Skip to main content
OpenTrials
Completed

NCT Number: NCT04296825

Effect of Camel Milk With Probiotic on 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

35 year–68 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beijing Chinese Medicine Hospital Pinggu Hospital

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Camel milk

Dietary Supplement

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

Bifidobacterium animalis A6

Dietary Supplement

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

Cow milk

Dietary Supplement

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

Primary outcomes

  1. Changes in fasting blood glucose and 2 hour postprandial blood glucose in millimole per liter and insulin in μU/mL

    Time frame: 4 weeks

    follow up the patients at week 0, 4

  2. Changes in lipid profiles (total cholesterol, total triglyceride, high-density lipoprotein cholesterol and low-density lipoprotein cholesterol in millimole per liter)

    Time frame: 4 weeks

    follow up the patients at week 0, 4

Secondary outcomes

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

    Time frame: 4 weeks

    follow up the patients at week 0, 4

  2. Changes in fecal microbiome

    Time frame: 4 weeks

    follow up the patients at week 0, 4

  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.

    Time frame: 4 weeks

    follow up the patients at week 0, 4

  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). )

    Time frame: 4 weeks

    follow up the patients at week 0, 4

  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)

    Time frame: 4 weeks

    follow up the patients at week 0, 4

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

    Time frame: 4 weeks

    follow up the patients at week 0, 4

Sponsors and collaborators

Lead sponsor

China Agricultural University

Other

Collaborators

  • Beijing Chinese Medicine Hospital-Pinggu Hospital

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 5, 2020
Registry last updated
Mar 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.