Type 2 Diabetes MellitusNCT03926806
Yoghurt Consumption, Body Weight Management and Glycemic Control of T2DM Patients
A study testing Plain yoghurt and Vitamin B yoghurt in people with Type 2 Diabetes Mellitus, run by Harokopio University.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Plain yoghurt and Vitamin B yoghurt
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- 25 Nov 2016to 29 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Plain yoghurt, Vitamin B yoghurt
- Keywords
- yoghurt, vitamins B, body weight, glycemic control
- Medical subject headings
- Diabetes Mellitus, Type 2, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plain yoghurtOther
Also called Conventional yoghurt
cups of 200 g yoghurt
Vitamin B yoghurtOther
cups of 200 g yoghurt
| Study group | Role | What they receive |
|---|---|---|
| Plain yoghurt | Active comparator | 2x200g plain yoghurt/day for 12 weeks Receives: Other: Plain yoghurt |
| Vitamin B yoghurt | Experimental | 2x200g yoghurt enriched with vitamins B for 12 weeks Receives: Other: Vitamin B yoghurt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight management
Change of body weight after dietary intervention
Measured: 12 weeks
Glycemic control
Change of fasting plasma glucose after dietary intervention
Measured: 12 weeks
Secondary outcomes (2)
Change of ghrelin response
Change of ghrelin after the 12 weeks dietary intervention
Measured: 12 weeks
Change of GLP-1 response
Change of GLP-1 after the 12 weeks dietary intervention
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2019
- Study start25 Nov 2016
- Primary completion8 Aug 2018
- Study completion29 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harokopio University
- Sponsor type
- University, hospital or other
- Collaborators
- National and Kapodistrian University of Athens
- Responsible party
- Principal investigator, Amalia Yanni, Harokopio University
- Investigators
- Amalia Yanni, Principal investigator, Harokopio UniversityNikolaos Tentolouris, Study chair, National and Kapodistrian University of AthensVaios Karathanos, Study director, Harokopio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03926806
- Sponsor's protocol ID
- 1354.18-11-16
- Status last verified
- Apr 2019
- First submitted
- 22 Apr 2019
- Last updated
- 26 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27332081Kaur 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.
PubMed 24484939El 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.
PubMed 23591152
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dietary Intervention With Dairy Products (Yoghurt) on Body Weight Management and Glycemic Control of T2DM Patients
- ClinicalTrials.gov ID
- NCT03926806
- Acronym / sponsor ID
- 1354.18-11-16
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- yoghurt, vitamins B, body weight, glycemic control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Harokopio UniversityUniversity, hospital or other
- Collaborators
- National and Kapodistrian University of Athens
- Study start
- 25 Nov 2016 (actual)
- Primary completion
- 8 Aug 2018 (actual)
- Study completion
- 29 Dec 2018 (actual)
- First posted
- 25 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Plain yoghurt | Active comparator | Other: Plain yoghurt2x200g plain yoghurt/day for 12 weeks |
| Vitamin B yoghurt | Experimental | Other: Vitamin B yoghurt2x200g yoghurt enriched with vitamins B for 12 weeks |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plain yoghurtAlso: Conventional yoghurtcups of 200 g yoghurt | Other | Plain yoghurt |
| Vitamin B yoghurtcups of 200 g yoghurt | Other | Vitamin B yoghurt |
Primary outcome
Body weight management
Time frame: 12 weeks
Change of body weight after dietary intervention
Glycemic control
Time frame: 12 weeks
Change of fasting plasma glucose after dietary intervention
2 secondary outcomes
Change of ghrelin response
Time frame: 12 weeks
Change of GLP-1 response
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2019.
- Background: PubMed 27332081Panahi 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.
- Background: PubMed 24484939Kaur 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.
- Background: PubMed 23591152El 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amalia Yanni principal investigator
Harokopio University
Nikolaos Tentolouris study chair
National and Kapodistrian University of Athens
Vaios Karathanos study director
Harokopio University
Questions about this trial
What is this clinical trial studying?
A study testing Plain yoghurt and Vitamin B yoghurt in people with Type 2 Diabetes Mellitus, run by Harokopio University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight management (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03926806, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2019.