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Completed

NCT Number: NCT03926806

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

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Plain yoghurt

Other

cups of 200 g yoghurt

Other names: Conventional yoghurt

Vitamin B yoghurt

Other

cups of 200 g yoghurt

Primary outcomes

  1. Body weight management

    Time frame: 12 weeks

    Change of body weight after dietary intervention

  2. Glycemic control

    Time frame: 12 weeks

    Change of fasting plasma glucose after dietary intervention

Secondary outcomes

  1. Change of ghrelin response

    Time frame: 12 weeks

    Change of ghrelin after the 12 weeks dietary intervention

  2. Change of GLP-1 response

    Time frame: 12 weeks

    Change of GLP-1 after the 12 weeks dietary intervention

Sponsors and collaborators

Lead sponsor

Harokopio University

Other

Collaborators

  • National and Kapodistrian University of Athens

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 25, 2019
Registry last updated
Apr 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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