Bioavailability and physiological effects of nutrients in healthy subjects Nutritional, Metabolic, Endocrine
Conditions
Interventions
This observational study will include dietary supplementation. Therefore study subjects will be allocated to twelve different dietary supplementation groups (30 subjects per group).
Product formulati
Sponsors
Lycotec Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. All study participants should be healthy Caucasian males and females, age 20–80 2. Female subjects of childbearing potential should agree to undergo pregnancy tests and to use an appropriate method of contraception (i.e. oral contraceptive steroids, intrauterine device, barrier method) 3. All study participants should have findings within the normal range in medical history, physical examination, and relevant laboratory tests 4. All study participants should agree to undergo a pre-study physical examination and laboratory investigations 5. All study participants should be able to comprehend and willing to sign both statements of informed consent (for screening and phase-related procedures) 6. Only non-smokers or mild to moderate smokers (less than 10 cigarettes per day) should be enrolled in the study
Exclusion criteria
Exclusion criteria: The exclusion criteria (subjects who meet any of the following criteria are to be excluded from participating in the study): 1. The presence of a psychiatric disorder, antagonistic personality, poor motivation, emotional or intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with protocol requirements 2. History of or current compulsive alcohol abuse (> 10 drinks weekly), or regular exposure to other substances of abuse 3. Participation in another study with an experimental drug within 4 weeks before the initiation of the proposed dietary study 4. A major illness within 3 months before commencement of the screening period 5. History of hypersensitivity to food ingredients 6. History of bronchial asthma 7. Donation or loss of blood equal to or exceeding 500 ml during the 8 weeks before the initiation of the proposed dietary study or donation or loss blood from 250 to 500 ml in the 6 weeks before the initiation of the proposed dietary study or donation or loss of blood up to 250 ml in the 4 weeks before the initiation of the proposed dietary study 8. Resting heart rate of over 100 beats per minute or below 45 beats per minute during the screening period, either supine or standing 9. Positive testing for HIV or hepatitis B antigens 10. History of epilepsy 11. Difficulty fasting or consuming the standard meals 12. Subjects who do not tolerate venipuncture 13. Subjects on a special diet (e. g. liquid, protein, raw food diet) within 4 weeks before the initiation of the proposed dietary study 14. Drug addiction requiring treatment in the past 12 months 15. Subjects who do not agree to fully participate in wash-out period and exclude from the diet the recommended food for 4 weeks before the initiation of the study and during the study
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Comparative bioavailability assessment of the same group of dietary supplements comprising carotenoids, flavanols, resveratrol, omega 3 fatty acids etc as well as their combinations at different doses in different food matrices, such as chocolate, butter and vegetable oils 2. Assessment of dietary supplement effects on the characteristics of the facial skin of trial participants 3. Assessment of dietary supplement effects on the characteristics of the cerumen (ear wax) of trial participants 4. Assessment of dietary supplement effects on the lipid association with conjunctival epithelium cells in the tear fluid of trial participants These secondary outcome measures will be determined by comparing results obtained for samples collected before trial (time point 0) with the final time point of the study (following 8 weeks of food supplement consumption). | — |
Primary
| Measure | Time frame |
|---|---|
| The principal objective of this research project is to assess bioavailability of a range of dietary supplements comprising carotenoids, flavanols, resveratrol, omega 3 fatty acids etc as well as their combinations in different food matrices, such as chocolate, butter and vegetable oils. Results on supplement bioavailability will constitute primary outcome measures which will be based upon analysing blood samples obtained at day 1 (postprandial) and following weeks 1, 2, 3, 4, 6, and 8 of the trial. All these results will be compared to individual pre-trial results (time point 0). | — |
Countries
England, United Kingdom
Outcome results
None listed