Effect of Camel Milk With Probiotic on Type 2 Diabetes Mellitus

NCT04296825 | Completed Phase 1 DMC

• 1 other identifier: FDLT2DM-01
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

Camel Milk; Probiotics; Gut Microbiome

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Changes in inflammation cytokines ( TNF-α, IL-6 and MCP-1 in petagram per milliliter)

  4 weeks

• Changes in fecal microbiome

  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.

  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). )

  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)

  4 weeks

Study Arms (4)

P

PLACEBO COMPARATOR

Patients received cow milk for 4 consecutive weeks (two times per day, 10 gram each time).

Dietary Supplement: Cow milk

CA

ACTIVE COMPARATOR

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

C

EXPERIMENTAL

Patients received camel milk for 4 consecutive weeks (two times per day, 10 gram each time).

Dietary Supplement: Camel milk

A

EXPERIMENTAL

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

Interventions

Camel milk containing Bifidobacterium animalis A6 DIETARY_SUPPLEMENT

Take the interventions about 30 minutes after meals in the morning and evening for 4 consecutive weeks.

CA

Camel milk DIETARY_SUPPLEMENT

Take the interventions about 30 minutes after meals in the morning and evening for 4 consecutive weeks.

C

Bifidobacterium animalis A6 DIETARY_SUPPLEMENT

Take the interventions about 30 minutes after meals in the morning and evening for 4 consecutive weeks.

A

Cow milk DIETARY_SUPPLEMENT

Take the interventions about 30 minutes after meals in the morning and evening for 4 consecutive weeks.

P

Eligibility Criteria

• Age: 35 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• China Agricultural University: lead
• Beijing Chinese Medicine Hospital-Pinggu Hospital: collaborator

Study Sites (1)

Beijing Chinese Medicine Hospital Pinggu Hospital

Beijing, China

Location

Related Publications (7)

• 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.

  PMID: 5961288 BACKGROUND

• 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.

  PMID: 17098321 RESULT

• 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.

  PMID: 5626114 RESULT

• 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.

  PMID: 5806827 RESULT

• 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.

  PMID: 5425915 RESULT

• Burdon JF. [Medicine in Great Britain]. Concours Med. 1965 Oct 9;87(41):5799-803. No abstract available. French.

  PMID: 5857053 RESULT

• 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.

  PMID: 6365801 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Milk

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: March 5, 2020
• Study Start: June 1, 2018
• Primary Completion: June 9, 2018
• Study Completion: July 9, 2018
• Last Updated: March 5, 2020

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)