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Yoghurt Consumption, Body Weight Management and Glycemic Control of T2DM Patients

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Plain yoghurt
Vitamin B yoghurt
Sponsored by
Harokopio University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring yoghurt, vitamins B, body weight, glycemic control

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • BMI 27-36
  • HbA1C < 8.5%
  • Constant body weight and dietary habits for the last 3 months
  • Stable dose of oral medication for at least 3 months
  • Diagnosed with T2DM for more than 1 year

Exclusion Criteria:

  • History of cardiovascular, gastrointestinal, renal and endocrinological diseases
  • Treatment for weight reduction
  • Lactose intolerance
  • Allergies to milk and dairy products
  • Alcohol consumption (> 2 drinks per day)
  • Intake of supplements
  • Receiving insulin

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Plain yoghurt

    Vitamin B yoghurt

    Arm Description

    2x200g plain yoghurt/day for 12 weeks

    2x200g yoghurt enriched with vitamins B for 12 weeks

    Outcomes

    Primary Outcome Measures

    Body weight management
    Change of body weight after dietary intervention
    Glycemic control
    Change of fasting plasma glucose after dietary intervention

    Secondary Outcome Measures

    Change of ghrelin response
    Change of ghrelin after the 12 weeks dietary intervention
    Change of GLP-1 response
    Change of GLP-1 after the 12 weeks dietary intervention

    Full Information

    First Posted
    April 22, 2019
    Last Updated
    April 24, 2019
    Sponsor
    Harokopio University
    Collaborators
    National and Kapodistrian University of Athens
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03926806
    Brief Title
    Yoghurt Consumption, Body Weight Management and Glycemic Control of T2DM Patients
    Official Title
    Effect of Dietary Intervention With Dairy Products (Yoghurt) on Body Weight Management and Glycemic Control of T2DM Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    November 25, 2016 (Actual)
    Primary Completion Date
    August 8, 2018 (Actual)
    Study Completion Date
    December 29, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Harokopio University
    Collaborators
    National and Kapodistrian University of Athens

    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 study investigates the effects of consumption of yoghurt enriched with vitamins B compared to plain yoghurt, on body weight management and glycemic control of overweight/obese T2DM patients. It also investigates the effect of plain yoghurt consumption on gut hormones response of T2DM patients.
    Detailed Description
    In a large number of epidemiological studies, low-fat dairy consumption has been associated with lower risk of T2DM. However, the number of randomized clinical trials which examine the impact of yoghurt consumption on glycemic control and body weight management of T2DM patients is small and include yoghurts fortified with vitamin D or probiotics. According to our knowledge, fortification of yoghurt with other classes of vitamins beyond vitamin D has not been examined. Vitamins of B-complex hold key-role in energy metabolism. In the state of diabetes mellitus, the requirements for this vitamin class may be higher because of their water solubility and increased excretion. Two groups of patients participated in the study. One group received yoghurt enriched with vitamins B and one group received isocaloric plain yoghurt. In addition, in order to investigate the effect of plain yoghurt on gut hormones, responses to a mixed meal tolerance test were evaluated in the beggining and the end of the dietary intervention.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type 2 Diabetes Mellitus
    Keywords
    yoghurt, vitamins B, body weight, glycemic control

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Parallel assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    33 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Plain yoghurt
    Arm Type
    Active Comparator
    Arm Description
    2x200g plain yoghurt/day for 12 weeks
    Arm Title
    Vitamin B yoghurt
    Arm Type
    Experimental
    Arm Description
    2x200g yoghurt enriched with vitamins B for 12 weeks
    Intervention Type
    Other
    Intervention Name(s)
    Plain yoghurt
    Other Intervention Name(s)
    Conventional yoghurt
    Intervention Description
    cups of 200 g yoghurt
    Intervention Type
    Other
    Intervention Name(s)
    Vitamin B yoghurt
    Intervention Description
    cups of 200 g yoghurt
    Primary Outcome Measure Information:
    Title
    Body weight management
    Description
    Change of body weight after dietary intervention
    Time Frame
    12 weeks
    Title
    Glycemic control
    Description
    Change of fasting plasma glucose after dietary intervention
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Change of ghrelin response
    Description
    Change of ghrelin after the 12 weeks dietary intervention
    Time Frame
    12 weeks
    Title
    Change of GLP-1 response
    Description
    Change of GLP-1 after the 12 weeks dietary intervention
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: BMI 27-36 HbA1C < 8.5% Constant body weight and dietary habits for the last 3 months Stable dose of oral medication for at least 3 months Diagnosed with T2DM for more than 1 year Exclusion Criteria: History of cardiovascular, gastrointestinal, renal and endocrinological diseases Treatment for weight reduction Lactose intolerance Allergies to milk and dairy products Alcohol consumption (> 2 drinks per day) Intake of supplements Receiving insulin
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Amalia Yanni
    Organizational Affiliation
    Harokopio University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Nikolaos Tentolouris
    Organizational Affiliation
    National and Kapodistrian University of Athens
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Vaios Karathanos
    Organizational Affiliation
    Harokopio University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    27332081
    Citation
    Panahi S, Tremblay A. The Potential Role of Yogurt in Weight Management and Prevention of Type 2 Diabetes. J Am Coll Nutr. 2016 Nov-Dec;35(8):717-731. doi: 10.1080/07315724.2015.1102103. Epub 2016 Jun 22.
    Results Reference
    background
    PubMed Identifier
    24484939
    Citation
    Kaur B, Henry J. Micronutrient status in type 2 diabetes: a review. Adv Food Nutr Res. 2014;71:55-100. doi: 10.1016/B978-0-12-800270-4.00002-X.
    Results Reference
    background
    PubMed Identifier
    23591152
    Citation
    El Khoury D, Brown P, Smith G, Berengut S, Panahi S, Kubant R, Anderson GH. Increasing the protein to carbohydrate ratio in yogurts consumed as a snack reduces post-consumption glycemia independent of insulin. Clin Nutr. 2014 Feb;33(1):29-38. doi: 10.1016/j.clnu.2013.03.010. Epub 2013 Mar 27.
    Results Reference
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    Yoghurt Consumption, Body Weight Management and Glycemic Control of T2DM Patients

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