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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-25

Study Completion Date

2018-12-29

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel assignment

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Plain yoghurt

2x200g plain yoghurt/day for 12 weeks

Group Type ACTIVE_COMPARATOR

Plain yoghurt

Intervention Type OTHER

cups of 200 g yoghurt

Vitamin B yoghurt

2x200g yoghurt enriched with vitamins B for 12 weeks

Group Type EXPERIMENTAL

Vitamin B yoghurt

Intervention Type OTHER

cups of 200 g yoghurt

Interventions

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Plain yoghurt

cups of 200 g yoghurt

Intervention Type OTHER

Vitamin B yoghurt

cups of 200 g yoghurt

Intervention Type OTHER

Other Intervention Names

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Conventional yoghurt

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No