Dietary Biomarkers 2.0: From Potential Towards Implementation.

November 14, 2022 updated by: Rikard Landberg, Chalmers University of Technology

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Plasma concentrations of dietary candidate biomarkers (daidzein, genistein, hesperetin, naringenin, phloretin, kaempferol, 2-thiothiazolidine-4-carboxylic acid, sulforaphane)
Time Frame: 24 hours
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)
Time Frame: 24 hours
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)
Time Frame: 24 hours
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
Time Frame: 24 hours
Differences in plasma AUCs between the three intake levels.
24 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Gut microbiome
Time Frame: 4 days
Fecal samples will analyzed for composition of the gut microbiome, baseline compared with after 4 days of intervention meals.
4 days
Plasma metabolites
Time Frame: 4 days
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
Time Frame: 24 hours
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
Time Frame: 4 days
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)
Time Frame: 4 days
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
Time Frame: 4 days
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)
Time Frame: 4 days
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
Time Frame: 4 days
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
Time Frame: 4 days
Evaluate new simple sampling techniques using dried urine spots.
4 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chalmers University of Technology

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rikard Landberg, Dr, Chalmers University of Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 27, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 28, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 28, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 6, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 11, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 15, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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