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

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 1; Diabetes type1
• Interventions: Dietary Supplement: dietary supplement with probiotics, prebiotics, magnesium; Dietary Supplement: dietary supplement with probiotics, prebiotics, magnesium and saffron extract

• Registration Number: NCT05933460
• Lead Sponsor: Aristotle University Of Thessaloniki

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

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 Timeline

• Study Start: 2022-03-01
• Primary Completion: 2023-04-28
• Study Completion: 2023-04-28
• Study First Submitted: 2023-05-14
• Status Verified: 2023-06
• Study First Submitted QC: 2023-06-26
• Last Update Submitted: 2023-06-26
• Study First Posted: 2023-07-06
• Last Update Posted: 2023-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	dietary supplement with probiotics, prebiotics, magnesium	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.
Active Group	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 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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Continuous glucose monitoring data	6 months	Time in range %
Continuous glucose monitoring statistic data	6 months	Coefficient of variance
Continuous glucose monitoring time data	6 months	Time above range %
Continuous glucose monitoring time	6 months	Time below range %
Continuous glucose monitoring glycemic data	6 months	Glucose Management Indicator %

Trial Locations

Locations (1)

University General Hospital of Thessaloniki AHEPA; 🇬🇷 Thessaloníki, Central Macedonia, Greece