Nutrition DisordersNCT02039596
Nutritional Metabolomics: the Search for Dietary Exposure Variables
A study testing Diet in people with Nutrition Disorders and Metabolic Disorders, run by Göteborg University at 1 site in Sweden.
Trial summary
In the post-genomic era, a major challenge for health research is to understand the complex interactions among genetic, environmental and lifestyle factors including dietary intake. Unfortunately, such initiatives are hampered by the lack of accurate dietary intake assessment methods for large studies. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition Disorders, Metabolic Disorders
- What is being tested?
- Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2012to Nov 2013
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index 18.5-30.0
- Age 18-65 years old
Who cannot join
- Medications or tobacco use
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Dept Internal Medicine and Clinical Nutrition, Univ of Gothenburg
Gothenburg, S-40530
About this study
In the post-genomic era, a major challenge for health research is to understand the complex interactions among genetic, environmental and lifestyle factors including dietary intake. Unfortunately, such initiatives are hampered by the lack of accurate dietary intake assessment methods for large studies. The newly emerging field of metabolomics offers unique possibilities to characterize individual food intake, dietary patterns and effects of dietary intervention in large studies. The investigators propose to develop a platform to detect broad metabolomic responses to food intake in controlled trials as well as to use targeted metabolomics approaches to characterize dietary intake in longitudinal studies. Our laboratory has a long history of developing methodology for assessing nutritional status and effects of diet on metabolism. Here, the investigators team up with the Sahlgrenska Academy Core Facility and the Swedish NMR Centre at the University of Gothenburg, that offer modern metabolomics equipment and competence in bioinformatics, and use this in the context of nutrition research. To their knowledge, the investigators are among the first groups in the country to develop skills in metabolomics to assess dietary intake and effects of nutrition on metabolism, and probably the first to use two complementary platforms with both mass-spectrometry and nuclear magnetic spectroscopy. Hence, our methodological results should be useful to nutritional scientists nationally as well as internationally.
- Conditions
- Nutrition Disorders, Metabolic Disorders
- Being tested
- Diet
- Medical subject headings
- Nutrition Disorders, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietOther
| Study group | Role | What they receive |
|---|---|---|
| vegetarian breakfast | Experimental | Diet: Vegetarian food items Receives: Other: Diet |
| Swedish Breakfast | Experimental | Diet: Swedish food items Receives: Other: Diet |
| English breakfast | Experimental | Diet: English food items Receives: Other: Diet |
| Lacto-vegetarian breakfast | Experimental | Diet: Lacto-vegetarian food items Receives: Other: Diet |
| Swedish omnivore breakfast | Experimental | Diet: Swedish breakfast with meat items Receives: Other: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute metabolomic response
The acute metabolomic response (ie all metabolites) to a test meal will be analyzed using both nuclear magnetic resonance (NMR) and mass spectrometry (MS) techniques. Patterns of metabolites will be evaluated with statistical techniques, ie discriminant analysis and principal component analysis.
Measured: Directly after ingestion of test meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2014 (estimated)
- Study startSep 2012
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nutrition DisordersStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna K Winkvist, PhD, Principal investigator, Univ of Gothenburg, SwedenLars H Ellegard, PhD, MD, Study chair, Univ of GothenburgHelen M Lindqvist, PhD, Study director, Univ of Gothenburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02039596
- Sponsor's protocol ID
- Nutritional Metabolomics AIKN
- Other IDs
- 2011-20497-84904-38
- Status last verified
- Jan 2014
- First submitted
- 17 Dec 2013
- Last updated
- 17 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Radjursoga M, Lindqvist HM, Pedersen A, Karlsson GB, Malmodin D, Brunius C, Ellegard L, Winkvist A. The 1H NMR serum metabolomics response to a two meal challenge: a cross-over dietary intervention study in healthy human volunteers. Nutr J. 2019 Apr 8;18(1):25. doi: 10.1186/s12937-019-0446-2.
PubMed 30961592
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Metabolomics: the Search for Dietary Exposure Variables
- ClinicalTrials.gov ID
- NCT02039596
- Acronym / sponsor ID
- Nutritional Metabolomics AIKN
- Conditions
- Nutrition Disorders, Metabolic Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 17 Jan 2014 (estimated)
- 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.
In the post-genomic era, a major challenge for health research is to understand the complex interactions among genetic, environmental and lifestyle factors including dietary intake. Unfortunately, such initiatives are hampered by the lack of accurate dietary intake assessment methods for large studies. The newly emerging field of metabolomics offers unique possibilities to characterize individual food intake, dietary patterns and effects of dietary intervention in large studies. The investigators propose to develop a platform to detect broad metabolomic responses to food intake in controlled trials as well as to use targeted metabolomics approaches to characterize dietary intake in longitudinal studies. Our laboratory has a long history of developing methodology for assessing nutritional status and effects of diet on metabolism. Here, the investigators team up with the Sahlgrenska Academy Core Facility and the Swedish NMR Centre at the University of Gothenburg, that offer modern metabolomics equipment and competence in bioinformatics, and use this in the context of nutrition research. To their knowledge, the investigators are among the first groups in the country to develop skills in metabolomics to assess dietary intake and effects of nutrition on metabolism, and probably the first to use two complementary platforms with both mass-spectrometry and nuclear magnetic spectroscopy. Hence, our methodological results should be useful to nutritional scientists nationally as well as internationally.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| vegetarian breakfast | Experimental | Other: DietDiet: Vegetarian food items |
| Swedish Breakfast | Experimental | Other: DietDiet: Swedish food items |
| English breakfast | Experimental | Other: DietDiet: English food items |
| Lacto-vegetarian breakfast | Experimental | Other: DietDiet: Lacto-vegetarian food items |
| Swedish omnivore breakfast | Experimental | Other: DietDiet: Swedish breakfast with meat items |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Body mass index 18.5-30.0
- Age 18-65 years old
Key exclusion criteria (1 listed)
- Medications or tobacco use
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 |
|---|---|---|
| Diet | Other | English breakfast, Lacto-vegetarian breakfast, Swedish Breakfast, Swedish omnivore breakfast, vegetarian breakfast |
Primary outcome
Acute metabolomic response
Time frame: Directly after ingestion of test meal
The acute metabolomic response (ie all metabolites) to a test meal will be analyzed using both nuclear magnetic resonance (NMR) and mass spectrometry (MS) techniques. Patterns of metabolites will be evaluated with statistical techniques, ie discriminant analysis and principal component analysis.
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 17 Jan 2014.
- Derived from this study: PubMed 30961592Radjursoga M, Lindqvist HM, Pedersen A, Karlsson GB, Malmodin D, Brunius C, Ellegard L, Winkvist A. The 1H NMR serum metabolomics response to a two meal challenge: a cross-over dietary intervention study in healthy human volunteers. Nutr J. 2019 Apr 8;18(1):25. doi: 10.1186/s12937-019-0446-2.
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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.
Anna K Winkvist, PhD principal investigator
Univ of Gothenburg, Sweden
Lars H Ellegard, PhD, MD study chair
Univ of Gothenburg
Helen M Lindqvist, PhD study director
Univ of Gothenburg
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 Nutrition Disorders and Metabolic Disorders, run by Göteborg University 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 2 inclusion and 1 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 17 Jan 2014. 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?
Acute metabolomic response (time frame: Directly after ingestion of test meal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02039596, which also lists 1 linked publication.
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 17 Jan 2014.