  6 months

Secondary Outcomes (8)

• Continuous glucose monitoring data

  6 months

• Continuous glucose monitoring time

  6 months

• Continuous glucose monitoring time data

  6 months

• Continuous glucose monitoring glycemic data

  6 months

• Continuous glucose monitoring statistic data

  6 months

Study Arms (2)

Active Group

EXPERIMENTAL

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

Placebo group

PLACEBO COMPARATOR

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

Interventions

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

Also known as: Probiotics and saffron extract

Active Group

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

Also known as: Probiotics

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

University General Hospital of Thessaloniki AHEPA

Thessaloniki, Central Macedonia, 54636, Greece

Location

Related Publications (1)

• 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.

  PMID: 32423173 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Dietary Supplements; Probiotics; Prebiotics; Magnesium

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides; Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals, Light; Metals

Study Officials

• Triantafyllos Didangelos, Professor

  Aristotle University Of Thessaloniki

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Internal Medicine- Diabetology

Model Details: Double blind placebo controlled randomized trial

Study Record Dates

• First Submitted: May 14, 2023
• First Posted: July 6, 2023
• Study Start: March 1, 2022
• Primary Completion: April 28, 2023
• Study Completion: April 28, 2023
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)