Dietary Biomarkers 2.0: From Potential Towards Implementation.

Chalmers University of Technology

Status: Completed

Conditions: Healthy

Treatments: Other: Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT05073523

ChalmersUT

Details and patient eligibility

About

The aim of this project is to fill a gap in the translation of dietary biomarkers as unbiased measures of food intake from high-end academic research into a methodology that ca be easily applied across academic, public and private health sector to objectively assess specific dietary intakes at group and individuals' level to a) improve understanding of diet and health relationships b) address compliance in dietary intervention studies and c) assess individuals' dietary intakes to guide their eating towards improved health. The study will be carried out as a three-way cross-over design with three different meal compositions (A, B, C) where each meal is provided 3 times per day during four days per meal. A wash-out period of 7 days where participants consume their habitual diet is implemented and a 3-day run-in before the study meal intervention. The first day of study meal intervention includes postprandial measurements during 8 hours.

Enrollment: 22 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Men and women
• Age 18-80 years
• Body mass index (BMI) 18.5-30 kg/m2
• Fasting glucose ≤ 6.1 mmol/l
• Low density lipoprotein (LDL), Cholesterol ≤ 5.30 mmol/L
• Triglycerides ≤ 2.60 mmol/L
• Signed informed consent

Exclusion criteria

• Food allergies or intolerances preventing consumption of any products included in the study.
• Strict vegetarian or vegan, participants must be able to eat dairy products as it is included in the study diet.
• Unable to sufficiently understand written and spoken Swedish to provide written consent and understand information and instructions from the study personal.
• Unable to satisfactorily complete the 3-day weighted food records.
• Continuous/daily use of medication.
• Pregnant, lactating or planning a pregnancy during the study period.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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22 participants in 3 patient groups

Meal A

Other group

Description:

Diet: meal proportion 1

Treatment:

Other: Diet

Meal B

Other group

Description:

Diet: meal proportion 2

Treatment:

Other: Diet

Meal C

Other group

Description:

Diet: meal proportion 3

Treatment:

Other: Diet