Endogenous Conversion of Alpha Linolenic AcidKoALANCT03558776
Influence of the Background Diet on Metabolism of Land-based n-3 PUFA
A study testing linseed oil in people with Endogenous Conversion of Alpha Linolenic Acid, run by University of Jena at 1 site in Germany.
Trial summary
KoALA study - assessment of the influence of the background diet on the metabolism and the bioavailability of plant n-3 PUFA from linseed oil. In particular, the study design focusses on the impact of variations in the background diet as confounding factor (e.g. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Endogenous Conversion of Alpha Linolenic Acid
- What is being tested?
- linseed oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 148 participants
- Where
- 1 siteGermany
- Study dates
- 13 Mar 2018to 31 Dec 2018
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Whether participants meet the inclusion criteria will be evaluated by screening prior the run-in (blood sampling).
- Females (in the menopause) and males (50 % each); age: 40 - 65 years; BMI < 30 kg/m2
- Subjects must be able and willing to give written informed consent, and to comply with study procedures
- Subjects with moderate elevated LDL cholesterol (> 3 mmol/l), without lipid-lowering medication
- Persons who consume a traditional "Western diet" composed of meat, sausage, dairy products, cereals, vegetables, fruits etc.
- Precondition: stable eating habits at least one year before enrollment
- Subjects must have adequate fluency in the German language to complete the questionnaires and understand the daily menu plans
- No antihypertensive medication or stable dose for >3 months prior to start of the study and during the entire study period
Who cannot join
- Subjects with any acute or chronic disease (tumor, infection, other), gastrointestinal diseases, diabe-tes mellitus (type I and II), chronic renal disease, diseases of the parathyroids, diseases necessitat-ing regular phlebotomies other chronic diseases which could affect the results of the present study
- Use of medication which could affect the results of the present study including systemic glucocorti-coids, lipid-lowering medication
- Hormone replacement therapy
- Use of dietary supplements, incl. multivitamins, fish oil capsules, minerals, and trace elements (three months before and during the entire study period)
- Weight loss or weight gain (> 3 kg) during the last three months before study begin
- Relevant food allergies (e.g. milk, nuts etc.)
- Pregnancy or lactation
- Transfusion of blood in the last three months before blood sample taking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of the Background Diet on Metabolism of Land-based n-3 PUFA From Linseed Oil - Focus: Conversion of Alpha Linolenic Acid (ALA; KoALA Study)
KoALA study - assessment of the influence of the background diet on the metabolism and the bioavailability of plant n-3 PUFA from linseed oil.
In particular, the study design focusses on the impact of variations in the background diet as confounding factor (e.g. variations in concurrently intake of linoleic acid (n-6)). Further, the influence of a regular intake of milk fat, in particular from free-grazing ruminants, on n-3 PUFA metabolism will be investigated.
Read the detailed description
The KoALA study focuses on the impact of variations in the background diet as a confounding factor. The intake of linoleic acid (LA, C18:2 n-6) has been suggested to diminish the metabolism of α-linolenic acid (ALA, C18:3 n-3) to eicosapentaenoic acid (EPA, C20:5 n-3) and docosahexaenoic acid (DHA, 22:6 n-3).
In this context, the proposed study will be conducted to evaluate the influence of the background diet, in particular the impact of the simultaneous intake of LA on the conversion of ALA into their long-chain (LC) metabolites, the incorporation of n-3 LC-PUFA in human tissues and their metabolism into eicosanoids and docosanoids. Further, the influence of a regular intake of milk fat, in particular from free-grazing ruminants, on n-3 PUFA metabolism will be investigated, because short- and middle-chain fatty acids as well as the branched-chain fatty acids in milk fat may influence the conversion of ALA into n-3 LC-PUFA (hypothesis).
Thus, validated nutrition concepts for increasing n-3 LC-PUFA status from plant sources will be developed to ensure an adequate intake of n-3 PUFA according to the guidelines of nutritional societies and as a contribution to the prevention of cardiovascular diseases.
