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

Not Applicable
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
Other: Plain yoghurt
Other: Vitamin B yoghurt
Registration Number
NCT03926806
Lead Sponsor
Harokopio University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
33
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Plain yoghurtPlain yoghurt2x200g plain yoghurt/day for 12 weeks
Vitamin B yoghurtVitamin B yoghurt2x200g yoghurt enriched with vitamins B for 12 weeks
Primary Outcome Measures
NameTimeMethod
Glycemic control12 weeks

Change of fasting plasma glucose after dietary intervention

Body weight management12 weeks

Change of body weight after dietary intervention

Secondary Outcome Measures
NameTimeMethod
Change of GLP-1 response12 weeks

Change of GLP-1 after the 12 weeks dietary intervention

Change of ghrelin response12 weeks

Change of ghrelin after the 12 weeks dietary intervention

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