Effect of Camel Milk With Probiotic on Type 2 Diabetes Mellitus

China Agricultural University

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes

Treatments: Dietary Supplement: Cow milk; Dietary Supplement: Camel milk containing Bifidobacterium animalis A6; Dietary Supplement: Camel milk; Dietary Supplement: Bifidobacterium animalis A6

Study type: Interventional

Funder types: Other

Identifiers

NCT04296825

FDLT2DM-01

Details and patient eligibility

About

The purpose of this study is to investigate the effects of dietary supplement with Camel Milk containing Bifidobacterium animalis A6 on the plasma glucose and other related cytokines in patients with type 2 diabetes mellitus. 45 patients with type 2 diabetes mellitus were recruited, and a Double Blind Randomized Parallel Controlled Trial was performed. The fasting glycaemia, 2 hour postprandial glycaemia, insulin, uric acid and serum lipid (total cholesterol, total triglyceride, high-density lipoprotein cholesterol and low-density lipoprotein cholesterol ) were measured as Primary Outcome. The Fecal microbiome, fecal metabolites, gut hormones (amylin, ghrelin, glucagon-like peptide 1, pancreatic polypeptide), inflammation cytokines (TNF-α, IL-6, MCP-1), myokines (FGF-21, irisin, osteocrin/musclin, osteonectin) and adipokines (adiponectin, resistin, lipocalin-2, adipsin) and body composition analysis were also assessed.

Enrollment: 45 patients

Sex: All

Ages: 35 to 68 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 35~68 years old
• Patients who diagnosed as type 2 diabetes
• Agree to take the products to be studied during the study period, and no longer take other fermented dairy products (live lactic acid bacteria drinks, cheese, yogurt, probiotic products, etc.) and antibiotic
• Agree to sign the informed consent form

Exclusion criteria

• Taking antibiotics or antifungal drugs within 7 days before the study
• Have serious allergic reaction to skim milk powder or milk
• Researcher are not sure whether the subjects are willing or able to complete the study
• Subject had other serious diseases

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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45 participants in 4 patient groups, including a placebo group

P

Placebo Comparator group

Description:

Patients received cow milk for 4 consecutive weeks (two times per day, 10 gram each time).

Treatment:

Dietary Supplement: Cow milk

CA

Active Comparator group

Description:

Patients received camel milk with Bifidobacterium animalis A6 at a dose of 2×1010 viable cells for 4 consecutive weeks (two times per day, 10 gram each time).

Treatment:

Dietary Supplement: Camel milk containing Bifidobacterium animalis A6

C

Experimental group

Description:

Patients received camel milk for 4 consecutive weeks (two times per day, 10 gram each time).

Treatment:

Dietary Supplement: Camel milk

A

Experimental group

Description:

Patients received Bifidobacterium animalis A6 at a dose of 2×1010 viable cells for 4 consecutive weeks (two times per day, 10 gram each time).

Treatment:

Dietary Supplement: Bifidobacterium animalis A6