- Being tested
- linseed oil
- Keywords
- alpha linolenic acid, linseed oil, eicosapentaenoic acid, docosahexaenoic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
linseed oilDietary supplement
linseed oil and defined background diet
| Study group | Role | What they receive |
|---|---|---|
| Linseed oil plus defined background diet (high linolec acid) | Active comparator | Linseed oil (LO) plus daily menu plans (total dietary fat intake: 30 En%): 10 En% LO plus menu plan with 20 En% fat: A) 7 ± 2 En% linoleic acid (n = 37) Receives: Dietary Supplement: linseed oil |
| Linseed oil plus defined background diet (low linolec acid) | Active comparator | Linseed oil (LO) plus daily menu plans (total dietary fat intake: 30 En%): 10 En% LO plus menu plan with 20 En% fat: B) < 2.5 En% linoleic acid (n = 37) Receives: Dietary Supplement: linseed oil |
| Linseed oil plus defined background diet (high milk) | Active comparator | Linseed oil (LO) plus daily menu plans (total dietary fat intake: 30 En%): 10 En% LO plus menu plan with 20 En% fat: C) 15 ± 2 En% milk fat (n = 37) Receives: Dietary Supplement: linseed oil |
| Linseed oil without defined background diet | Placebo comparator | Linseed oil (LO) without defined menu plans (D) Western diet, n = 37) Receives: Dietary Supplement: linseed oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of EPA and further n-3 PUFA in plasma and erythrocyte lipids
Percentage of EPA and further n-3 PUFA (ALA, DPA, DHA) in plasma and erythrocyte lipids (available from the gas chromatographic analysis)
Measured: change from baseline after 4, 8 and 12 weeks
Secondary outcomes (10)
Fatty acid distribution in plasma lipids
Fatty acid distribution in plasma lipids (including SFA, MUFA, PUFA, > 90 fatty acids) available from the gas chromatographic analysis)
Measured: change from baseline after 4, 8 and 12 weeks
Fatty acid distribution in erythrocyte lipids
Fatty acid distribution in erythrocyte lipids (including SFA, MUFA, PUFA, > 90 fatty acids) available from the gas chromatographic analysis)
Measured: change from baseline after 4, 8 and 12 weeks
Anthropometric and physiological data
height, weight, blood pressure, bioelectrical impedance, waist circumstances, heart rate variability
Measured: change from baseline after 4, 8 and 12 weeks
Blood lipids
total cholesterol, LDL cholesterol, HDL cholesterol, triacylglycerides
Measured: change from baseline after 4, 8 and 12 weeks
Inflammatory markers
eicosanoids, docosanoids
Measured: change from baseline after 4, 8 and 12 weeks
Diabetes risk markers
Insulin, HbA1c, glucose
Measured: change from baseline after 4, 8 and 12 weeks
Clotting markers
alpha prothrombin time, fibrinogen
Measured: change from baseline after 4, 8 and 12 weeks
Cardiovascular risk factors
homocysteine; high sensitive c-reactive protein
Measured: change from baseline after 4, 8 and 12 weeks
Unbound free fatty acid profiles in plasma
Unbound free fatty acid profiles in plasma
Measured: change from baseline after 12 weeks
Futher biomarkers (cardovascular risk factors)
Cotinin (marker for smoking), Cystatin C (marker for kidney function), NT-pro-BNP (marker for cardiac function, volume regulation), Troponin (TnT or TnI, marker for myocardial necrosis), Galektin 3 (marker for fibrosis), Asymmetric dimethylarginine (ADMA), homoarginine, trimethylamine N-oxide (TMAO)
Measured: change from baseline after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start13 Mar 2018
- Primary completion22 Jul 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endogenous Conversion of Alpha Linolenic AcidStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Blood samples will be taken at the beginning and regularly every four weeks during the 12-weeks intervention period. For all groups, the consumption of additional n-3 PUFA sources is not permitted during the entire intervention period. The study intervention will consist of a daily dose of linseed oil (LO, 10 En%) and prepared daily menu plans determining the background diet, except for the control group D. The fat composition of the developed daily menu plans (fat content 20 En%) will differ between the groups A to C. For groups A to C, the daily menu plans will ensure an adequate intake of energy and nutrients according to the guidelines of the German Society of Nutrition. Group D serves as control because in this group the background diet is not fixed by menu plans. Participants of group D must follow their normal dietary habits, i.e. a typical Western diet (LA intake is about 15 g/d (5-7 En%) / SFA intake ranges from 10 to 15 En%).
