ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 5 for:    7782892 [PUBMED-IDS]
Previous Study | Return to List | Next Study

Commercial Prebiotic Supplement Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03141710
Recruitment Status : Recruiting
First Posted : May 5, 2017
Last Update Posted : October 25, 2017
Sponsor:
Information provided by (Responsible Party):
University of Aberdeen

Brief Summary:

Previous work in 2015/16 has identified changes in the gut microbiota with prebiotic (Molkosan®) supplement. It report significant changes in metabolic health bio-markers and faecal SCFA profile in 18 health adult subjects consuming 20 ml of product twice a day. Improvement in fasting metabolic parameters was observed flowing the intervention period. A reduction on Total Cholesterol, Glucose, Triglycerides and Insulin was observed.

In this study, a lower dose (20ml/d) in subjects with type 2 diabetes will be examed, over an extended period of time (12 week period) to match the profile of the intended consumer and provide preliminary data to support a larger multi-centre trial.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Dietary Supplement: 20 ml of prebiotic per day Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Intervention Model Description: 20ml of prebiotic per day for 12 weeks
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effect of Prebiotic in Type 2 Diabetes (Diabetes and Health Study)
Actual Study Start Date : May 10, 2017
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 12 type 2 diabetes patients
Long-term dietary (12 weeks) intervention of 20ml of prebiotic per day
Dietary Supplement: 20 ml of prebiotic per day
12 volunteers will take 20ml of prebiotic per day for 12 weeks




Primary Outcome Measures :
  1. Change of oral glucose tolerance test (OGTT) [ Time Frame: At baseline and 12 weeks prebiotic consumption ]
    Six blood samples will be collected during the course of 3 hours (0, 30, 60, 90,120 and 180 min) using a cannulation after consuming 75 g of Polycal liquid (glucose load). Plasma glucose level will be measured by KONI analysis and


Secondary Outcome Measures :
  1. Change of insulin levels [ Time Frame: At baseline, 6 weeks and 12 weeks prebiotic consumption ]
    Six blood samples will be collected during the course of 3 hours (0, 30, 60, 90,120 and 180 min) using a cannulation after consuming 75 g of Polycal liquid (glucose load). insulin level will be measured by luminex assay.

  2. HbA1c measured by Alere Afinion™ AS100 Analyzer [ Time Frame: At baseline and 12 weeks prebiotic consumption ]

    The term HbA1c refers to glycated haemoglobin. It develops when haemoglobin, a protein within red blood cells that carries oxygen throughout the body. By measuring glycated haemoglobin (HbA1c) can indicate blood sugar levels.

    Finger prick method will be introduced to collect the small amount of blood samples into the Alere Afinion™ AS100 Analyzer cartridge. Insert cartridge to the machine to read the data. Inclusion criteria will be the levels above 6 % (42mmol/mol). We will also measure HbA1c at 12 week to monitor for changes.


  3. Change of BMI (kg/m^2) measurement [ Time Frame: At baseline and 12 weeks prebiotic consumption ]
    Weight or Body Mass is defined as the quantity of matter in the body, measured by weight (kg) i.e. the force that matter exerts under standard gravitational effect. Height (m) will be recorded for conjunction with weight measurements to calculate Body Mass Index (BMI) values.

  4. Change of Total Cholesterol levels [ Time Frame: At baseline, 6 weeks and 12 weeks prebiotic consumption ]
    Total cholesterol (HDL and LDL -Cholesterols) will be measured by KONI analysis at University of Aberdeen. Separately measured HDL- and LDL-cholesterols levels will be combined for total cholesterol levels.

  5. Change of GLP-1 levels [ Time Frame: At baseline, 6 weeks and 12 weeks prebiotic consumption ]
    The incretin hormones, glucagon-like peptide-1 (GLP-1) secretion, contributes to glucose intolerance. GLP-1 levels will be measured by luminex assay.

  6. Change of GIP levels [ Time Frame: At baseline, 6 weeks and 12 weeks prebiotic consumption ]
    Glucose-dependent insulinotropic polypeptide (GIP) is potentiate the insulin response to nutrients. Insulinotropic capacity of GIP is markedly diminished in type 2 diabetes. Incretin hormone GIP will be measured by luminex assay.

  7. Change of triglyceride levels [ Time Frame: At baseline, 6 weeks and 12 weeks prebiotic consumption ]
    Triglyceride levels will be measured for identifying the lipid profiles. Triglyceride will be measured by KONI analysis.

  8. Change of C-peptide levels [ Time Frame: At baseline, 6 weeks and 12 weeks prebiotic consumption ]
    C-peptide are involved to hepatic insulin extraction. C-peptide levels are measured by luminex assay.

  9. Change of glucagon levels [ Time Frame: At baseline, 6 weeks and 12 weeks prebiotic consumption ]
    Glucagon levels will be measured by luminex assay.

  10. Change of fermentation markers [ Time Frame: At baseline and 12 weeks prebiotic consumption ]
    Breath samples will be measured hydrogen and methane levels



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Impaired glucose tolerance (IGT, identified by HbA1c) or type 2 diabetes (lifestyle management; identified by HbA1c) age 18-65, with BMI 18-40 kg m-2, measured at screening visit.

Exclusion Criteria:

  • Type 1 Diabetes, Severe gastrointestinal disorders (IBD), Kidney disease, Thromboembolic or coagulation disease, Hepatic disease, Alcohol or any other substance abuse, Eating disorders, Unregulated thyroid disease, Antibiotic use within the last 3 months, including proscribed and prescribed use. Current probiotic use or prebiotic use. Medication for glucose regulation. Female with breast feeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03141710


Contacts
Contact: Alexandra M Johnstone, PhD 00441224438614 alex.johnstone@abdn.ac.uk
Contact: Karen Scott, PhD 00441224438730

Locations
United Kingdom
The Rowett Institute, Human Nutrition Unit Recruiting
Aberdeen, United Kingdom, AB25 2ZD
Contact: Alexandra M Johnstone, PhD    00441224438614    alex.johnstone@abdn.ac.uk   
Sponsors and Collaborators
University of Aberdeen
Investigators
Principal Investigator: Alexandra M Johnstone, PhD University of Aberdeen, The Rowett Institute

Publications:

Responsible Party: University of Aberdeen
ClinicalTrials.gov Identifier: NCT03141710     History of Changes
Other Study ID Numbers: Study 805
First Posted: May 5, 2017    Key Record Dates
Last Update Posted: October 25, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases