NCT05427604

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 23, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 22, 2022

Completed
Last Updated

June 22, 2022

Status Verified

June 1, 2022

Enrollment Period

4 months

First QC Date

May 30, 2022

Last Update Submit

June 16, 2022

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (1)

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)

Other: Olive oilOther: DHA oil

Interventions

Olive OilOTHER

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

Sequential intervention
DHA oilOTHER

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

Sequential intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • 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);

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLouvain - CICN

Louvain-la-Neuve, 1348, Belgium

Location

MeSH Terms

Interventions

Olive Oil

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFats, UnsaturatedPlant OilsOilsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2022

First Posted

June 22, 2022

Study Start

February 23, 2021

Primary Completion

June 21, 2021

Study Completion

June 21, 2021

Last Updated

June 22, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)