Diabetes Mellitus, Type 2ODANCT05887544
Towards Objective Dietary Assessment in Large-scale Studies
An observational study of Diabetes Mellitus, Type 2, run by University of Copenhagen at 1 site in Denmark.
Trial summary
Enabling an objective measure of diet, covering individual foods as well as different dietary patterns, in large-scale studies has great potential; this would for instance improve our understanding of the role of diet in long-term disease prevention and care in people with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Exposure: Plant-based diet pattern, Intervention: Fermented dairy products and Exposure: individual foods and food groups
- How many people
- 4 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jun 2023to 19 Mar 2024
- Phase
- Observational
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults with newly diagnosed type 2 diabetes that are otherwise generally health and willing to participate in the study.
Who may be able to join
- Newly diagnosed type 2 diabetes (within the last 5 years from study start) (self-reported)
- 18.5-35.0 kg/m2 BMI
- More than 1cm of natural hair on the head
- Have not dyed their hair in the previous 6 months
- Willing to record dietary intake up to 9 days
- Willing to have blood samples drawn two times
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- Willing to collect up to two 24-hour urine samples and 7 spot urine samples at home and be able to store them in their own freezer in provided tubes and boxes throughout the one-month study
- Have no intention to radically change dietary and physical activity habits during the study period
- Owning a smartphone with internet connection
- Can speak and read Danish
Who cannot join
- Pregnant or lactating women
- Diagnosed with any chronic or communicable diseases including liver diseases (e.g., active hepatitis B and C infections), liver cirrhosis, severe psychiatric illness or any other clinical condition that makes the subject ineligible according to the clinically responsible medical doctor (except type 2 diabetes) (self-reported).
- History of cancer within the past 5 years (except adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer)
- Diagnosed with any CVD event (e.g., myocardial infarction, revascularization procedure or stroke) within the past 2 years
- Unintentional weight loss >20% during the last 6 months
- Regular intake of prescription medication (except diabetes medication, blood pressure-lowering medication, cholesterol-lowering medication, mild antidepressants or contraceptive pills)
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- Concurrent participation in another trial
- Not willing to sign the Informed consent form (ICF)
- Not willing to comply with the all the trial procedures
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Nutrition, Exercise and Sports, University of Copenhagen
Copenhagen, Frederiksberg C, 1958
About this study
Enabling an objective measure of diet, covering individual foods as well as different dietary patterns, in large-scale studies has great potential; this would for instance improve our understanding of the role of diet in long-term disease prevention and care in people with type 2 diabetes.
The overarching aim of this study is to develop a framework from which dietary intake can be assessed, both as single foods and dietary patterns, in cohort studies among people with type 2 diabetes. This study is performed to assess which collection strategy best reflects long-term dietary intake and to weigh this up against feasibility and costs in large-scale studies.
Read the detailed description
This is a 4-week observational study that will be carried out in adults with newly diagnosed type 2 diabetes living in Denmark.
The aim is to recruit up to 60 participants aged 18-75. The participants will be asked to record and weight their habitual food intake on 8 days spread out within a one-month time period. They will also be asked to complete one 24-hour urine collection the day before study start and provide 7 morning spot urine samples on the subsequent mornings after filling in the food diary.
At the start of the study period participants will undergo a DXA scan and have a blood sample taken. At the end of the study period a second blood sample will be drawn and a hair sample will also be collected. Incomplete 24-hour collections will be judged based on predicted 24-hour creatinine excretion from lean body mass and actual creatinine excretion being in the interval from 0.8-1.2, which corresponds to ~20% on each side of the expected excretion. Participants falling outside this interval will be asked to complete a new 24-hour urine sample. As the primary aim of this study is validation, it is important that the samples provided are as complete as possible.
In the one-month period between visits to the study center, a subset of volunteer participants (up to 20 participants) will be asked to consume extra portions of fermented dairy products (skyr, ymer and yogurt) 1-2 days before the spot urine sample to be able to validate markers for specific foods. All participants in the subcohort will consume each of the foods one time before a spot urine and one time be asked to abstain intake of dairy products as a control. Foods will be provided to the participants.
Note: the study has ended with fewer participants than expected due to problems with recruitment. We will analyse these samples and work on samples from another study to answer our initial research questions.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Exposure: Plant-based diet pattern, Intervention: Fermented dairy products, Exposure: individual foods and food groups
- Keywords
- sampling, food intake biomarkers, type 2 diabetes, urine, blood, hair, diet assessment
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure: Plant-based diet patternOther
Also called Plant-based diet index
From dietary records average intake across food groups will be calculated and a plant-based diet index score will be generated to group participants.
