NCT03926806

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable type-2-diabetes-mellitus

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 25, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 25, 2019

Completed
Last Updated

April 26, 2019

Status Verified

April 1, 2019

Enrollment Period

1.7 years

First QC Date

April 22, 2019

Last Update Submit

April 24, 2019

Conditions

Type 2 Diabetes Mellitus

Keywords

yoghurtvitamins Bbody weightglycemic control

Outcome Measures

Primary Outcomes (2)

  • Body weight management

    Change of body weight after dietary intervention

    12 weeks

  • Glycemic control

    Change of fasting plasma glucose after dietary intervention

    12 weeks

Secondary Outcomes (2)

  • Change of ghrelin response

    12 weeks

  • Change of GLP-1 response

    12 weeks

Study Arms (2)

Plain yoghurt

ACTIVE COMPARATOR

2x200g plain yoghurt/day for 12 weeks

Other: Plain yoghurt

Vitamin B yoghurt

EXPERIMENTAL

2x200g yoghurt enriched with vitamins B for 12 weeks

Other: Vitamin B yoghurt

Interventions

Plain yoghurtOTHER

cups of 200 g yoghurt

Also known as: Conventional yoghurt
Plain yoghurt
Vitamin B yoghurtOTHER

cups of 200 g yoghurt

Vitamin B yoghurt

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Panahi S, Tremblay A. The Potential Role of Yogurt in Weight Management and Prevention of Type 2 Diabetes. J Am Coll Nutr. 2016 Nov-Dec;35(8):717-731. doi: 10.1080/07315724.2015.1102103. Epub 2016 Jun 22.

    PMID: 27332081BACKGROUND

  • Kaur B, Henry J. Micronutrient status in type 2 diabetes: a review. Adv Food Nutr Res. 2014;71:55-100. doi: 10.1016/B978-0-12-800270-4.00002-X.

    PMID: 24484939BACKGROUND

  • El Khoury D, Brown P, Smith G, Berengut S, Panahi S, Kubant R, Anderson GH. Increasing the protein to carbohydrate ratio in yogurts consumed as a snack reduces post-consumption glycemia independent of insulin. Clin Nutr. 2014 Feb;33(1):29-38. doi: 10.1016/j.clnu.2013.03.010. Epub 2013 Mar 27.

    PMID: 23591152BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Body Weight

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Amalia Yanni

    Harokopio University

    PRINCIPAL INVESTIGATOR

  • Nikolaos Tentolouris

    National and Kapodistrian University of Athens

    STUDY CHAIR

  • Vaios Karathanos

    Harokopio University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research and Teaching Associate-Staff

Study Record Dates

First Submitted

April 22, 2019

First Posted

April 25, 2019

Study Start

November 25, 2016

Primary Completion

August 8, 2018

Study Completion

December 29, 2018

Last Updated

April 26, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share