Towards Objective Dietary Assessment in Large-scale Studies

NCT ID: NCT05887544

Last Updated: 2024-06-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 4 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2024-03-19

Brief 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.

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Exposure: Plant-based diet pattern

Intervention Type: OTHER

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 products

Intervention Type: OTHER

1000g of the product to be consumed 1-2 days prior to spot urine sample.

Exposure: individual foods and food groups

Intervention Type: OTHER

From the dietary records, average intake of specific foods or food groups will be calcualted.

Interventions

Exposure: Plant-based diet pattern

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 Type: OTHER

Intervention: Fermented dairy products

1000g of the product to be consumed 1-2 days prior to spot urine sample.

Intervention Type: OTHER

Exposure: individual foods and food groups

From the dietary records, average intake of specific foods or food groups will be calcualted.

Intervention Type: OTHER

Other Intervention Names

Plant-based diet index; Commercially available skyr, ymer and yogurt; Foods and food groups

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)
• Concurrent participation in another trial
• Not willing to sign the Informed consent form (ICF)
• Not willing to comply with the all the trial procedures

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aarhus University Hospital

OTHER

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: collaborator

University of Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lars O Dragsted, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen

Locations

Department of Nutrition, Exercise and Sports, University of Copenhagen

Copenhagen, Frederiksberg C, Denmark

Countries

Denmark

Other Identifiers

M244

Identifier Type: -

Identifier Source: org_study_id