Metabolic ControlNUTRIOMENCT06842433
The NUTRIOME Study - a Data-driven Precision Nutrition Intervention
A study testing General healthy diet and Personalized diet in people with Metabolic Control, run by Chalmers University of Technology at 3 sites in 3 countries.
Trial summary
The overall objective of this multi-center study is to use metabolic response data from different dietary challenges to develop personalized dietary advice. Effectiveness of this personalized dietary advice compared to a general healthy diet based on national dietary guidelines on markers of cardio-metabolic health… Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Control
- What is being tested?
- General healthy diet and Personalized diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 14 Mar 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women
- Age 40 to 70 years
- Body mass index (BMI) 27-35 kg/m2
- Signed informed consent
Who cannot join
- History of diagnosed cardiovascular disease (e.g. stroke, heart disease)
- Diagnosed type 1 or type 2 diabetes
- Finger prick glucose test at screening indicating diabetes (fasting >6.9 mmol/L; non-fasting >11.0 mmol/L)
- Antibiotic use in the last 3 months
- Taking medication that can interfere with the planned outcome measures, as judged by the study physician (e.g. peroxisome proliferator-activated receptor-α [PPAR-α] or PPAR-γ agonists [fibrates], sulfonylureas, biguanides, α-glucosidase inhibitors, thiazolidinediones, repaglinide, nateglinide and insulin, chronic use of NSAIDs). Statins and hypertension medication are allowed if the medication regimen has been stable for the last three months
- Stomach and gastrointestinal conditions (e.g. Morbus Chron, Ulcerative colitis, irritable bowel syndrome, malabsorption, colostomy, bowel resection, gastric bypass surgery etc.)
Show all 25Show fewer
- History of major gastrointestinal surgery
- Anaemia: Hb concentrations < 8.5 mmol/L for men and < 7.5 mmol/L for women
- Recent blood donation (within 2 months prior to the screening)
- Recent participation in another intervention study (within 2 months prior to the screening)
- Allergy or intolerance to medical skin adhesives
- Chronic or acute inflammatory conditions (e.g., rheumatoid arthritis, psoriatic arthritis)
- Autoimmune disorders
- Thyroid disorders
- Significant renal or liver dysfunction or chronic kidney or liver disease
- Known food allergies/intolerances to intervention foods or food products used in the study
- Following specific dietary regimen that could impact results or not suitable for the study design (e.g. vegetarian, vegan)
- Habitual tobacco consumption (e.g. smoking, use of snus, vaping)
- Alcohol intake ≥ 14 alcoholic beverages/week for women and ≥ 21 alcoholic beverages/week for men
- Current or planned pregnancy or lactating
- Other serious medical conditions that could interfere with participation or study outcomes
- Unable to sufficiently understand written and spoken national language (where the study centre is located) to provide written consent and understand information and instructions from the study personnel.
- Deemed unsuitable for participation in the trial, for any reason, as judged by the research physician or PI.
- Working at the division conducting the trial at any of the three study centres.
- Do not have a mobile phone that is suitable for the use of a research app.
Trial locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 3 countries
Netherlands1 site, 1 recruiting
- Recruiting
Wageningen University and Research, Human research unit
Wageningen
Lydia Afman, +31317485789, lydia.afman@wur.nl
Norway1 site, 1 recruiting
- Recruiting
Department of nutrition, University of Oslo
Oslo
Stina Marie Ulven, +4722840208, smulven@medisin.uio.no
Sweden1 site, 1 recruiting
- Recruiting
University of Gothenburg, Department of Internal medicin and Clinical nutrition
Gothenburg
Rikard Landberg, +46317722732, rikard.landberg@chalmers.se
About this study
Official title: The NUTRIOME Meal Study - a Data-driven Precision Nutrition Intervention Study Using Meal Responses
The overall objective of this multi-center study is to use metabolic response data from different dietary challenges to develop personalized dietary advice. Effectiveness of this personalized dietary advice compared to a general healthy diet based on national dietary guidelines on markers of cardio-metabolic health will be tested.
A total of 120 men and women who meet all inclusion criteria and none of the exclusion criteria will be invited to participate. The study will be conducted at three sites: Chalmers University of Technology (Sweden), University of Wageningen (Netherlands), and University of Oslo (Norway), with 40 participants per site.The study is conducted in two parts. The first part, the characterization phase, is a three-way randomized, controlled cross-over design, featuring one-day meal tests with isocaloric meals containing different carbohydrate, fat and protein quantity as well as quality. Based on the metabolic response to the meal tests a personalized diet will be constructed. In the second part, the main intervention, effectiveness of this personalized dietary advice compared to a general healthy diet will be tested in a six week parallel group intervention study.
- Conditions
- Metabolic Control
- Being tested
- General healthy diet, Personalized diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General healthy dietOther
General healthy diet based on national health dietary guidelines.
