Effect of Camel Milk With Probiotic on Type 2 Diabetes Mellitus

NCT ID: NCT04296825

Last Updated: 2020-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2018-07-09

Brief Summary

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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

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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P

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

Group Type PLACEBO_COMPARATOR

Cow milk

Intervention Type DIETARY_SUPPLEMENT

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

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).

Group Type ACTIVE_COMPARATOR

Camel milk containing Bifidobacterium animalis A6

Intervention Type DIETARY_SUPPLEMENT

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

C

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

Group Type EXPERIMENTAL

Camel milk

Intervention Type DIETARY_SUPPLEMENT

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

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).

Group Type EXPERIMENTAL

Bifidobacterium animalis A6

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Camel milk containing Bifidobacterium animalis A6

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

Intervention Type DIETARY_SUPPLEMENT

Camel milk

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

Intervention Type DIETARY_SUPPLEMENT

Bifidobacterium animalis A6

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

Intervention Type DIETARY_SUPPLEMENT

Cow milk

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

68 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Chinese Medicine Hospital-Pinggu Hospital

UNKNOWN

Sponsor Role collaborator

China Agricultural University

OTHER

Sponsor Role lead

Responsible Party

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Fazheng Ren

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beijing Chinese Medicine Hospital Pinggu Hospital

Beijing, , China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 5961288 (View on PubMed)

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.

Reference Type RESULT
PMID: 17098321 (View on PubMed)

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.

Reference Type RESULT
PMID: 5626114 (View on PubMed)

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.

Reference Type RESULT
PMID: 5806827 (View on PubMed)

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.

Reference Type RESULT
PMID: 5425915 (View on PubMed)

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

Reference Type RESULT
PMID: 5857053 (View on PubMed)

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.

Reference Type RESULT
PMID: 6365801 (View on PubMed)

Other Identifiers

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FDLT2DM-01

Identifier Type: -

Identifier Source: org_study_id

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