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

April 24, 2019 updated by: Amalia Yanni, Harokopio University

Effect of Dietary Intervention With Dairy Products (Yoghurt) on 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Plain yoghurt
2x200g plain yoghurt/day for 12 weeks
Other: Plain yoghurt
cups of 200 g yoghurt
Other Names:
  • Conventional yoghurt
Experimental: Vitamin B yoghurt
2x200g yoghurt enriched with vitamins B for 12 weeks
Other: Vitamin B yoghurt
cups of 200 g yoghurt

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body weight management
Time Frame: 12 weeks
Change of body weight after dietary intervention
12 weeks
Glycemic control
Time Frame: 12 weeks
Change of fasting plasma glucose after dietary intervention
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of ghrelin response
Time Frame: 12 weeks
Change of ghrelin after the 12 weeks dietary intervention
12 weeks
Change of GLP-1 response
Time Frame: 12 weeks
Change of GLP-1 after the 12 weeks dietary intervention
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harokopio University

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 25, 2016

Primary Completion (Actual)

August 8, 2018

Study Completion (Actual)

December 29, 2018

Study Registration Dates

First Submitted

April 22, 2019

First Submitted That Met QC Criteria

April 22, 2019

First Posted (Actual)

April 25, 2019

Study Record Updates

Last Update Posted (Actual)

April 26, 2019

Last Update Submitted That Met QC Criteria

April 24, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1354.18-11-16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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