The goal is to study whther the daily intake of consumer foods enriched with fish oil or seaweed extracts influences mood, mental capacity or antioxidant status in healthy subjects.
ID
Source
Brief title
Condition
- Other condition
- Lifestyle issues
Synonym
Health condition
cognitie en stemming
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Oxidative stress in plasma
Serum Clinical Chemical profile
Oxidative stress in (24h)-urine
Absorption of fatty acids
Cognitive performance
Secondary outcome
n/a
Background summary
Ingredients in fish oil as well in seaweed may have beneficial effects on
health and thinking ability. Omega-3 from fish oil, and seaweed extracts are
added to food in this study. Earlier studies on the effect of omega-3 have
shown favorable results in terms of attention, cognition and mood. Seaweed
(Fucus vesiculosus) contains compounds with potential anti-oxidant and
anti-inflammatory effect. Positive effects of daily consumption of foods
enriched with these components are not expected on cognition, mood and
parameters of oxidative stress.
Study objective
The goal is to study whther the daily intake of consumer foods enriched with
fish oil or seaweed extracts influences mood, mental capacity or antioxidant
status in healthy subjects.
Study design
A double blind randomized placebo-controlled trial. The duration of the
intervention period will be 10 weeks. The intervention period is preceded and
followed by a baseline and endpoint measure
Intervention
The study covers a period of 10 weeks, during which daily dairy product and a
grain product is consumed. There are three conditions:
an omega-3 dairy product + placebo cereal product
placebo dairy product + seaweed cereal product
placebo dairy product + placebo cereal product
Study burden and risks
Participation in the study can (optionally) give the following discomforts:
1. Three fasting blood collection
2. Collect twice 24-hour urine
3. Fill out a questionnaire for the assessment (Health and lifestyle
questionnaire)
4. Come to the research center, 1 time for testing and 2 times for the study,
nine times to pick up foods
5. Daily intake of food for 10 weeks
6. Keeping the daily diary for 10 weeks
7. Do twice cognitive testing on the computer
Subjects to their normal lifestyle and eating patterns persist, but use of
NSAIDs and paracetamol should be limited.
the day prior to each test day:
1. You should not use coffee, alcohol, acetaminophen or NSAIDs
2. From 22:00 in the evening, do not eat or drink (water is allowed)
Vinlandsleid 12
Reykjavik 113
IS
Vinlandsleid 12
Reykjavik 113
IS
Listed location countries
Age
Inclusion criteria
1. Age 18-70 yr; preferably 35 - 70
2. BMI > 20 kg/m2 and < 40 kg/m2 (preferably 25 - 32 ) and waist circumference > 80 cm (women) or > 94 cm (men)
3. Healthy as assessed by the independent physician based on medical history and values of total cholesterol, CRP, triglycerides and glucose
4. Voluntary participation
5. Having given written informed consent
6. Willing to comply with the study procedures
7. Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data for at least 15 years
8. Willing to accept the disclosure of the financial benefit of participation in the study to the authorities concerned.
Exclusion criteria
1. Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study or any non-invasive clinical trial up to 30 days before Day 01 of this study.
2. Having a history of medical or surgical events/ailments/treatments that may significantly affect the study outcome, including psychiatric disorders
3. Mental status that is incompatible with the proper conduct of the study
4. Known allergy or intolerance to food products, especially cereal, dairy and fish products
5. Use of dietary supplements
6. Smoking
7. Being colourblind
8. Alcohol consumption > 28 units/week for males and > 21 units/week for females
9. Reported slimming or medically prescribed diet
10. Personnel of CRO, their partner and their first and second degree relatives
11. Not having a general practitioner
12. Not willing to accept information-transfer concerning participation in the study, or information regarding his/her health, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from his general practitioner.
13. Pregnant or lactating or wishing to become pregnant in the period of the study
14. Extreme physical activity (more than 6h/week)
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 | NL48252.028.14 |