HealthyNCT03892486
Polyunsaturated Fatty Acids Supplementation and Blood Metabolome
A study testing The high PUFA diet group in people with Healthy, run by Poznan University of Life Sciences at 1 site in Poland.
Trial summary
Analysis of the effect of dietary intervention based on increased polyunsaturated fatty acid intake on health. Specifically changes in blood lipid profile, as well as proteomic and metabolomic profiles of healthy adults will be analyzed. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- The high PUFA diet group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2019to Jun 2019
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- good health,
- proper body weight
- not meeting the needs for polyunsaturated fatty acids
Who cannot join
- increased body weight,
- limited communication to an extent that makes it impossible to carry out a food interview,
- eating disorders (according to food history),
- metabolic diseases,
- pregnancy,
- lactation,
- taking drugs that influence the metabolism of lipids or carbohydrates
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Poznan University of Life Sciences
Poznan
Agata Chmurzynska
About this study
Official title: Analysis of the Effect of a Diet Enriched With Polyunsaturated Fatty Acids on the Proteomic and Metabolomic Profiles of Blood Plasma of Healthy People Aged 18-50
Analysis of the effect of dietary intervention based on increased polyunsaturated fatty acid intake on health. Specifically changes in blood lipid profile, as well as proteomic and metabolomic profiles of healthy adults will be analyzed.
- Conditions
- Healthy
- Being tested
- The high PUFA diet group
- Keywords
- metabolomics, proteomics, PUFA, nutrition, healthy people aged 18-50
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The high PUFA diet groupOther
Assumptions of nutritional intervention: in a randomized manner volunteers will be assigned to one of two groups: a control group which will receive general nutritional recommendations, based on the Polish nutrition pyramid, and the intervention group which will receive nutritional recommendations, based on the Polish nutrition pyramid and will consume at least 4 tablespoons of olive oil or 30 grams of nuts every day for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| The high PUFA diet group | Experimental | This will receive detailed nutritional recommendations and will consume at least 4 table spoons of olive oil or 30 grams of nuts daily for 12 weeks. Receives: Other: The high PUFA diet group |
| Control group | No intervention | The Control group will receive general nutritional recommendations based on Human Nutrition Recommendations for Polish Population. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutrient intake
Nutrient intake (3-day food records)
Measured: 12 weeks
Concentrations of lipoproteins and glucose
Serum concentrations of lipoproteins and glucose at baseline and after the intervention [mg/dl]
Measured: 12 weeks
Proteomic analysis of plasma
The aim is to identify biomarkers in the blood and to determine the differences between people from the control and the intervention group
Measured: 12 weeks
Metabolite concentrations in plasma
Metabolite concentrations in plasma samples are measured by high resolution mass spectrometry at baseline and after the intervention
Measured: 12 weeks
Secondary outcomes (5)
Body mass
body mass at baseline and after the intervention
Measured: 12 weeks
Height
height
Measured: 12 weeks
Percentage body fat
percentage body fat at baseline and after the intervention
Measured: 12 weeks
Waist circumference
waist circumference at baseline and after the intervention
Measured: 12 weeks
hip circumference
hip circumference at baseline and after the intervention
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start1 Jan 2019
- Primary completionApr 2019 (estimated)
- Study completionJun 2019 (estimated)
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poznan University of Life Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Agata Chmurzynska, PhD, Principal investigator, Poznan University of Life Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03892486
- Sponsor's protocol ID
- LKB 1249/19
- Status last verified
- Mar 2019
- First submitted
- 21 Feb 2019
- Last updated
- 27 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Effect of a Diet Enriched With Polyunsaturated Fatty Acids on the Proteomic and Metabolomic Profiles of Blood Plasma of Healthy People Aged 18-50
- ClinicalTrials.gov ID
- NCT03892486
- Acronym / sponsor ID
- LKB 1249/19
- Conditions
- Healthy
- Keywords
- metabolomics, proteomics, PUFA, nutrition, healthy people aged 18-50
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Poznan University of Life SciencesUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 27 Mar 2019 (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.
Analysis of the effect of dietary intervention based on increased polyunsaturated fatty acid intake on health. Specifically changes in blood lipid profile, as well as proteomic and metabolomic profiles of healthy adults will be analyzed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The high PUFA diet group | Experimental | Other: The high PUFA diet groupThis will receive detailed nutritional recommendations and will consume at least 4 table spoons of olive oil or 30 grams of nuts daily for 12 weeks. |
| Control group | No intervention | –The Control group will receive general nutritional recommendations based on Human Nutrition Recommendations for Polish Population. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- good health,
- proper body weight
- not meeting the needs for polyunsaturated fatty acids
Key exclusion criteria (7 listed)
- increased body weight,
- limited communication to an extent that makes it impossible to carry out a food interview,
- eating disorders (according to food history),
- metabolic diseases,
- pregnancy,
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 |
|---|---|---|
| The high PUFA diet groupAssumptions of nutritional intervention: in a randomized manner volunteers will be assigned to one of two groups: a control group which will receive general nutritional recommendations, based on the Polish nutrition pyramid, and the intervention group which will receive nutritional recommendations, based on the Polish nutrition pyramid and will consume at least 4 tablespoons of olive oil or 30 grams of nuts every day for 12 weeks. | Other | The high PUFA diet group |
Primary outcome
Nutrient intake
Time frame: 12 weeks
Nutrient intake (3-day food records)
Concentrations of lipoproteins and glucose
Time frame: 12 weeks
Serum concentrations of lipoproteins and glucose at baseline and after the intervention [mg/dl]
Proteomic analysis of plasma
Time frame: 12 weeks
The aim is to identify biomarkers in the blood and to determine the differences between people from the control and the intervention group
Metabolite concentrations in plasma
Time frame: 12 weeks
Metabolite concentrations in plasma samples are measured by high resolution mass spectrometry at baseline and after the intervention
5 secondary outcomes
Body mass
Time frame: 12 weeks
Height
Time frame: 12 weeks
Percentage body fat
Time frame: 12 weeks
Waist circumference
Time frame: 12 weeks
hip circumference
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2019.
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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.
Agata Chmurzynska, PhD principal investigator
Poznan University of Life Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The high PUFA diet group in people with Healthy, run by Poznan University of Life Sciences at 1 site in Poland.
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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 27 Mar 2019. 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 Poland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joanna Ciborska, Ph.D (+48 664 985 896, joanna.ciborska@uwm.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nutrient intake (time frame: 12 weeks). 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 27 Mar 2019.