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Effect of Camel Milk With Probiotic on Type 2 Diabetes Mellitus

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Camel milk containing Bifidobacterium animalis A6
Camel milk
Bifidobacterium animalis A6
Cow milk
Sponsored by
China Agricultural University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 2 Diabetes focused on measuring Camel Milk, Probiotics, Gut Microbiome

Eligibility Criteria

35 Years - 68 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beijing Chinese Medicine Hospital Pinggu Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Experimental

Experimental

Arm Label

P

CA

C

A

Arm Description

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

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).

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

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).

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Changes in inflammation cytokines ( TNF-α, IL-6 and MCP-1 in petagram per milliliter)
follow up the patients at week 0, 4
Changes in fecal microbiome
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.
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). )
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)
follow up the patients at week 0, 4
Changes in gut hormones (amylin, ghrelin, GLP-1, PP and PYY in petagram per milliliter)
follow up the patients at week 0, 4

Full Information

First Posted
March 2, 2020
Last Updated
March 3, 2020
Sponsor
China Agricultural University
Collaborators
Beijing Chinese Medicine Hospital-Pinggu Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04296825
Brief Title
Effect of Camel Milk With Probiotic on Type 2 Diabetes Mellitus
Official Title
Effect of Camel Milk Containing Bifidobacterium Animalis A6 on Chinese People With Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
June 9, 2018 (Actual)
Study Completion Date
July 9, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Agricultural University
Collaborators
Beijing Chinese Medicine Hospital-Pinggu Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Camel Milk, Probiotics, Gut Microbiome

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
P
Arm Type
Placebo Comparator
Arm Description
Patients received cow milk for 4 consecutive weeks (two times per day, 10 gram each time).
Arm Title
CA
Arm Type
Active Comparator
Arm Description
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).
Arm Title
C
Arm Type
Experimental
Arm Description
Patients received camel milk for 4 consecutive weeks (two times per day, 10 gram each time).
Arm Title
A
Arm Type
Experimental
Arm Description
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).
Intervention Type
Dietary Supplement
Intervention Name(s)
Camel milk containing Bifidobacterium animalis A6
Intervention Description
Take the interventions about 30 minutes after meals in the morning and evening for 4 consecutive weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Camel milk
Intervention Description
Take the interventions about 30 minutes after meals in the morning and evening for 4 consecutive weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Bifidobacterium animalis A6
Intervention Description
Take the interventions about 30 minutes after meals in the morning and evening for 4 consecutive weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Cow milk
Intervention Description
Take the interventions about 30 minutes after meals in the morning and evening for 4 consecutive weeks.
Primary Outcome Measure Information:
Title
Changes in fasting blood glucose and 2 hour postprandial blood glucose in millimole per liter and insulin in μU/mL
Description
follow up the patients at week 0, 4
Time Frame
4 weeks
Title
Changes in lipid profiles (total cholesterol, total triglyceride, high-density lipoprotein cholesterol and low-density lipoprotein cholesterol in millimole per liter)
Description
follow up the patients at week 0, 4
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Changes in inflammation cytokines ( TNF-α, IL-6 and MCP-1 in petagram per milliliter)
Description
follow up the patients at week 0, 4
Time Frame
4 weeks
Title
Changes in fecal microbiome
Description
follow up the patients at week 0, 4
Time Frame
4 weeks
Title
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.
Description
follow up the patients at week 0, 4
Time Frame
4 weeks
Title
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). )
Description
follow up the patients at week 0, 4
Time Frame
4 weeks
Title
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)
Description
follow up the patients at week 0, 4
Time Frame
4 weeks
Title
Changes in gut hormones (amylin, ghrelin, GLP-1, PP and PYY in petagram per milliliter)
Description
follow up the patients at week 0, 4
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
68 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Beijing Chinese Medicine Hospital Pinggu Hospital
City
Beijing
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
5961288
Citation
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Results Reference
background
PubMed Identifier
17098321
Citation
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.
Results Reference
result
PubMed Identifier
5626114
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. No abstract available. Japanese.
Results Reference
result
PubMed Identifier
5806827
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. No abstract available. Italian.
Results Reference
result
PubMed Identifier
5425915
Citation
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.
Results Reference
result
PubMed Identifier
5857053
Citation
Burdon JF. [Medicine in Great Britain]. Concours Med. 1965 Oct 9;87(41):5799-803. No abstract available. French.
Results Reference
result
PubMed Identifier
6365801
Citation
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.
Results Reference
result

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Effect of Camel Milk With Probiotic on Type 2 Diabetes Mellitus

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