Personalized dietOther
Personalized diet will be based on an algorithm considering the individuals' postprandial glucose, triglycerides and inflammation markers to each of the three study meals in the characterization phase (Phase I) matched with established knowledge about the effects of specific foods on such metabolic parameters.
| Study group | Role | What they receive |
|---|---|---|
| General healthy diet | Active comparator | General healthy diet based on national health dietary guidelines. Receives: Other: General healthy diet |
| Personalized diet | Experimental | Personalized diet will be based on an algorithm considering the individuals' postprandial glucose, triglycerides and inflammation markers to each of the three study meals in the characterization phase (Phase I) matched with established knowledge about the effects of specific foods on such metabolic parameters Receives: Other: Personalized diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose postprandial
Difference between groups in postprandial glucose in response to a mixed meal tolerance test.
Measured: 6 weeks
Triglycerides postprandial
Difference between groups in postprandial triglycerides in response to a mixed meal tolerance test.
Measured: 6 weeks
Interleukin-6 postprandial
Difference between groups in postprandial interleukin-6 in response to a mixed meal tolerance test.
Measured: 6 weeks
Secondary outcomes (20)
Inflammatory markers in blood
Differences in immunological responses (such as cytokines, lipopolysaccharides, GlycA) between test meals in the characterization phase of the study.
Measured: 6-hour meal test
Appetite
Differences in self-reported appetite measured using a visual analogue scale between test meals in the characterization phase of the study.
Measured: 6-hour meal test
Gut microbiome
Differences in fecal microbiome between test meals in the characterization phase of the study.
Measured: 6-hour meal test
Metabolome
Differences in metabolome (plasma, urine and feces) between test meals in the characterization phase of the study.
Measured: 6-hour meal test
Lipid metabolism
Differences in lipid metabolism between test meals in the characterization phase of the study.
Measured: 6-hour meal test
Glycemic variability
Differences in glycemic variability across the different meals and the OGTT throughout the characterization phase of the study.
Measured: 4 weeks
Gastrointestinal hormones
Release of gastrointestinal hormones (such as GLP-1, CCK) in response to the test meals in the characterization phase of the study.
Measured: 6-hour meal test
Fecal proteome
Differences in fecal proteome between test meals in the characterization phase of the study.
Measured: 6-hour meal test
PBMC Transcriptome
Differences in peripheral blood mononuclear cell gene expression between test meals in the characterization phase of the study.
Measured: 6-hour meal test
PBMC Epigenome
Differences in peripheral blood mononuclear cell epigenome between test meals in the characterization phase of the study.
Measured: 6-hour meal test
PBMC Immunometabolism
Differences in peripheral blood mononuclear cell immunometabolism between test meals in the characterization phase of the study.
Measured: 6-hour meal test
Metabolome
Difference in metabolome (plasma, urine and feces) between personalized diet and general healthy diet in the intervention phase of the study.
Measured: 6 weeks
PBMC Epigenome
Difference in peripheral blood mononuclear cell epigenome between personalized diet and general healthy diet in the intervention phase of the study.
Measured: 6 weeks
PBMC Transcriptome
Difference in peripheral blood mononuclear cell transcriptome between personalized diet and general healthy diet in the intervention phase of the study.
Measured: 6 weeks
PBMC Immunometabolism
Difference in peripheral blood mononuclear cell immunometabolism between personalized diet and general healthy diet in the intervention phase of the study.
Measured: 6 weeks
Fecal proteome
Difference in fecal proteome between personalized diet and general healthy diet in the intervention phase of the study.
Measured: 6 weeks
Gut microbiome
Difference in fecal microbiome between personalized diet and general healthy diet in the intervention phase of the study.
Measured: 6 weeks
Inflammatory markers in blood
Differences in immunological responses (such as cytokines, lipopolysaccharides, GlycA) to mixed meal tolerance tests between personalized diet and general healthy diet in the intervention phase of the study.
Measured: 6 weeks
Glycemic variability
Differences in glycemic variability between personalized diet and general healthy diet in the intervention phase of the study.
Measured: 6 weeks
Data-driven prediction of response to intervention
Data-driven prediction of primary and other outcomes to personalized diet vs. general healthy diet using metabolome, gut microbiome, epigenome, transcriptome, proteome, immunometabolism, health measures, lifestyle and metabolic markers as determinants.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start14 Mar 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic ControlStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chalmers University of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo, Wageningen University, Polish Academy of Sciences, Maastricht University, German Cancer Research Center, University of Copenhagen, University of Oulu, University College Dublin
- Responsible party
- Principal investigator, Rikard Landberg, Chalmers University of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06842433
- Sponsor's protocol ID
- Nutriome
- Acronym
- NUTRIOME
- Status last verified
- Mar 2025
- First submitted
- 30 Jan 2025
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The NUTRIOME Meal Study - a Data-driven Precision Nutrition Intervention Study Using Meal Responses
- ClinicalTrials.gov ID
- NCT06842433
- Acronym / sponsor ID
- NUTRIOME / Nutriome
- Conditions
- Metabolic Control
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Chalmers University of TechnologyUniversity, hospital or other
- Collaborators
- University of Oslo, Wageningen University, Polish Academy of Sciences, Maastricht University, German Cancer Research Center, University of Copenhagen, University of Oulu, University College Dublin
- Study start
- 14 Mar 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 24 Feb 2025 (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 overall objective of this multi-center study is to use metabolic response data from different dietary challenges to develop personalized dietary advice. Effectiveness of this personalized dietary advice compared to a general healthy diet based on national dietary guidelines on markers of cardio-metabolic health will be tested.
