Towards Objective Dietary Assessment in Large-scale Studies

NCT05887544 | Completed

• 1 other identifier: M244
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

sampling; food intake biomarkers; type 2 diabetes; urine; blood; hair; diet assessment

Outcome Measures

Primary Outcomes (1)

• 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).

  1 month

Secondary Outcomes (3)

• Concentration of Indole-3-lactic acid in urine

  1 month

• Concentration of 3-Phenyllactic acid in blood

  1 month

• Concentration of 3-Phenyllactic acid in urine

  1 month

Other Outcomes (1)

• Exploratory analyses

  1 day or 1 month

Study Arms (1)

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.

Other: Exposure: Plant-based diet pattern; Other: Intervention: Fermented dairy products; Other: Exposure: individual foods and food groups

Interventions

Exposure: Plant-based diet pattern 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.

Also known as: Plant-based diet index

Type 2 diabetes

Intervention: Fermented dairy products OTHER

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

Also known as: Commercially available skyr, ymer and yogurt

Type 2 diabetes

Exposure: individual foods and food groups OTHER

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

Also known as: Foods and food groups

Type 2 diabetes

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with newly diagnosed type 2 diabetes that are otherwise generally health and willing to participate in the study.

You may qualify if:

• Newly diagnosed type 2 diabetes (within the last 5 years from study start) (self-reported)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Copenhagen: lead
• Aarhus University Hospital: collaborator
• University of Aarhus: collaborator

Study Sites (1)

Department of Nutrition, Exercise and Sports, University of Copenhagen

Copenhagen, Frederiksberg C, 1958, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood, urine and hair samples.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Yogurt; Food

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Cultured Milk Products; Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Fermented Foods; Dairy Products; Food and Beverages

Study Officials

• Lars O Dragsted, PhD

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: June 2, 2023
• Study Start: June 1, 2023
• Primary Completion: March 19, 2024
• Study Completion: March 19, 2024
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After completion of the main study project.
• Access Criteria: Will be uploaded on University of Copenhagen data sharing platform. More information to come.

Locations

DK (1)