HealthyNCT05427604
To Evaluate the Effects of Omega 3 Fatty Acids in the Context of Cancer Prevention
A study testing Olive oil and DHA oil in people with Healthy, run by Université Catholique de Louvain at 1 site in Belgium.
Trial summary
Previous studies have demonstrated, in an in vitro micro-tumour model (the spheroid) and in a mouse model, that long-chain omega-3 fatty acids, in particular docosahexaenoic acid (DHA), can inhibit tumour development. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Olive oil and DHA oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteBelgium
- Study dates
- 23 Feb 2021to 21 Jun 2021
- 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
- Woman or man, aged of 18 to 65 years;
- Body mass index between 20 and 30 kg/m2;
- For women: use of effective contraception;
- Provision of signed and dated informed consent form;
- Stated willingness to comply with all study procedures and availability for the duration of the study.
Who cannot join
- Uncontrolled systolic blood pressure > 160/100 mmHg;
- For premenopausal women: pregnant women or women planning to get pregnant within 3 months or lactating women;
- For menopausal women: less than 6 months of menopause;
- Type II diabetes (controlled or uncontrolled), Type I diabetes;
- Medical history or actual severe psychiatric, severe neurologic, severe hepatic, severe pancreatic, severe kidney, severe pulmonary, severe cardiovascular or severe gastrointestinal problem;
- Thyroid disorder;
Show all 14Show fewer
- Cancer < 3 years before the inclusion;
- Consumption of drug under prescription or over-the-counter drug or dietary supplement (including n-3 PUFA) within 1 month before the inclusion (excepted contraception);
- Consumption of fish or of omega-3 enriched eggs > 2 times per week within 1 month before the inclusion;
- Subjects who are not able to understand and follow study procedures;
- Drug addiction problem (occasional or regular consumption);
- Women who drink more than 2 glasses of alcohol per day (> 20 g of alcohol per day or > 140 g/week) or men who drink more than 3 glasses of alcohol per day (> 30 g of alcohol per day or more than 210 g/week);
- Subjects having given their blood within less than 3 months before inclusion;
- Subjects having participated to another clinical trial with an investigational product within less than 1 month before the inclusion.
Trial locations and contacts
1 site in 1 country.
About this study
Previous studies have demonstrated, in an in vitro micro-tumour model (the spheroid) and in a mouse model, that long-chain omega-3 fatty acids, in particular docosahexaenoic acid (DHA), can inhibit tumour development.
Therefore, the aim of this study was to collect DHA-enriched human serum, following ingestion of a DHA-enriched oil, in order to assess its effect on tumour development in vitro. Blood enriched in fatty acids not containing DHA will be used as a control condition, obtained after ingestion of olive oil.
This study is an important step to determine the interest of DHA supplementation as a new approach to prevent tumour development, and/or as an adjuvant to cancer treatments.
Read the detailed description
The objective of this study is to collect DHA-enriched human serum in order to test it on the in vitro tumour model, spheroids. The results will be compared with human serum enriched in fatty acids (saturated, monounsaturated and polyunsaturated) but not in DHA.
To do this, the study will be divided into 4 steps
- determination of the time when a maximum concentration of fatty acids is observed in the serum after ingestion of olive oil (the control condition)
- blood sampling at baseline (fasting) and at Tmax after olive oil ingestion
- determination of the time when a maximum concentration of fatty acids is observed in the serum after ingestion of DHA-enriched oil (the test condition)
- blood sampling at baseline (fasting) and at Tmax after ingestion of DHA-enriched oil.
- Conditions
- Healthy
- Being tested
- Olive oil, DHA oil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olive oilOther
ingestion of olive oil (3g) and blood measurement at baseline, after 1h, 2h, 3h, 4h, 5h, 6h
Olive OilOther
ingestion of olive oil (3g) and blood sampling at the fatty acids pic concentration (for in vitro study)
DHA oilOther
ingestion of DHA oil (3g) and blood measurement at baseline, after 1h, 2h, 3h, 4h, 5h, 6h
DHA oilOther
ingestion of DHA oil (3g) and blood sampling at the fatty acids pic concentration (for in vitro study)
| Study group | Role | What they receive |
|---|---|---|
| Sequential intervention | Other | 1. single ingestion of olive oil for assessement of monounsaturated fatty acids peak time in blood (3g)
2. single ingestion of olive oil for collection of blood sample at peak time (3g)
3. single ingestion of DHA-rich oil for assessement of polyunsaturated fatty acids peak time in blood (3g)
4. single ingestion of DHA-rich oil for collection of blood sample at peak time (3g) Receives: Other: Olive oil; Other: DHA oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Palmitoleic fatty acid pattern
Area under the curve of palmitoleic fatty acid in serum calculated during 6 hours post-ingestion
Measured: through study completion, an average of 4 months
Docosahexaenoic fatty acid pattern
Area under the curve of docosahexaenoic acid in serum calculated during 6 hours post-ingestion
Measured: through study completion, an average of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start23 Feb 2021
- Primary completion21 Jun 2021
- Study completion21 Jun 2021
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.
