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

Harokopio University

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Other: Plain yoghurt; Other: Vitamin B yoghurt

Study type: Interventional

Funder types: Other

Identifiers

NCT03926806

1354.18-11-16

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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33 participants in 2 patient groups

Plain yoghurt

Active Comparator group

Description:

2x200g plain yoghurt/day for 12 weeks

Treatment:

Other: Plain yoghurt

Vitamin B yoghurt

Experimental group

Description:

2x200g yoghurt enriched with vitamins B for 12 weeks

Treatment:

Other: Vitamin B yoghurt