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christine Dawczynski,PhD, University of Jena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03558776
- Sponsor's protocol ID
- H6_18
- Acronym
- KoALA
- Status last verified
- Jun 2018
- First submitted
- 5 Jun 2018
- Last updated
- 7 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: publication of the study data and results in national and international journals
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of the Background Diet on Metabolism of Land-based n-3 PUFA From Linseed Oil - Focus: Conversion of Alpha Linolenic Acid (ALA; KoALA Study)
- ClinicalTrials.gov ID
- NCT03558776
- Acronym / sponsor ID
- KoALA / H6_18
- Keywords
- alpha linolenic acid, linseed oil, eicosapentaenoic acid, docosahexaenoic acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- University of JenaUniversity, hospital or other
- Study start
- 13 Mar 2018 (actual)
- Primary completion
- 22 Jul 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 15 Jun 2018 (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.
KoALA study - assessment of the influence of the background diet on the metabolism and the bioavailability of plant n-3 PUFA from linseed oil.
In particular, the study design focusses on the impact of variations in the background diet as confounding factor (e.g. variations in concurrently intake of linoleic acid (n-6)). Further, the influence of a regular intake of milk fat, in particular from free-grazing ruminants, on n-3 PUFA metabolism will be investigated.
Detailed description
The KoALA study focuses on the impact of variations in the background diet as a confounding factor. The intake of linoleic acid (LA, C18:2 n-6) has been suggested to diminish the metabolism of α-linolenic acid (ALA, C18:3 n-3) to eicosapentaenoic acid (EPA, C20:5 n-3) and docosahexaenoic acid (DHA, 22:6 n-3).
In this context, the proposed study will be conducted to evaluate the influence of the background diet, in particular the impact of the simultaneous intake of LA on the conversion of ALA into their long-chain (LC) metabolites, the incorporation of n-3 LC-PUFA in human tissues and their metabolism into eicosanoids and docosanoids. Further, the influence of a regular intake of milk fat, in particular from free-grazing ruminants, on n-3 PUFA metabolism will be investigated, because short- and middle-chain fatty acids as well as the branched-chain fatty acids in milk fat may influence the conversion of ALA into n-3 LC-PUFA (hypothesis).
Thus, validated nutrition concepts for increasing n-3 LC-PUFA status from plant sources will be developed to ensure an adequate intake of n-3 PUFA according to the guidelines of nutritional societies and as a contribution to the prevention of cardiovascular diseases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Blood samples will be taken at the beginning and regularly every four weeks during the 12-weeks intervention period. For all groups, the consumption of additional n-3 PUFA sources is not permitted during the entire intervention period. The study intervention will consist of a daily dose of linseed oil (LO, 10 En%) and prepared daily menu plans determining the background diet, except for the control group D. The fat composition of the developed daily menu plans (fat content 20 En%) will differ between the groups A to C. For groups A to C, the daily menu plans will ensure an adequate intake of energy and nutrients according to the guidelines of the German Society of Nutrition. Group D serves as control because in this group the background diet is not fixed by menu plans. Participants of group D must follow their normal dietary habits, i.e. a typical Western diet (LA intake is about 15 g/d (5-7 En%) / SFA intake ranges from 10 to 15 En%).