Intervention: Fermented dairy productsOther
Also called Commercially available skyr, ymer and yogurt
1000g of the product to be consumed 1-2 days prior to spot urine sample.
Exposure: individual foods and food groupsOther
Also called Foods and food groups
From the dietary records, average intake of specific foods or food groups will be calcualted.
| Study group | Role | What they receive |
|---|---|---|
| Type 2 diabetes | Overall study population. In addition, a subset of volunteer participants (up to 20 participants) will be asked to consume extra portions of fermented dairy products (skyr, ymer and yogurt) 1-2 days before the spot urine sample to be able to validate markers for specific foods. Receives: Other: Exposure: Plant-based diet pattern; Other: Intervention: Fermented dairy products; Other: Exposure: individual foods and food groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of Indole-3-lactic acid in blood
Difference in beta-coefficient of the concentration of Indole-3-lactic acid (https://hmdb.ca/metabolites/HMDB0000671) in blood measured at the end of the study between those consuming fermented dairy products compared to participants not consuming fermented dairy products. A linear regression model will be used with Indole-3-lactic acid concentration as the outcome and consuming vs not consuming fermented dairy products as the exposure.
Indole-3-lactic acid in blood will be analysed using an ultra-performance liquid chromatography (UPLC) system coupled to a quadrupole time-of-flight mass spectrometer (ViON QTOF, Waters Corporation, Manchester, UK).
Measured: 1 month
Secondary outcomes (3)
Concentration of Indole-3-lactic acid in urine
Difference in beta-coefficient of the concentration of Indole-3-lactic acid (https://hmdb.ca/metabolites/HMDB0000671) in the average of 7 spot urine samples between those consuming fermented dairy products compared to participants not consuming fermented dairy products. A linear regression model will be used with Indole-3-lactic acid concentration as the outcome and consuming vs not consuming fermented dairy products as the exposure.
Indole-3-lactic acid in urine will be analysed using an ultra-performance liquid chromatography (UPLC) system coupled to a quadrupole time-of-flight mass spectrometer (ViON QTOF, Waters Corporation, Manchester, UK).
Measured: 1 month
Concentration of 3-Phenyllactic acid in blood
Difference in beta-coefficient of the concentration of 3-Phenyllactic acid (https://hmdb.ca/metabolites/HMDB0000779) in blood measured at the end of the study between those consuming fermented dairy products compared to participants not consuming fermented dairy products. A linear regression model will be used with 3-Phenyllactic acid concentration as the outcome and consuming vs not consuming fermented dairy products as the exposure.
Indole-3-lactic acid in blood will be analysed using an ultra-performance liquid chromatography (UPLC) system coupled to a quadrupole time-of-flight mass spectrometer (ViON QTOF, Waters Corporation, Manchester, UK).
Measured: 1 month
Concentration of 3-Phenyllactic acid in urine
Difference in beta-coefficient of the concentration of 3-Phenyllactic acid (https://hmdb.ca/metabolites/HMDB0000779) in the average of 7 spot urine samples between those consuming fermented dairy products compared to participants not consuming fermented dairy products. A linear regression model will be used with 3-Phenyllactic acid concentration as the outcome and consuming vs not consuming fermented dairy products as the exposure.
Indole-3-lactic acid in urine will be analysed using an ultra-performance liquid chromatography (UPLC) system coupled to a quadrupole time-of-flight mass spectrometer (ViON QTOF, Waters Corporation, Manchester, UK).
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start1 Jun 2023
- Primary completion19 Mar 2024
- Study completion19 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, University of Aarhus
- Responsible party
- Sponsor
- Investigators
- Lars O Dragsted, PhD, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05887544
- Sponsor's protocol ID
- M244
- Acronym
- ODA
- Status last verified
- Jun 2024
- First submitted
- 25 Apr 2023
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once the project is finished, data will by fully anonymised and shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Towards Objective Dietary Assessment in Large-scale Studies
- ClinicalTrials.gov ID
- NCT05887544
- Acronym / sponsor ID
- ODA / M244
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- sampling, food intake biomarkers, type 2 diabetes, urine, blood, hair, diet assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, University of Aarhus
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 19 Mar 2024 (actual)
- Study completion
- 19 Mar 2024 (actual)
- First posted
- 2 Jun 2023 (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.
Enabling an objective measure of diet, covering individual foods as well as different dietary patterns, in large-scale studies has great potential; this would for instance improve our understanding of the role of diet in long-term disease prevention and care in people with type 2 diabetes.
The overarching aim of this study is to develop a framework from which dietary intake can be assessed, both as single foods and dietary patterns, in cohort studies among people with type 2 diabetes. This study is performed to assess which collection strategy best reflects long-term dietary intake and to weigh this up against feasibility and costs in large-scale studies.
