NCT05887544Completed
Towards Objective Dietary Assessment in Large-scale Studies
Source: ClinicalTrials.gov · Last updated 13 Jun 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 4 (actual)
- First submitted
- 25 Apr 2023
- Start date
- 1 Jun 2023
- Primary completion date
- 19 Mar 2024
- Lead sponsor
- University of Copenhagen
- Diseases
- Type 2 diabetes
- NCT number
- NCT05887544
What you commit to
- Study type: Observational
- Participants enrolled: 4
- From 1 Jun 2023 to the primary completion date, 19 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent participation in another trial
Other illness
- 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
- Regular intake of prescription medication (except diabetes medication, blood pressure-lowering medication, cholesterol-lowering medication, mild antidepressants or contraceptive pills)
Other
- Pregnant or lactating women
- Unintentional weight loss \>20% during the last 6 months
- Not willing to sign the Informed consent form (ICF)
- Not willing to comply with the all the trial procedures
Who the study is looking for
- 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
- 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
Age in the registry: 18 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Nutrition, Exercise and Sports, University of Copenhagen Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.