Effect of Camel Milk With Probiotic on Type 2 Diabetes Mellitus

Phase 1

Completed

• Conditions: Type 2 Diabetes
• Interventions: Dietary Supplement: Cow milk; Dietary Supplement: Camel milk; Dietary Supplement: Bifidobacterium animalis A6; Dietary Supplement: Camel milk containing Bifidobacterium animalis A6

• Registration Number: NCT04296825
• Lead Sponsor: China Agricultural University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-06
• Study Start: 2018-06-01
• Primary Completion: 2018-06-09
• Study Completion: 2018-07-09
• Study First Submitted: 2020-03-02
• Study First Submitted QC: 2020-03-03
• Last Update Submitted: 2020-03-03
• Study First Posted: 2020-03-05
• Last Update Posted: 2020-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
P	Cow milk	Patients received cow milk for 4 consecutive weeks (two times per day, 10 gram each time).
C	Camel milk	Patients received camel milk for 4 consecutive weeks (two times per day, 10 gram each time).
A	Bifidobacterium animalis A6	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).
CA	Camel milk containing Bifidobacterium animalis A6	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).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Changes in fecal microbiome	4 weeks	follow up the patients at week 0, 4
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 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 inflammation cytokines ( TNF-α, IL-6 and MCP-1 in petagram per milliliter)	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 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

Trial Locations

Locations (1)

Beijing Chinese Medicine Hospital Pinggu Hospital; 🇨🇳 Beijing, China