Trial | NCT04296825  Report issue

Title

Effect of Camel Milk With Probiotic on Type 2 Diabetes Mellitus
Effect of Camel Milk Containing Bifidobacterium Animalis A6 on Chinese People With Type 2 Diabetes Mellitus

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    45
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.
Study Started
Jun 01
2018
Primary Completion
Jun 09
2018
Study Completion
Jul 09
2018
Last Update
Mar 05
2020

Dietary Supplement Camel milk containing Bifidobacterium animalis A6 [camel milk, bifidobacterium animalis]

Take the interventions about 30 minutes after meals in the morning and evening for 4 consecutive weeks.

Dietary Supplement Camel milk

Take the interventions about 30 minutes after meals in the morning and evening for 4 consecutive weeks.

Dietary Supplement Bifidobacterium animalis A6

Take the interventions about 30 minutes after meals in the morning and evening for 4 consecutive weeks.

Dietary Supplement Cow milk

Take the interventions about 30 minutes after meals in the morning and evening for 4 consecutive weeks.

P Placebo Comparator

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

CA Active Comparator

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).

C Experimental

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

A Experimental

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).

Criteria 

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
No Results Posted