Clinical trial NCT04296825: Effect of Camel Milk With Probiotic on Type 2 Diabetes Mellitus
Official title: Effect of Camel Milk Containing Bifidobacterium Animalis A6 on Chinese People With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes
Keywords: Camel Milk
Probiotics
Gut Microbiome
Lead sponsor: China Agricultural University
Sponsor class: OTHER
Collaborators: name: Beijing Chinese Medicine Hospital-Pinggu Hospital
First posted: 2020-03-05
Enrollment: 45
Sex: ALL
Minimum age (years): 35
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Changes in fasting blood glucose and 2 hour postprandial blood glucose in millimole per liter and insulin in μU/mL
timeFrame: 4 weeks
measure: Changes in lipid profiles (total cholesterol, total triglyceride, high-density lipoprotein cholesterol and low-density lipoprotein cholesterol in millimole per liter)
timeFrame: 4 weeks
Secondary outcomes:
measure: Changes in inflammation cytokines ( TNF-α, IL-6 and MCP-1 in petagram per milliliter)
timeFrame: 4 weeks
measure: Changes in fecal microbiome
timeFrame: 4 weeks
measure: 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.
timeFrame: 4 weeks
measure: 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). )
timeFrame: 4 weeks
measure: 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)
timeFrame: 4 weeks
measure: Changes in gut hormones (amylin, ghrelin, GLP-1, PP and PYY in petagram per milliliter)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chinese Medicine Hospital Pinggu Hospital
Study officials:
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