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

Study Overview
=================
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.

Official Title
-----------------
Effect of Dietary Intervention With Dairy Products (Yoghurt) on Body Weight Management and Glycemic Control of T2DM Patients

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Other: Plain yoghurt
* Other: Vitamin B yoghurt


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Plain yoghurt<br>2x200g plain yoghurt/day for 12 weeks | Other: Plain yoghurt<br>* cups of 200 g yoghurt<br>* Other names: Conventional yoghurt;|
| Experimental: Vitamin B yoghurt<br>2x200g yoghurt enriched with vitamins B for 12 weeks | Other: Vitamin B yoghurt<br>* cups of 200 g yoghurt<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight management | Change of body weight after dietary intervention | 12 weeks | 
| Glycemic control | Change of fasting plasma glucose after dietary intervention | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of ghrelin response | Change of ghrelin after the 12 weeks dietary intervention | 12 weeks | 
| Change of GLP-1 response | Change of GLP-1 after the 12 weeks dietary intervention | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
yoghurt, vitamins B, body weight, glycemic control