| Arm | Type | Receives |
|---|---|---|
| Linseed oil plus defined background diet (high linolec acid) | Active comparator | Dietary Supplement: linseed oilLinseed oil (LO) plus daily menu plans (total dietary fat intake: 30 En%): 10 En% LO plus menu plan with 20 En% fat: A) 7 ± 2 En% linoleic acid (n = 37) |
| Linseed oil plus defined background diet (low linolec acid) | Active comparator | Dietary Supplement: linseed oilLinseed oil (LO) plus daily menu plans (total dietary fat intake: 30 En%): 10 En% LO plus menu plan with 20 En% fat: B) < 2.5 En% linoleic acid (n = 37) |
| Linseed oil plus defined background diet (high milk) | Active comparator | Dietary Supplement: linseed oilLinseed oil (LO) plus daily menu plans (total dietary fat intake: 30 En%): 10 En% LO plus menu plan with 20 En% fat: C) 15 ± 2 En% milk fat (n = 37) |
| Linseed oil without defined background diet | Placebo comparator | Dietary Supplement: linseed oilLinseed oil (LO) without defined menu plans (D) Western diet, n = 37) |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Whether participants meet the inclusion criteria will be evaluated by screening prior the run-in (blood sampling).
- Females (in the menopause) and males (50 % each); age: 40 - 65 years; BMI < 30 kg/m2
- Subjects must be able and willing to give written informed consent, and to comply with study procedures
- Subjects with moderate elevated LDL cholesterol (> 3 mmol/l), without lipid-lowering medication
- Persons who consume a traditional "Western diet" composed of meat, sausage, dairy products, cereals, vegetables, fruits etc.
Key exclusion criteria (8 listed)
- Subjects with any acute or chronic disease (tumor, infection, other), gastrointestinal diseases, diabe-tes mellitus (type I and II), chronic renal disease, diseases of the parathyroids, diseases necessitat-ing regular phlebotomies other chronic diseases which could affect the results of the present study
- Use of medication which could affect the results of the present study including systemic glucocorti-coids, lipid-lowering medication
- Hormone replacement therapy
- Use of dietary supplements, incl. multivitamins, fish oil capsules, minerals, and trace elements (three months before and during the entire study period)
- Weight loss or weight gain (> 3 kg) during the last three months before study begin
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 |
|---|---|---|
| linseed oillinseed oil and defined background diet | Dietary supplement | Linseed oil plus defined background diet (high linolec acid), Linseed oil plus defined background diet (high milk), Linseed oil plus defined background diet (low linolec acid), Linseed oil without defined background diet |
Primary outcome
Percentage of EPA and further n-3 PUFA in plasma and erythrocyte lipids
Time frame: change from baseline after 4, 8 and 12 weeks
Percentage of EPA and further n-3 PUFA (ALA, DPA, DHA) in plasma and erythrocyte lipids (available from the gas chromatographic analysis)
10 secondary outcomes
Fatty acid distribution in plasma lipids
Time frame: change from baseline after 4, 8 and 12 weeks
Fatty acid distribution in erythrocyte lipids
Time frame: change from baseline after 4, 8 and 12 weeks
Anthropometric and physiological data
Time frame: change from baseline after 4, 8 and 12 weeks
Blood lipids
Time frame: change from baseline after 4, 8 and 12 weeks
Inflammatory markers
Time frame: change from baseline after 4, 8 and 12 weeks
Diabetes risk markers
Time frame: change from baseline after 4, 8 and 12 weeks
Clotting markers
Time frame: change from baseline after 4, 8 and 12 weeks
Cardiovascular risk factors
Time frame: change from baseline after 4, 8 and 12 weeks
Unbound free fatty acid profiles in plasma
Time frame: change from baseline after 12 weeks
Futher biomarkers (cardovascular risk factors)
Time frame: change from baseline after 12 weeks
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 7 Mar 2019.
- Individual participant dataSharing planned: Undecided. publication of the study data and results in national and international journals
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing linseed oil in people with Endogenous Conversion of Alpha Linolenic Acid, run by University of Jena at 1 site in Germany.
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 8 inclusion and 8 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 7 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 Germany. 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. Some participants in this study may receive a placebo. 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?
Percentage of EPA and further n-3 PUFA in plasma and erythrocyte lipids (time frame: change from baseline after 4, 8 and 12 weeks). 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 7 Mar 2019.