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

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

Tracking Information

• First Submitted Date: April 22, 2019
• First Posted Date: April 25, 2019
• Last Update Posted Date: April 26, 2019
• Actual Study Start Date: November 25, 2016
• Actual Primary Completion Date: August 8, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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

Current Secondary Outcome Measures (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 (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: 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
• 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: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Parallel assignment

Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment

• Condition: Type 2 Diabetes Mellitus

Intervention

• Other: Plain yoghurt
  cups of 200 g yoghurt
  Other Name: Conventional yoghurt
• Other: Vitamin B yoghurt
  cups of 200 g yoghurt

Study Arms

• 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 *

• 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. Epub 2016 Jun 22. Review.
• 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. Review.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 22, 2019): 33
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: December 29, 2018
• Actual Primary Completion Date: August 8, 2018 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 45 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT03926806
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: Amalia Yanni, Harokopio University
• Study Sponsor: Harokopio University
• Collaborators: National and Kapodistrian University of Athens

Investigators

• 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