Dietary Biomarkers 2.0: From Potential Towards Implementation.

NCT ID: NCT05073523

Last Updated: 2022-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-27
• Study Completion Date: 2022-10-28

Brief Summary

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Meal A

Diet: meal proportion 1

Group Type: OTHER

Diet

Intervention Type: OTHER

All intervention meals consist of five different food groups including fruits, vegetables, legumes, dairy products, and whole grains. Differences in the proportion of these foods in Meal A-C is tested.

Meal B

Diet: meal proportion 2

Group Type: OTHER

Diet

Intervention Type: OTHER

All intervention meals consist of five different food groups including fruits, vegetables, legumes, dairy products, and whole grains. Differences in the proportion of these foods in Meal A-C is tested.

Meal C

Diet: meal proportion 3

Group Type: OTHER

Diet

Intervention Type: OTHER

All intervention meals consist of five different food groups including fruits, vegetables, legumes, dairy products, and whole grains. Differences in the proportion of these foods in Meal A-C is tested.

Interventions

Diet

All intervention meals consist of five different food groups including fruits, vegetables, legumes, dairy products, and whole grains. Differences in the proportion of these foods in Meal A-C is tested.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chalmers University of Technology

OTHER

Sponsor Role: lead

Responsible Party

Rikard Landberg

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rikard Landberg, Dr

Role: PRINCIPAL_INVESTIGATOR

Chalmers University of Technology

Locations

University of Gothenburg, Department of Food and Nutrition and Sport Science

Gothenburg, , Sweden

Countries

Sweden

Other Identifiers

ChalmersUT

Identifier Type: -

Identifier Source: org_study_id