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

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.

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Sponsors and Collaborators

Harokopio University

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

More Information

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.

• 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
• Last Update Posted: April 26, 2019
• Last Verified: April 2019

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

Keywords provided by Amalia Yanni, Harokopio University:

yoghurt; vitamins B; body weight; glycemic control

Additional relevant MeSH terms:

Diabetes Mellitus, Type 2; Body Weight; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Vitamins; Vitamin B Complex; Micronutrients; Nutrients; Growth Substances; Physiological Effects of Drugs