Effect of Dietary Intervention With Dairy Products (Yoghurt) on Body Weight Management and Glycemic Control of T2DM Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Harokopio University
- Enrollment
- 33
- Primary Endpoint
- Glycemic control
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 45 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Plain yoghurt
2x200g plain yoghurt/day for 12 weeks
Intervention: Plain yoghurt (Other)
Vitamin B yoghurt
2x200g yoghurt enriched with vitamins B for 12 weeks
Intervention: Vitamin B yoghurt (Other)
Outcomes
Primary Outcomes
Glycemic control
Time Frame: 12 weeks
Change of fasting plasma glucose after dietary intervention
Body weight management
Time Frame: 12 weeks
Change of body weight after dietary intervention
Secondary Outcomes
- Change of GLP-1 response(12 weeks)
- Change of ghrelin response(12 weeks)
Investigators
Amalia Yanni
Research and Teaching Associate-Staff
Harokopio University