Effect of Camel Milk With Probiotic on Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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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.

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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Dietary Supplement: Camel milk containing Bifidobacterium animalis A6
* Dietary Supplement: Camel milk
* Dietary Supplement: Bifidobacterium animalis A6
* Dietary Supplement: Cow milk


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 68 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: P<br>Patients received cow milk for 4 consecutive weeks (two times per day, 10 gram each time). | Dietary Supplement: Cow milk<br>* Take the interventions about 30 minutes after meals in the morning and evening for 4 consecutive weeks.<br>|
| Active Comparator: CA<br>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). | Dietary Supplement: Camel milk containing Bifidobacterium animalis A6<br>* Take the interventions about 30 minutes after meals in the morning and evening for 4 consecutive weeks.<br>|
| Experimental: C<br>Patients received camel milk for 4 consecutive weeks (two times per day, 10 gram each time). | Dietary Supplement: Camel milk<br>* Take the interventions about 30 minutes after meals in the morning and evening for 4 consecutive weeks.<br>|
| Experimental: A<br>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). | Dietary Supplement: Bifidobacterium animalis A6<br>* Take the interventions about 30 minutes after meals in the morning and evening for 4 consecutive weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in fasting blood glucose and 2 hour postprandial blood glucose in millimole per liter and insulin in μU/mL | follow up the patients at week 0, 4 | 4 weeks | 
| Changes in lipid profiles (total cholesterol, total triglyceride, high-density lipoprotein cholesterol and low-density lipoprotein cholesterol in millimole per liter) | follow up the patients at week 0, 4 | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in inflammation cytokines ( TNF-α, IL-6 and MCP-1 in petagram per milliliter) | follow up the patients at week 0, 4 | 4 weeks | 
| Changes in fecal microbiome | follow up the patients at week 0, 4 | 4 weeks | 
| Fecal metabolites were identified by GC-MS after extracted with methanol, then oximated with methoxyamine hydrochloride and trimethylsilylated with BSTFA. The concentration was calculated as the area of the peak and normalized to the internal standard. | follow up the patients at week 0, 4 | 4 weeks | 
| Changes in body composition (bodyweight in kilograms, height in meters and visceral fat content in square centimeters and body fat in % were measured using the bioelectrical impedance method (BAS-H, SEEHIGHER, Beijing China). ) | follow up the patients at week 0, 4 | 4 weeks | 
| Changes in myokines (FGF21, irisin, osteocrin, and osteonectin in petagram per milliliter) and adipokines (adiponectin and adipsin in microgram per milliliter and resistin and lipocalin-2 in petagram per milliliter) | follow up the patients at week 0, 4 | 4 weeks | 
| Changes in gut hormones (amylin, ghrelin, GLP-1, PP and PYY in petagram per milliliter) | follow up the patients at week 0, 4 | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Camel Milk, Probiotics, Gut Microbiome