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

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ClinicalTrials.gov Identifier: NCT03926806
Recruitment Status : Completed
First Posted : April 25, 2019
Last Update Posted : April 26, 2019
Sponsor:
Collaborator:
National and Kapodistrian University of Athens
Information provided by (Responsible Party):
Amalia Yanni, Harokopio University

Tracking Information
First Submitted Date  ICMJE April 22, 2019
First Posted Date  ICMJE April 25, 2019
Last Update Posted Date April 26, 2019
Actual Study Start Date  ICMJE November 25, 2016
Actual Primary Completion Date August 8, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2019)
  • Body weight management [ Time Frame: 12 weeks ]
    Change of body weight after dietary intervention
  • Glycemic control [ Time Frame: 12 weeks ]
    Change of fasting plasma glucose after dietary intervention
Original Primary Outcome Measures  ICMJE
 (submitted: April 22, 2019)
  • Body weight management [ Time Frame: 12 weeks ]
    Reduction of body weight after dietary intervention
  • Glycemic control [ Time Frame: 12 weeks ]
    Reduction of HbA1C
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2019)
  • Change of ghrelin response [ Time Frame: 12 weeks ]
    Change of ghrelin after the 12 weeks dietary intervention
  • Change of GLP-1 response [ Time Frame: 12 weeks ]
    Change of GLP-1 after the 12 weeks dietary intervention
Original Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2019)
  • Improvement of ghrelin response [ Time Frame: 12 weeks ]
    Ghrelin suppression after the 12 weeks dietary intervention
  • Improvement of GLP-1 response [ Time Frame: 12 weeks ]
    Increment of GLP-1 after the 12 weeks dietary intervention
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Yoghurt Consumption, Body Weight Management and Glycemic Control of T2DM Patients
Official Title  ICMJE Effect of Dietary Intervention With Dairy Products (Yoghurt) on Body Weight Management and Glycemic Control of T2DM Patients
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Parallel assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • Other: Plain yoghurt
    cups of 200 g yoghurt
    Other Name: Conventional yoghurt
  • Other: Vitamin B yoghurt
    cups of 200 g yoghurt
Study Arms  ICMJE
  • Active Comparator: Plain yoghurt
    2x200g plain yoghurt/day for 12 weeks
    Intervention: Other: Plain yoghurt
  • Experimental: Vitamin B yoghurt
    2x200g yoghurt enriched with vitamins B for 12 weeks
    Intervention: Other: Vitamin B yoghurt
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 22, 2019)
33
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 29, 2018
Actual Primary Completion Date August 8, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03926806
Other Study ID Numbers  ICMJE 1354.18-11-16
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Amalia Yanni, Harokopio University
Study Sponsor  ICMJE Harokopio University
Collaborators  ICMJE National and Kapodistrian University of Athens
Investigators  ICMJE
Principal Investigator: Amalia Yanni Harokopio University
Study Chair: Nikolaos Tentolouris National and Kapodistrian University of Athens
Study Director: Vaios Karathanos Harokopio University
PRS Account Harokopio University
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP