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

Aristotle University Of Thessaloniki

Status: Completed

Conditions: Diabetes Mellitus, Type 1; Diabetes type1

Treatments: Dietary Supplement: dietary supplement with probiotics, prebiotics, magnesium; Dietary Supplement: dietary supplement with probiotics, prebiotics, magnesium and saffron extract

Study type: Interventional

Funder types: Other

Identifiers

NCT05933460

1.46-21/11/2018 (Other Identifier)

Diabetes1Crocus

Details and patient eligibility

About

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

Full 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.

Enrollment: 61 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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61 participants in 2 patient groups, including a placebo group

Active Group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: dietary supplement with probiotics, prebiotics, magnesium and saffron extract

Placebo group

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: dietary supplement with probiotics, prebiotics, magnesium