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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05427604
• Other study ID #: Omegaserum
• Status: Completed
• Phase: N/A
• Start date: February 23, 2021
• Est. completion date: June 21, 2021

Study information

• Verified date: June 2022
• Source: Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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 1. determination of the time when a maximum concentration of fatty acids is observed in the serum after ingestion of olive oil (the control condition) 2. blood sampling at baseline (fasting) and at Tmax after olive oil ingestion 3. 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) 4. blood sampling at baseline (fasting) and at Tmax after ingestion of DHA-enriched oil.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: June 21, 2021
• Est. primary completion date: June 21, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Olive oil
ingestion of olive oil (3g) and blood measurement at baseline, after 1h, 2h, 3h, 4h, 5h, 6h
• Olive Oil
ingestion of olive oil (3g) and blood sampling at the fatty acids pic concentration (for in vitro study)
• DHA oil
ingestion of DHA oil (3g) and blood measurement at baseline, after 1h, 2h, 3h, 4h, 5h, 6h
• DHA oil
ingestion of DHA oil (3g) and blood sampling at the fatty acids pic concentration (for in vitro study)

Locations

Country	Name	City	State
Belgium	UCLouvain - CICN	Louvain-La-Neuve

Sponsors (1)

Lead Sponsor	Collaborator
Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Palmitoleic fatty acid pattern	Area under the curve of palmitoleic fatty acid in serum calculated during 6 hours post-ingestion	through study completion, an average of 4 months
Primary	Docosahexaenoic fatty acid pattern	Area under the curve of docosahexaenoic acid in serum calculated during 6 hours post-ingestion	through study completion, an average of 4 months