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Type 2 DiabetesPhase 1NCT04296825

Effect of Camel Milk With Probiotic on Type 2 Diabetes Mellitus

A Phase 1 study testing Camel milk containing Bifidobacterium animalis A6, Camel milk and Bifidobacterium animalis A6 in people with Type 2 Diabetes, run by China Agricultural University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 35 to 68 years
Conditions the study is for
Type 2 Diabetes
What is being tested?
Camel milk containing Bifidobacterium animalis A6, Camel milk and Bifidobacterium animalis A6
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
45 participants
Where
1 siteChina
Study dates
1 Jun 2018to 9 Jul 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 68 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Chinese Medicine Hospital Pinggu Hospital

    Beijing

Other trials in China

About this study

Official title: 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.

Conditions
Type 2 Diabetes
Being tested
Camel milk containing Bifidobacterium animalis A6, Camel milk, Bifidobacterium animalis A6, Cow milk
Keywords
Camel Milk, Probiotics, Gut Microbiome
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Camel milk containing Bifidobacterium animalis A6Dietary supplement

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

  • Camel milkDietary supplement

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

  • Bifidobacterium animalis A6Dietary supplement

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

  • Cow milkDietary supplement

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

Study groups in NCT04296825
Study groupRoleWhat they receive
PPlacebo comparatorPatients received cow milk for 4 consecutive weeks (two times per day, 10 gram each time).
Receives: Dietary Supplement: Cow milk
CAActive comparatorPatients 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).
Receives: Dietary Supplement: Camel milk containing Bifidobacterium animalis A6
CExperimentalPatients received camel milk for 4 consecutive weeks (two times per day, 10 gram each time).
Receives: Dietary Supplement: Camel milk
AExperimentalPatients received Bifidobacterium animalis A6 at a dose of 2×1010 viable cells for 4 consecutive weeks (two times per day, 10 gram each time).
Receives: Dietary Supplement: Bifidobacterium animalis A6

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 4 weeks

  2. 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

    Measured: 4 weeks

Secondary outcomes (6)

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

    follow up the patients at week 0, 4

    Measured: 4 weeks

  2. Changes in fecal microbiome

    follow up the patients at week 0, 4

    Measured: 4 weeks

  3. 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

    Measured: 4 weeks

  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

    Measured: 4 weeks

  5. 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

    Measured: 4 weeks

  6. Changes in gut hormones (amylin, ghrelin, GLP-1, PP and PYY in petagram per milliliter)

    follow up the patients at week 0, 4

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2020
  2. Study start1 Jun 2018
  3. Primary completion9 Jun 2018
  4. Study completion9 Jul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04296825
Sponsor's protocol ID
FDLT2DM-01
Status last verified
Jun 2018
First submitted
2 Mar 2020
Last updated
5 Mar 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 5961288

  • 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.

    PubMed 17098321

  • 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.

    PubMed 5626114

  • 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.

    PubMed 5806827

  • 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.

    PubMed 5425915

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

    PubMed 5857053

  • 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.

    PubMed 6365801

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Camel milk containing Bifidobacterium animalis A6, Camel milk and Bifidobacterium animalis A6 in people with Type 2 Diabetes, run by China Agricultural University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in fasting blood glucose and 2 hour postprandial blood glucose in millimole per liter and insulin in μU/mL (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04296825, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2020.

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