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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

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

Clinicaltrials.gov identifier NCT03926806

Recruitment Status Completed

First Posted April 25, 2019

Last update posted April 26, 2019

Study Description

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.

  • Condition or Disease:Type 2 Diabetes Mellitus
  • Intervention/Treatment: Other: Plain yoghurt
    Other: Vitamin B yoghurt
  • Phase: N/A
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
  • Actual Enrollment: 33 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Intervention Model Description: Parallel assignment
  • Masking: Double (Participant, Care Provider)
  • Primary Purpose: Treatment
  • Official Title: Effect of Dietary Intervention With Dairy Products (Yoghurt) on Body Weight Management and Glycemic Control of T2DM Patients
  • Actual Study Start Date: November 2016
  • Actual Primary Completion Date: August 2018
  • Actual Study Completion Date: December 2018
Arms and interventions
Arm Intervention/treatment
Active Comparator: Plain yoghurt
2x200g plain yoghurt/day for 12 weeks
Other: Plain yoghurt
cups of 200 g yoghurt
Experimental: Vitamin B yoghurt
2x200g yoghurt enriched with vitamins B for 12 weeks
Other: Vitamin B yoghurt
cups of 200 g yoghurt
Outcome Measures
  • Primary Outcome Measures: 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 Outcome Measures: 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
Eligibility Criteria
  • Ages Eligible for Study: 45 to 75 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- BMI 27-36

- HbA1C 2 drinks per day)

- Intake of supplements

- Receiving insulin

Contacts and Locations
Contacts
Locations
Sponsors and Collaborators

Harokopio University

National and Kapodistrian University of Athens

Investigators

Principal Investigator: Amalia Yanni Harokopio University

Study Chair: Nikolaos Tentolouris National and Kapodistrian University of Athens

Study Director: Vaios Karathanos Harokopio University

More Information