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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
45
Take the interventions about 30 minutes after meals in the morning and evening for 4 consecutive weeks.
Take the interventions about 30 minutes after meals in the morning and evening for 4 consecutive weeks.
Take the interventions about 30 minutes after meals in the morning and evening for 4 consecutive weeks.
Take the interventions about 30 minutes after meals in the morning and evening for 4 consecutive weeks.
Beijing Chinese Medicine Hospital Pinggu Hospital
Beijing, China
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
Time frame: 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
Time frame: 4 weeks
Changes in inflammation cytokines ( TNF-α, IL-6 and MCP-1 in petagram per milliliter)
follow up the patients at week 0, 4
Time frame: 4 weeks
Changes in fecal microbiome
follow up the patients at week 0, 4
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 4 weeks
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