A total of 120 men and women who meet all inclusion criteria and none of the exclusion criteria will be invited to participate. The study will be conducted at three sites: Chalmers University of Technology (Sweden), University of Wageningen (Netherlands), and University of Oslo (Norway), with 40 participants per site.The study is conducted in two parts. The first part, the characterization phase, is a three-way randomized, controlled cross-over design, featuring one-day meal tests with isocaloric meals containing different carbohydrate, fat and protein quantity as well as quality. Based on the metabolic response to the meal tests a personalized diet will be constructed. In the second part, the main intervention, effectiveness of this personalized dietary advice compared to a general healthy diet will be tested in a six week parallel group intervention study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General healthy diet | Active comparator | Other: General healthy dietGeneral healthy diet based on national health dietary guidelines. |
| Personalized diet | Experimental | Other: Personalized dietPersonalized diet will be based on an algorithm considering the individuals' postprandial glucose, triglycerides and inflammation markers to each of the three study meals in the characterization phase (Phase I) matched with established knowledge about the effects of specific foods on such metabolic parameters |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women
- Age 40 to 70 years
- Body mass index (BMI) 27-35 kg/m2
- Signed informed consent
Key exclusion criteria (25 listed)
- History of diagnosed cardiovascular disease (e.g. stroke, heart disease)
- Diagnosed type 1 or type 2 diabetes
- Finger prick glucose test at screening indicating diabetes (fasting >6.9 mmol/L; non-fasting >11.0 mmol/L)
- Antibiotic use in the last 3 months
- Taking medication that can interfere with the planned outcome measures, as judged by the study physician (e.g. peroxisome proliferator-activated receptor-α [PPAR-α] or PPAR-γ agonists [fibrates], sulfonylureas, biguanides, α-glucosidase inhibitors, thiazolidinediones, repaglinide, nateglinide and insulin, chronic use of NSAIDs). Statins and hypertension medication are allowed if the medication regimen has been stable for the last three months
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 |
|---|---|---|
| General healthy dietGeneral healthy diet based on national health dietary guidelines. | Other | General healthy diet |
| Personalized dietPersonalized diet will be based on an algorithm considering the individuals' postprandial glucose, triglycerides and inflammation markers to each of the three study meals in the characterization phase (Phase I) matched with established knowledge about the effects of specific foods on such metabolic parameters. | Other | Personalized diet |
Primary outcome
Glucose postprandial
Time frame: 6 weeks
Difference between groups in postprandial glucose in response to a mixed meal tolerance test.
Triglycerides postprandial
Time frame: 6 weeks
Difference between groups in postprandial triglycerides in response to a mixed meal tolerance test.
Interleukin-6 postprandial
Time frame: 6 weeks
Difference between groups in postprandial interleukin-6 in response to a mixed meal tolerance test.
20 secondary outcomes
Inflammatory markers in blood
Time frame: 6-hour meal test
Appetite
Time frame: 6-hour meal test
Gut microbiome
Time frame: 6-hour meal test
Metabolome
Time frame: 6-hour meal test
Lipid metabolism
Time frame: 6-hour meal test
Glycemic variability
Time frame: 4 weeks
Gastrointestinal hormones
Time frame: 6-hour meal test
Fecal proteome
Time frame: 6-hour meal test
PBMC Transcriptome
Time frame: 6-hour meal test
PBMC Epigenome
Time frame: 6-hour meal test
PBMC Immunometabolism
Time frame: 6-hour meal test
Metabolome
Time frame: 6 weeks
PBMC Epigenome
Time frame: 6 weeks
PBMC Transcriptome
Time frame: 6 weeks
PBMC Immunometabolism
Time frame: 6 weeks
Fecal proteome
Time frame: 6 weeks
Gut microbiome
Time frame: 6 weeks
Inflammatory markers in blood
Time frame: 6 weeks
Glycemic variability
Time frame: 6 weeks
Data-driven prediction of response to intervention
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing General healthy diet and Personalized diet in people with Metabolic Control, run by Chalmers University of Technology at 3 sites in 3 countries.
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 4 inclusion and 25 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: looking for participants now, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands, Norway, 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rikard Landberg, PhD (+46723509386, rikard.landberg@chalmers.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose postprandial (time frame: 6 weeks). The study lists 3 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 21 Mar 2025.