Effect of Camel Milk With Probiotic on Type 2 Diabetes Mellitus

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

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 Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Dietary supplement: Cow milk; Dietary supplement: Camel milk containing Bifidobacterium animalis A6; Dietary supplement: Camel milk; Dietary supplement: Bifidobacterium animalis A6

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Chinese Medicine Hospital Pinggu Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: P; Patients received cow milk for 4 consecutive weeks (two times per day, 10 gram each time).	Dietary supplement: Cow milk; Take the interventions about 30 minutes after meals in the morning and evening for 4 consecutive weeks.
Active Comparator: CA; 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; Take the interventions about 30 minutes after meals in the morning and evening for 4 consecutive weeks.
Experimental: C; Patients received camel milk for 4 consecutive weeks (two times per day, 10 gram each time).	Dietary supplement: Camel milk; Take the interventions about 30 minutes after meals in the morning and evening for 4 consecutive weeks.
Experimental: A; 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; Take the interventions about 30 minutes after meals in the morning and evening for 4 consecutive weeks.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: China Agricultural University
• Collaborators: Beijing Chinese Medicine Hospital-Pinggu Hospital

Publications and helpful links

General Publications

• Auer HE, Doty P. The synthesis, structure, and optical properties of some copolypeptides containing nonpolar amino acid residues. Biochemistry. 1966 May;5(5):1708-15. doi: 10.1021/bi00869a037. No abstract available.
• Agrawal RP, Budania S, Sharma P, Gupta R, Kochar DK, Panwar RB, Sahani MS. Zero prevalence of diabetes in camel milk consuming Raica community of north-west Rajasthan, India. Diabetes Res Clin Pract. 2007 May;76(2):290-6. doi: 10.1016/j.diabres.2006.09.036. Epub 2006 Nov 13.
• Saigusa M, Mizuno A, Morimoto K, Nakamura K. [Acute postoperative renal failure due to extracorporeal circulation--with reference to the evaluation of fatal cases]. Kyobu Geka. 1967 Sep;20(9):594-9. No abstract available. Japanese.
• Casini F, Sbarigia V, Schiavone C. [Identification of Cannabis indica in the residues of incomplete combustion of the drug]. Boll Chim Farm. 1969 May;108(5):330-6. No abstract available. Italian.
• Baumgarten A, Melrose GJ, Vagg WJ. Continuous recording of dermal exudative reactions. Dermatologica. 1970;140(4):219-24. doi: 10.1159/000252557. No abstract available.
• Burdon JF. [Medicine in Great Britain]. Concours Med. 1965 Oct 9;87(41):5799-803. No abstract available. French.
• Lavin MF, Seymour GJ. Reduced levels of fibronectin in ataxia-telangiectasia lymphoblastoid cells. Int J Cancer. 1984 Mar 15;33(3):359-63. doi: 10.1002/ijc.2910330313.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): June 9, 2018
• Study Completion (Actual): July 9, 2018

Study Registration Dates

• First Submitted: March 2, 2020
• First Submitted That Met QC Criteria: March 3, 2020
• First Posted (Actual): March 5, 2020

Study Record Updates

• Last Update Posted (Actual): March 5, 2020
• Last Update Submitted That Met QC Criteria: March 3, 2020
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Probiotics; Gut Microbiome; Camel Milk
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: FDLT2DM-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No