To compare the plasma concentration versus time profiles and postprandial bioavailability of DHA and EPA after a nutritionally relevant oral dose of 1.1 gram (expressed as DHA + EPA) administered as either CCx gelatin-based soft chews (emulsified)…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Nutritionele status (en dus preventief)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the sum of EPA and DHA plasma levels in venous
blood samples collected at baseline (t=-15min and 0) and at t=30, 60, 90, 120,
150, 180, 240, 360, 540, and 720min (obtained from cannula) and 24hours
(obtained via vena punction) after consumption of the different fish oil
supplements.
Secondary outcome
NA
Background summary
Marine omega-3 triglyceride oils, rich in eicosapentaenoic acid (EPA) and
docosahexaenoic acid (DHA), are widely consumed as nutraceutical supplements
due to their health benefits, such as improved cardiovascular health and
reduced inflammation. The demand for these omega-3-rich oils as food
supplements is increasing. However, studies indicate that the bioavailability
of these oils may be higher in emulsified forms compared to bulk oils like
those found in soft-gel capsules.
Study objective
To compare the plasma concentration versus time profiles and postprandial
bioavailability of DHA and EPA after a nutritionally relevant oral dose of 1.1
gram (expressed as DHA + EPA) administered as either CCx gelatin-based soft
chews (emulsified) or conventional gelatin-based soft gel capsules (bulk oil),
both containing an identical omega-3 enriched fish oil, in healthy adults.
Study design
This intervention study has a randomized, cross-over, open label design
Intervention
Intervention: Study subjects will receive one of the 2 fish oil supplements in
a randomized order
Study burden and risks
There are minor risks for the study subjects in this study. There are no direct
benefits for the study subjects. In this research, we include healthy subjects
based on the research criteria and a health questionnaire. The total amount of
blood taken (170mL) is spread over two weeks, and individuals with anemia are
excluded. Therefore, blood collection is not expected to pose any issues. Study
subjects involved in the study will invest approximately 28.5 hours in the
study. This study provides more insight into the effect of the formulation of
fish oil supplements and in particular the effect of emulsified fish oil on the
oral absorption of EPA and DHA. These findings can support the production and
development of better alternatives for EPA and DHA supplementation.
Brynsveien 11
Oslo 0667
NO
Brynsveien 11
Oslo 0667
NO
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
- Apparently healthy adults (18 - 50 yrs);
- Body mass index (BMI) >=18.5 and <=30 kg/m2;
- Having veins suitable for blood sampling via a catheter (judged by study
nurse/ medical doctor);
- Willing to refrain from fish, fish oil, and products with added omega-3
starting from 2 weeks prior to the first postprandial test day;
- Willing to keep a stable dietary pattern throughout the study.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- Having a disease that may interfere with the outcomes of this study, such as
a known metabolic, gastrointestinal, inflammatory or chronic disease (such as
anaemia, diabetes, hepatitis, hypercholesterolemia, cardiovascular disease), as
judged by the medical investigator;
- Having a history of medical or surgical events that may significantly affect
the study outcome, including: inflammatory bowel disease, pancreatitis, ulcers,
gastrointestinal or rectal bleeding; major gastrointestinal tract surgery such
as gastrectomy, gastroenterostomy, or bowel resection; known or suspected
gastrointestinal disorders, colon or GI tract cancer;
- Use of medication that may interfere with the study outcomes, including
gastric acid inhibitors, laxatives, and lipid lowering drugs, as judged by the
medical supervisor;
- Anaemia (Haemoglobin (Hb) values <7.5 mmol/L for women and <8.5 mmol/L for
men), as assessed by finger prick blood during screening visit;
- Allergic for fish;
- Having swallowing problems with capsules;
- Recent blood donation (<1 month prior to test day 1 of the study) or not
willing to stop donation during and 1 month after the study;
- Average alcohol intake >21 (women) or >28 (men) glasses of alcoholic
beverages per week;
- Reported to follow or having planned a slimming or medically prescribed diet;
- Use of recreational drugs;
- Current smokers, or stopped smoking in the last 3 months before study start;
- Insufficient proficiency in Dutch to understand information brochure and
questionnaires
- Participation in any clinical trial including blood sampling and/or
administration of substances up to 30 days before test day 1 of this study and
during the study period;
- Being an employee of the department Food, Health & Consumer Research
Wageningen Food & Biobased Research.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL87485.041.24 |
| Other | Volgt nog (ClinicalTrials.gov) |