HealthyNCT02039609
Nutritional Metabolomics: the Search for Dietary Exposure Variables 2
An observational study of Healthy, 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
- Healthy
- How many people
- 120 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2013to Jan 2016
- Phase
- Observational
- 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
Study population: Healthy subjects Adults
Who may be able to join
- Healthy Body mass index 18.0-30.0, age 18-65 yrs
Who cannot join
- Regular Medication or tobacco use Pregnancy or lactating
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
- Healthy
- Keywords
- vegetarian, vegan, omnivore, Habitual diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Omnivores | No intervention, habitual diet | |
| Vegetarians | No intervention, habitual diet | |
| Vegans | No intervention, habitual diet | |
| Vegetarians consuming fish | No intervention, habitual diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolomic patterns that reflect habitual diet
Long-time vegans, vegetarians and omnivores will be asked to donate a fasting blood sample at one occasion, in the early morning. This blood sample will be analyzed, using nuclear magnetic resonance (NMR) and mass spectrometry (MS) techniques to reveal all metabolites. Patterns among these metabolites will be distinguished using the statistical techniques principal component analysis and discriminant analysis.
Measured: Fasting blood sample in the morning at one occasion
Secondary outcomes (1)
Discriminating vegan-, vegetarian- and omnivorous diets by hair isotopic analysis
The same study group also was asked to donate 5-10 hairs of 2 cm closest to the scalp. These were analyzed using isotope ratios of 15N and 13C by IRMS, to see if also this method could discriminate between the groups
Measured: Hair samples in the morning at one occasion
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 startFeb 2013
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 120 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 Gothenburg, SwedenHelen M Lindqvist, Study director, Univ of Gothenburg, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02039609
- Sponsor's protocol ID
- Nutritional Metabolomics AIKN2
- Status last verified
- Aug 2018
- First submitted
- 17 Dec 2013
- Last updated
- 15 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Lindqvist HM, Radjursoga M, Torstensson T, Jansson L, Ellegard L, Winkvist A. Urine Metabolite Profiles and Nutrient Intake Based on 4-Day Weighed Food Diary in Habitual Vegans, Vegetarians, and Omnivores. J Nutr. 2021 Jan 4;151(1):30-39. doi: 10.1093/jn/nxaa019.
PubMed 32047921Lindqvist HM, Radjursoga M, Malmodin D, Winkvist A, Ellegard L. Serum metabolite profiles of habitual diet: evaluation by 1H-nuclear magnetic resonance analysis. Am J Clin Nutr. 2019 Jul 1;110(1):53-62. doi: 10.1093/ajcn/nqz032.
PubMed 31127814
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Metabolomics: the Search for Dietary Exposure Variables 2
- ClinicalTrials.gov ID
- NCT02039609
- Acronym / sponsor ID
- Nutritional Metabolomics AIKN2
- Conditions
- Healthy
- Keywords
- vegetarian, vegan, omnivore, Habitual diet
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- Feb 2013 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (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
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Omnivores | – | –No intervention, habitual diet |
| Vegetarians | – | –No intervention, habitual diet |
| Vegans | – | –No intervention, habitual diet |
| Vegetarians consuming fish | – | –No intervention, habitual diet |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy subjects Adults
Key inclusion criteria (1 listed)
- Healthy Body mass index 18.0-30.0, age 18-65 yrs
Key exclusion criteria (1 listed)
- Regular Medication or tobacco use Pregnancy or lactating
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Metabolomic patterns that reflect habitual diet
Time frame: Fasting blood sample in the morning at one occasion
Long-time vegans, vegetarians and omnivores will be asked to donate a fasting blood sample at one occasion, in the early morning. This blood sample will be analyzed, using nuclear magnetic resonance (NMR) and mass spectrometry (MS) techniques to reveal all metabolites. Patterns among these metabolites will be distinguished using the statistical techniques principal component analysis and discriminant analysis.
1 secondary outcome
Discriminating vegan-, vegetarian- and omnivorous diets by hair isotopic analysis
Time frame: Hair samples in the morning at one occasion
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 Aug 2018.
- Derived from this study: PubMed 32047921Lindqvist HM, Radjursoga M, Torstensson T, Jansson L, Ellegard L, Winkvist A. Urine Metabolite Profiles and Nutrient Intake Based on 4-Day Weighed Food Diary in Habitual Vegans, Vegetarians, and Omnivores. J Nutr. 2021 Jan 4;151(1):30-39. doi: 10.1093/jn/nxaa019.
- Derived from this study: PubMed 31127814Lindqvist HM, Radjursoga M, Malmodin D, Winkvist A, Ellegard L. Serum metabolite profiles of habitual diet: evaluation by 1H-nuclear magnetic resonance analysis. Am J Clin Nutr. 2019 Jul 1;110(1):53-62. doi: 10.1093/ajcn/nqz032.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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, Sweden
Helen M Lindqvist study director
Univ of Gothenburg, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, 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 1 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 15 Aug 2018. 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?
Metabolomic patterns that reflect habitual diet (time frame: Fasting blood sample in the morning at one occasion). 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 NCT02039609, which also lists 2 linked publications.
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 Aug 2018.