Dietary Biomarkers 2.0: From Potential Towards Implementation.

Dietary Biomarkers 2.0: From Potential Towards Implementation. A Randomized Controlled Trial to Assess Dose-response Relationships for Dietary Biomarkers of Selected Foods

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Diet

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Meal A; Diet: meal proportion 1	Other: 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.
Other: Meal B; Diet: meal proportion 2	Other: 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.
Other: Meal C; Diet: meal proportion 3	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma concentrations of dietary candidate biomarkers (daidzein, genistein, hesperetin, naringenin, phloretin, kaempferol, 2-thiothiazolidine-4-carboxylic acid, sulforaphane)	Difference in the plasma concentrations of diet specific biomarkers comparing before (baseline) and after intervention meal (average plasma concentration over the 24h period).	24 hours
Plasma concentrations of dietary biomarker candidates (proline betaine, 4-hydroxyphenylacetic acid, 4-hydroxyphenylpyruvate, indole-3-lactic acid, pipecolic acid, s-methylcysteine, avenacoside-A and avenacoside-B)	Difference in the plasma concentrations of diet specific biomarkers comparing before (baseline) and after intervention meal (average plasma concentration over the 24 h period).	24 hours
Plasma concentration-time profile over 24h (AUCs) of dietary biomarker candidates ( daidzein, genistein, hesperetin, naringenin, phloretin, kaempferol, 2-thiothiazolidine-4-carboxylic acid, sulforaphane)	Differences in plasma AUCs between the three intake levels for each biomarker candidate	24 hours
Plasma concentration-time profile over 24h (AUCs) of dietary biomarker candidates proline betaine, 4-hydroxyphenylacetic acid, 4-hydroxyphenylpyruvate, indole-3-lactic acid, pipecolic acid, s-methylcysteine, avenacoside-A and avenacoside-B	Differences in plasma AUCs between the three intake levels.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gut microbiome	Fecal samples will analyzed for composition of the gut microbiome, baseline compared with after 4 days of intervention meals.	4 days
Plasma metabolites	Untargeted metabolomics will be performed using established methods for plasma. Analyzed exploratorily using untargeted metabolomics to find potential biomarker panels that reflect the specific foods included in study meals. Baseline compared with after intervention meals.	4 days
Urine metabolites	Analyzed exploratorily using untargeted metabolomics to find potential biomarker panels that reflect the specific foods included in study meals.	24 hours
Fecal concentrations of diet specific biomarkers daidzein, genistein, hesperetin, naringenin, phloretin, kaempferol, 2-thiothiazolidine-4-carboxylic acid, sulforaphane	Evaluate new simple sampling techniques using faecal swabs.	4 days
Fecal concentrations of diet specific biomarkers proline betaine, 4-hydroxyphenylacetic acid, 4-hydroxyphenylpyruvate, indole-3-lactic acid, pipecolic acid, s-methylcysteine, avenacoside-A and avenacoside-B)	Evaluate new simple sampling techniques using fecal swabs.	4 days
Blood concentrations of diet specific biomarkers daidzein, genistein, hesperetin, naringenin, phloretin, kaempferol, 2-thiothiazolidine-4-carboxylic acid, sulforaphane	Evaluate new simple sampling techniques using dried blood spots.	4 days
Blood concentrations of diet specific biomarkers proline betaine, 4-hydroxyphenylacetic acid, 4-hydroxyphenylpyruvate, indole-3-lactic acid, pipecolic acid, s-methylcysteine, avenacoside-A and avenacoside-B)	Evaluate new simple sampling techniques using dried blood spots.	4 days
Urine concentrations of diet specific biomarkers daidzein, genistein, hesperetin, naringenin, phloretin, kaempferol, 2-thiothiazolidine-4-carboxylic acid, sulforaphane	Evaluate new simple sampling techniques using dried urine spots.	4 days
Blood concentrations of diet specific biomarkers proline betaine, 4-hydroxyphenylacetic acid, 4-hydroxyphenylpyruvate, indole-3-lactic acid, pipecolic acid, s-methylcysteine, avenacoside-A and avenacoside-B	Evaluate new simple sampling techniques using dried urine spots.	4 days

Collaborators and Investigators

• Sponsor: Chalmers University of Technology
• Investigators: Principal Investigator: Rikard Landberg, Dr, Chalmers University of Technology

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2021
• Primary Completion (Actual): October 28, 2022
• Study Completion (Actual): October 28, 2022

Study Registration Dates

• First Submitted: September 6, 2021
• First Submitted That Met QC Criteria: September 28, 2021
• First Posted (Actual): October 11, 2021

Study Record Updates

• Last Update Posted (Actual): November 15, 2022
• Last Update Submitted That Met QC Criteria: November 14, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: ChalmersUT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No