Detailed description
This is a 4-week observational study that will be carried out in adults with newly diagnosed type 2 diabetes living in Denmark.
The aim is to recruit up to 60 participants aged 18-75. The participants will be asked to record and weight their habitual food intake on 8 days spread out within a one-month time period. They will also be asked to complete one 24-hour urine collection the day before study start and provide 7 morning spot urine samples on the subsequent mornings after filling in the food diary.
At the start of the study period participants will undergo a DXA scan and have a blood sample taken. At the end of the study period a second blood sample will be drawn and a hair sample will also be collected. Incomplete 24-hour collections will be judged based on predicted 24-hour creatinine excretion from lean body mass and actual creatinine excretion being in the interval from 0.8-1.2, which corresponds to ~20% on each side of the expected excretion. Participants falling outside this interval will be asked to complete a new 24-hour urine sample. As the primary aim of this study is validation, it is important that the samples provided are as complete as possible.
In the one-month period between visits to the study center, a subset of volunteer participants (up to 20 participants) will be asked to consume extra portions of fermented dairy products (skyr, ymer and yogurt) 1-2 days before the spot urine sample to be able to validate markers for specific foods. All participants in the subcohort will consume each of the foods one time before a spot urine and one time be asked to abstain intake of dairy products as a control. Foods will be provided to the participants.
Note: the study has ended with fewer participants than expected due to problems with recruitment. We will analyse these samples and work on samples from another study to answer our initial research questions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type 2 diabetes | – | Other: Exposure: Plant-based diet pattern, Other: Intervention: Fermented dairy products, Other: Exposure: individual foods and food groupsOverall study population. In addition, a subset of volunteer participants (up to 20 participants) will be asked to consume extra portions of fermented dairy products (skyr, ymer and yogurt) 1-2 days before the spot urine sample to be able to validate markers for specific foods. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with newly diagnosed type 2 diabetes that are otherwise generally health and willing to participate in the study.
Key inclusion criteria (10 listed)
- Newly diagnosed type 2 diabetes (within the last 5 years from study start) (self-reported)
- 18.5-35.0 kg/m2 BMI
- More than 1cm of natural hair on the head
- Have not dyed their hair in the previous 6 months
- Willing to record dietary intake up to 9 days
Key exclusion criteria (9 listed)
- Pregnant or lactating women
- Diagnosed with any chronic or communicable diseases including liver diseases (e.g., active hepatitis B and C infections), liver cirrhosis, severe psychiatric illness or any other clinical condition that makes the subject ineligible according to the clinically responsible medical doctor (except type 2 diabetes) (self-reported).
- History of cancer within the past 5 years (except adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer)
- Diagnosed with any CVD event (e.g., myocardial infarction, revascularization procedure or stroke) within the past 2 years
- Unintentional weight loss >20% during the last 6 months
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 |
|---|---|---|
| Exposure: Plant-based diet patternAlso: Plant-based diet indexFrom dietary records average intake across food groups will be calculated and a plant-based diet index score will be generated to group participants. | Other | Type 2 diabetes |
| Intervention: Fermented dairy productsAlso: Commercially available skyr, ymer and yogurt1000g of the product to be consumed 1-2 days prior to spot urine sample. | Other | Type 2 diabetes |
| Exposure: individual foods and food groupsAlso: Foods and food groupsFrom the dietary records, average intake of specific foods or food groups will be calcualted. | Other | Type 2 diabetes |
Primary outcome
Concentration of Indole-3-lactic acid in blood
Time frame: 1 month
Difference in beta-coefficient of the concentration of Indole-3-lactic acid (https://hmdb.ca/metabolites/HMDB0000671) in blood measured at the end of the study between those consuming fermented dairy products compared to participants not consuming fermented dairy products. A linear regression model will be used with Indole-3-lactic acid concentration as the outcome and consuming vs not consuming fermented dairy products as the exposure. Indole-3-lactic acid in blood will be analysed using an ultra-performance liquid chromatography (UPLC) system coupled to a quadrupole time-of-flight mass spectrometer (ViON QTOF, Waters Corporation, Manchester, UK).
3 secondary outcomes
Concentration of Indole-3-lactic acid in urine
Time frame: 1 month
Concentration of 3-Phenyllactic acid in blood
Time frame: 1 month
Concentration of 3-Phenyllactic acid in urine
Time frame: 1 month
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 13 Jun 2024.
- Individual participant dataSharing planned: Yes. Once the project is finished, data will by fully anonymised and shared with other researchers.
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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.
Lars O Dragsted, PhD principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by University of Copenhagen at 1 site in Denmark.
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 10 inclusion and 9 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 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Concentration of Indole-3-lactic acid in blood (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jun 2024.