Healthy Subjects
Conditions
Interventions
Group 1: NutrL-c01-high, administered once daily as a powder dissolved in water for 4 weeks
Group 2: NutrL-c01-low for 4 weeks
Group 3: placebo for 4 weeks
Sponsors
Chief Executive Officer, NutriLeads B.V.
Eligibility
Sex/Gender
All
Age
20 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Apparently healthy, Caucasian, males and females, aged 20–65 years at study start 2.BMI of 18.5 to 29.9 kg/m2 3.No disorders that may interfere with the study conduct or evaluation, e.g. current or previous respiratory, cardiovascular or metabolic diseases, chronic (auto)-immune, gastrointestinal disorders, infections etc. 4.Values within the normal reference range at V1 of leucocytes, lymphocytes and monocytes 5.No clinically relevant deviations and/or no deviations > 2 x ULN (upper limit of normal) in other laboratory values at V1 6.Readiness to comply with all specific study procedures, in particular: – Consumption of the investigational product (IP) during the entire study – Maintaining the habitual diet, with the exception regarding the required dietary restrictions throughout the study to be complied with – Accepting the collection of fecal samples – Accepting blood draws to evaluate immune response – Filling in health questionnaires 7.Women of childbearing potential only: Negative pregnancy testing (ß-HCG (beta subunit of human chorionic gonadotropin) test in urine) at V1 and readiness to use reliable contraception methods for the trial duration Prerequisite for the participation in the study is a written informed consent by the participant following written and oral information by the investigator regarding nature, purpose, possible benefit and possible risks of the clinical study.
Exclusion criteria
Exclusion criteria: 1.Previously known hypersensitivity to any component of the investigational product and/or to the source crop for NutrL-c01 2.Known severe acute or chronic immunological disorders such as acquired immune deficiency syndrome (AIDS) (or human immunodeficiency virus (HIV) positive) 3.Malignant disease within the last 5 years prior to V1 4.Known diagnosed allergies (including any food allergy) 5.Untreated or unstable hypertension (>140/90 mmHg) 6.Mastopathy and/or menstrual disorders 7.Any surgery or vaccination within the last 3 months prior to V1 and during the study 8.Intake of antibiotics, systemic corticosteroids, immune-suppressants, psychotherapeutic treatment that may effect the blood count within the last 3 months prior to V1 (except for nonsteroidal anti-inflammatory drugs and other potentially anti-inflammatory local analgesics =2 days prior to V1) and during study and/or intake of any treatment and/or supplementation influencing the immune system during the study (except for nonsteroidal anti-inflammatory drugs and other potentially anti-inflammatory analgesics =2 days prior to V2, V3 and V4) 9.Regular use of statins 10.Reported, unexplainable weight loss or gain >2 kg in the last month before V1 11.Intense sporting activities >10 h/week before V1 and during the study 12.Participation in night shift work or reported irregular sleep-wake pattern 2 weeks before V1 and during the study 13.Reported dietary restrictions such as consuming a medically prescribed diet, slimming diet or vegetarian diet in the last 3 months prior to V1 or during the study 14.Reported total consumption of >10 units (tablets, capsules, sachets etc.) of vitamin supplements containing ß-carotene, vitamin C, E or zinc in the last 3 months prior to V1 or any such supplementation during the study 15.Reported consumption of probiotic foods or drinks in the last month prior to V1 or during the study 16.Reported alcohol consumption of >2 units/day (1 unit equals approximately 250 mL of beer, 100 mL of wine or 35 mL of spirits) 17.Reported history of abuse of drugs or medication in the last 6 months prior to V1 18.Regular consumption of tobacco 19.Blood donation or transfusion in the last 2 months prior to V1 or during the study 20.Participation in another study in the last 2 months before V1 or during the study 21.Participation in the present study of a person living in the same household as the subject 22.Plans to travel abroad during the period of the entire study 23.Inability to comply with study procedures (e.g. due to language difficulties etc.) 24.Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Natural Killer cell activity, percent specific cytotoxicity for the different effector to target cell ratios (12:5:1, 25:1 and 50:1) at day 0 (visit 2), 5 (visit 3) and 28 (visit 4). Phagocytosis test, percentage of granulocytes and monocytes that performed phagocytosis as well as the mean fluorescence intensity (number of ingested bacteria) geometric mean (GeoMean FL1) for the granulocytes and monocytes at day 0 (visit 2), 5 (visit 3) and 28 (visit 4). And assess ex-vivo responses of blood cells measure by Interleukin 6 in pg/mL at day 0 (visit 2), 5 (visit 3) and 28 (visit 4) | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in transcriptome, differences in gene expression of peripheral blood mononuclear cell, at day 0 (visit 2), 5 (visit 3) and 28 (visit 4). Changes in secretome, differences in secreted factors of peripheral blood mononuclear cell, at day 0 (visit 2), 5 (visit 3) and 28 (visit 4). Changes in epigenome, gene activaction status of peripheral blood mononuclear cell, at day 0 (visit 2), 5 (visit 3) and 28 (visit 4). Perceived health and well being (questionannaire) day 0 (visit 2) and 28 (visit 4). | — |
Countries
Germany
Contacts
Public ContactRuud Albers
Chief Executive Officer, NutriLeads B.V.
Outcome results
None listed