Clinical trial NCT03926806: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: yoghurt
vitamins B
body weight
glycemic control
Lead sponsor: Harokopio University
Sponsor class: OTHER
Collaborators: name: National and Kapodistrian University of Athens
First posted: 2019-04-25
Enrollment: 33
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Body weight management
timeFrame: 12 weeks
measure: Glycemic control
timeFrame: 12 weeks
Secondary outcomes:
measure: Change of ghrelin response
timeFrame: 12 weeks
measure: Change of GLP-1 response
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Harokopio University
name: Amalia Yanni
role: PRINCIPAL_INVESTIGATOR
affiliation: National and Kapodistrian University of Athens
name: Nikolaos Tentolouris
role: STUDY_CHAIR
affiliation: Harokopio University
name: Vaios Karathanos
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1080/07315724.2015.1102103. Epub 2016 Jun 22.
citation: 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.
citation: 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.