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

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. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Other: Plain yoghurt Other: Vitamin B yoghurt Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Effect of Dietary Intervention With Dairy Products (Yoghurt) on Body Weight Management and Glycemic Control of T2DM Patients
Actual Study Start Date : November 25, 2016
Actual Primary Completion Date : August 8, 2018
Actual Study Completion Date : December 29, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Plain yoghurt
2x200g plain yoghurt/day for 12 weeks
Other: Plain yoghurt
cups of 200 g yoghurt
Other Name: Conventional yoghurt

Experimental: Vitamin B yoghurt
2x200g yoghurt enriched with vitamins B for 12 weeks
Other: Vitamin B yoghurt
cups of 200 g yoghurt




Primary Outcome Measures :
  1. Body weight management [ Time Frame: 12 weeks ]
    Change of body weight after dietary intervention

  2. Glycemic control [ Time Frame: 12 weeks ]
    Change of fasting plasma glucose after dietary intervention


Secondary Outcome Measures :
  1. Change of ghrelin response [ Time Frame: 12 weeks ]
    Change of ghrelin after the 12 weeks dietary intervention

  2. Change of GLP-1 response [ Time Frame: 12 weeks ]
    Change of GLP-1 after the 12 weeks dietary intervention



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT03926806


Sponsors and Collaborators
Harokopio University
National and Kapodistrian University of Athens
Investigators
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Principal Investigator: Amalia Yanni Harokopio University
Study Chair: Nikolaos Tentolouris National and Kapodistrian University of Athens
Study Director: Vaios Karathanos Harokopio University
Publications:
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Responsible Party: Amalia Yanni, Research and Teaching Associate-Staff, Harokopio University
ClinicalTrials.gov Identifier: NCT03926806    
Other Study ID Numbers: 1354.18-11-16
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amalia Yanni, Harokopio University:
yoghurt
vitamins B
body weight
glycemic control
Additional relevant MeSH terms:
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Body Weight
Vitamins
Vitamin B Complex
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs