Type 2 Diabetes
Conditions
Keywords
Camel Milk, Probiotics, Gut Microbiome
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.
Interventions
DIETARY_SUPPLEMENTCamel milk containing Bifidobacterium animalis A6
Take the interventions about 30 minutes after meals in the morning and evening for 4 consecutive weeks.
DIETARY_SUPPLEMENTCamel milk
Take the interventions about 30 minutes after meals in the morning and evening for 4 consecutive weeks.
DIETARY_SUPPLEMENTBifidobacterium animalis A6
Take the interventions about 30 minutes after meals in the morning and evening for 4 consecutive weeks.
DIETARY_SUPPLEMENTCow milk
Take the interventions about 30 minutes after meals in the morning and evening for 4 consecutive weeks.
Sponsors
Beijing Chinese Medicine Hospital-Pinggu Hospital
China Agricultural University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 68 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in fasting blood glucose and 2 hour postprandial blood glucose in millimole per liter and insulin in μU/mL | 4 weeks | follow up the patients at week 0, 4 |
| Changes in lipid profiles (total cholesterol, total triglyceride, high-density lipoprotein cholesterol and low-density lipoprotein cholesterol in millimole per liter) | 4 weeks | follow up the patients at week 0, 4 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 4 weeks | follow up the patients at week 0, 4 |
| 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). ) | 4 weeks | follow up the patients at week 0, 4 |
| Changes in fecal microbiome | 4 weeks | follow up the patients at week 0, 4 |
| Changes in gut hormones (amylin, ghrelin, GLP-1, PP and PYY in petagram per milliliter) | 4 weeks | follow up the patients at week 0, 4 |
| 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) | 4 weeks | follow up the patients at week 0, 4 |
| Changes in inflammation cytokines ( TNF-α, IL-6 and MCP-1 in petagram per milliliter) | 4 weeks | follow up the patients at week 0, 4 |
Countries
China
Outcome results
None listed