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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03926806
• Other study ID #: 1354.18-11-16
• Status: Completed
• Phase: N/A
• Start date: November 25, 2016
• Est. completion date: December 29, 2018

Study information

• Verified date: April 2019
• Source: Harokopio University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 29, 2018
• Est. primary completion date: August 8, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Harokopio University	National and Kapodistrian University of Athens

References & Publications (3)

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. — View 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. Review. — View 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. Epub 2016 Jun 22. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight management	Change of body weight after dietary intervention	12 weeks
Primary	Glycemic control	Change of fasting plasma glucose after dietary intervention	12 weeks
Secondary	Change of ghrelin response	Change of ghrelin after the 12 weeks dietary intervention	12 weeks
Secondary	Change of GLP-1 response	Change of GLP-1 after the 12 weeks dietary intervention	12 weeks