- More trials run by Université Catholique de LouvainThe 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05427604
- Sponsor's protocol ID
- Omegaserum
- Status last verified
- Jun 2022
- First submitted
- 30 May 2022
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Effects of Omega 3 Fatty Acids in the Context of Cancer Prevention
- ClinicalTrials.gov ID
- NCT05427604
- Acronym / sponsor ID
- Omegaserum
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 23 Feb 2021 (actual)
- Primary completion
- 21 Jun 2021 (actual)
- Study completion
- 21 Jun 2021 (actual)
- First posted
- 22 Jun 2022 (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.
Previous studies have demonstrated, in an in vitro micro-tumour model (the spheroid) and in a mouse model, that long-chain omega-3 fatty acids, in particular docosahexaenoic acid (DHA), can inhibit tumour development.
Therefore, the aim of this study was to collect DHA-enriched human serum, following ingestion of a DHA-enriched oil, in order to assess its effect on tumour development in vitro. Blood enriched in fatty acids not containing DHA will be used as a control condition, obtained after ingestion of olive oil.
This study is an important step to determine the interest of DHA supplementation as a new approach to prevent tumour development, and/or as an adjuvant to cancer treatments.
Detailed description
The objective of this study is to collect DHA-enriched human serum in order to test it on the in vitro tumour model, spheroids. The results will be compared with human serum enriched in fatty acids (saturated, monounsaturated and polyunsaturated) but not in DHA.
To do this, the study will be divided into 4 steps
- determination of the time when a maximum concentration of fatty acids is observed in the serum after ingestion of olive oil (the control condition)
- blood sampling at baseline (fasting) and at Tmax after olive oil ingestion
- determination of the time when a maximum concentration of fatty acids is observed in the serum after ingestion of DHA-enriched oil (the test condition)
- blood sampling at baseline (fasting) and at Tmax after ingestion of DHA-enriched oil.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sequential intervention | Other | Other: Olive oil, Other: DHA oil1. single ingestion of olive oil for assessement of monounsaturated fatty acids peak time in blood (3g) 2. single ingestion of olive oil for collection of blood sample at peak time (3g) 3. single ingestion of DHA-rich oil for assessement of polyunsaturated fatty acids peak time in blood (3g) 4. single ingestion of DHA-rich oil for collection of blood sample at peak time (3g) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Woman or man, aged of 18 to 65 years;
- Body mass index between 20 and 30 kg/m2;
- For women: use of effective contraception;
- Provision of signed and dated informed consent form;
- Stated willingness to comply with all study procedures and availability for the duration of the study.
Key exclusion criteria (14 listed)
- Uncontrolled systolic blood pressure > 160/100 mmHg;
- For premenopausal women: pregnant women or women planning to get pregnant within 3 months or lactating women;
- For menopausal women: less than 6 months of menopause;
- Type II diabetes (controlled or uncontrolled), Type I diabetes;
- Medical history or actual severe psychiatric, severe neurologic, severe hepatic, severe pancreatic, severe kidney, severe pulmonary, severe cardiovascular or severe gastrointestinal problem;
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 |
|---|---|---|
| Olive oilingestion of olive oil (3g) and blood measurement at baseline, after 1h, 2h, 3h, 4h, 5h, 6h | Other | Sequential intervention |
| Olive Oilingestion of olive oil (3g) and blood sampling at the fatty acids pic concentration (for in vitro study) | Other | Sequential intervention |
| DHA oilingestion of DHA oil (3g) and blood measurement at baseline, after 1h, 2h, 3h, 4h, 5h, 6h | Other | Sequential intervention |
| DHA oilingestion of DHA oil (3g) and blood sampling at the fatty acids pic concentration (for in vitro study) | Other | Sequential intervention |
Primary outcome
Palmitoleic fatty acid pattern
Time frame: through study completion, an average of 4 months
Area under the curve of palmitoleic fatty acid in serum calculated during 6 hours post-ingestion
Docosahexaenoic fatty acid pattern
Time frame: through study completion, an average of 4 months
Area under the curve of docosahexaenoic acid in serum calculated during 6 hours post-ingestion
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 22 Jun 2022.
- Individual participant dataSharing planned: No
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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.
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 Olive oil and DHA oil in people with Healthy, run by Université Catholique de Louvain at 1 site in Belgium.
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 5 inclusion and 14 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 22 Jun 2022. 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 Belgium. 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?
Palmitoleic fatty acid pattern (time frame: through study completion, an average of 4 months). The study lists 2 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 22 Jun 2022.