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Completed

NCT Number: NCT05427604

To Evaluate the Effects of Omega 3 Fatty Acids in the Context of Cancer Prevention

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCLouvain - CICN

Louvain-la-Neuve, 1348, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • 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.

Treatment and study plan

olive oil

Other

ingestion of olive oil (3g) and blood measurement at baseline, after 1h, 2h, 3h, 4h, 5h, 6h

DHA oil

Other

ingestion of DHA oil (3g) and blood measurement at baseline, after 1h, 2h, 3h, 4h, 5h, 6h

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Université Catholique de Louvain

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 22, 2022
Registry last updated
Jun 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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