HealthyNCT05073523
Dietary Biomarkers 2.0: From Potential Towards Implementation.
A study testing Diet in people with Healthy, run by Chalmers University of Technology at 1 site in Sweden.
Trial 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'… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSweden
- Study dates
- 27 Sep 2021to 28 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Sweden1 site
University of Gothenburg, Department of Food and Nutrition and Sport Science
Gothenburg
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- Diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Meal A | Other | Diet: meal proportion 1 Receives: Other: Diet |
| Meal B | Other | Diet: meal proportion 2 Receives: Other: Diet |
| Meal C | Other | Diet: meal proportion 3 Receives: Other: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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
Measured: 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.
Measured: 24 hours
Secondary outcomes (9)
Gut microbiome
Fecal samples will analyzed for composition of the gut microbiome, baseline compared with after 4 days of intervention meals.
Measured: 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.
Measured: 4 days
Urine metabolites
Analyzed exploratorily using untargeted metabolomics to find potential biomarker panels that reflect the specific foods included in study meals.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start27 Sep 2021
- Primary completion28 Oct 2022
- Study completion28 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chalmers University of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rikard Landberg, Chalmers University of Technology
- Investigators
- Rikard Landberg, Dr, Principal investigator, Chalmers University of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05073523
- Sponsor's protocol ID
- ChalmersUT
- Status last verified
- Nov 2022
- First submitted
- 6 Sep 2021
- Last updated
- 15 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Biomarkers 2.0: From Potential Towards Implementation. A Randomized Controlled Trial to Assess Dose-response Relationships for Dietary Biomarkers of Selected Foods
- ClinicalTrials.gov ID
- NCT05073523
- Acronym / sponsor ID
- ChalmersUT
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Chalmers University of TechnologyUniversity, hospital or other
- Study start
- 27 Sep 2021 (actual)
- Primary completion
- 28 Oct 2022 (actual)
- Study completion
- 28 Oct 2022 (actual)
- First posted
- 11 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Meal A | Other | Other: DietDiet: meal proportion 1 |
| Meal B | Other | Other: DietDiet: meal proportion 2 |
| Meal C | Other | Other: DietDiet: meal proportion 3 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DietAll 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 A, Meal B, Meal C |
Primary outcome
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).
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).
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
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.
9 secondary outcomes
Gut microbiome
Time frame: 4 days
Plasma metabolites
Time frame: 4 days
Urine metabolites
Time frame: 24 hours
Fecal concentrations of diet specific biomarkers daidzein, genistein, hesperetin, naringenin, phloretin, kaempferol, 2-thiothiazolidine-4-carboxylic acid, sulforaphane
Time frame: 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
Blood concentrations of diet specific biomarkers daidzein, genistein, hesperetin, naringenin, phloretin, kaempferol, 2-thiothiazolidine-4-carboxylic acid, sulforaphane
Time frame: 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
Urine concentrations of diet specific biomarkers daidzein, genistein, hesperetin, naringenin, phloretin, kaempferol, 2-thiothiazolidine-4-carboxylic acid, sulforaphane
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rikard Landberg, Dr principal investigator
Chalmers University of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet in people with Healthy, run by Chalmers University of Technology at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma concentrations of dietary candidate biomarkers (daidzein, genistein, hesperetin, naringenin, phloretin, kaempferol, 2-thiothiazolidine-4-carboxylic acid, sulforaphane) (time frame: 24 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2022.