Effect of Camel Milk With Probiotic on Type 2 Diabetes Mellitus

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04296825
• Other study ID #: FDLT2DM-01
• Status: Completed
• Phase: Phase 1
• Start date: June 1, 2018
• Est. completion date: July 9, 2018

Study information

• Verified date: June 2018
• Source: China Agricultural University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: July 9, 2018
• Est. primary completion date: June 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 68 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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.
• Camel milk
Take the interventions about 30 minutes after meals in the morning and evening for 4 consecutive weeks.
• Bifidobacterium animalis A6
Take the interventions about 30 minutes after meals in the morning and evening for 4 consecutive weeks.
• Cow milk
Take the interventions about 30 minutes after meals in the morning and evening for 4 consecutive weeks.

Locations

Country	Name	City	State
China	Beijing Chinese Medicine Hospital Pinggu Hospital	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
China Agricultural University	Beijing Chinese Medicine Hospital-Pinggu Hospital

Country where clinical trial is conducted

China, 

References & Publications (7)

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. Epub 2006 Nov 13. — View Citation

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. — View Citation

Baumgarten A, Melrose GJ, Vagg WJ. Continuous recording of dermal exudative reactions. Dermatologica. 1970;140(4):219-24. — View Citation

Burdon JF. [Medicine in Great Britain]. Concours Med. 1965 Oct 9;87(41):5799-803. French. — View Citation

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. Italian. — View Citation

Lavin MF, Seymour GJ. Reduced levels of fibronectin in ataxia-telangiectasia lymphoblastoid cells. Int J Cancer. 1984 Mar 15;33(3):359-63. — View Citation

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. Japanese. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Changes in inflammation cytokines ( TNF-a, IL-6 and MCP-1 in petagram per milliliter)	follow up the patients at week 0, 4	4 weeks
Secondary	Changes in fecal microbiome	follow up the patients at week 0, 4	4 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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