Nutrient deficiency healthy subjects
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Consenting independent/independent living men and women. - Age: 70 years and older - BMI 23.0 - 34.9 kg/m² - Mixed diet - no intake of dietary supplements for at least 3 months - written consent of the subjects after detailed verbal and written information about the study contents, requirements and risks
Exclusion criteria
Exclusion criteria: - known immunological diseases (e.g. autoimmune diseases) - permanent use of immunosuppressive drugs (cortisone, anti-inflammatory drugs, non-steroidal anti-inflammatory drugs, etc.) - alcohol, drug and/or medication addiction - noncompliant volunteers - Refusal or withdrawal of consent by the proband - Simultaneous participation in another clinical trial or participation within the last 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the nutritional status of active, healthy, unsupplemented, independently living older people. In addition to assessing the status of selected nutrients, the aim is to investigate whether this population could benefit from taking a multi-nutrient supplement in terms of nutrient status, metabolic parameters and immune function. | — |
Secondary
| Measure | Time frame |
|---|---|
| Laboratory chemical parameters for immune function: - (hs-)CRP in plasma - selected cytokines (TNFa, TGF-ß, IL-2, IL-6 and IL-10) in plasma and cell supernatant after ex vivo immune cell stimulation by LPS - Naive T cells - senescent T cells (TEMRA cells) - CD4/CD8 T-cell ratio - Number of regulatory T-cells - CD28 T cells (surface molecule on CD8 cells) - Neutrophil-to-lymphocyte ratio (NLR) - Platelet-to-lymphocyte ratio (PLR) - Systemic Immune Inflammation Index (SII) - Cytomegalovirus (CMV) Laboratory chemical parameters: - CBC - Serum Albumin - Total protein in serum - 25-OH-Vitamin D - Folic acid in serum - methylmalonic acid (MMA) - Homocysteine - vitamin B1 - vitamin B2 - vitamin B12 - Holo-TC - Iron, transferrin, ferritin - Zinc in plasma - Amino acid profile, ADMA - Malondialdehyde (MDA) - fasting glucose, insulin, HbA1c, HOMA - Triglycerides, total cholesterol, LDL cholesterol, HDL cholesterol - Omega-3 Index (relative content of EPA and DHA in erythrocyte membranes) - Liver enzymes: ALT, AST, gamma-GT - creatinine, uric acid - Intestinal microbiota composition Anthropometry, body functions: - Anthropometric parameters (height, weight, BMI, body measurements: upper arm circumference, abdominal circumference, waist circumference, calf circumference) - Bioelectric impedance analysis - Arterial stiffness using pulse wave velocity - Blood pressure - Frailty Index to Rockwood Supply of micronutrients, state of health and well-being: - Food Frequency Questionnaire (FFQ): Frequency of consumption of food groups (e.g. fruit, vegetables, red meat, wholemeal products etc.) - 3-day dietary protocol - Questions about the current health status (e.g. cold symptoms, fatigue, weakness, headaches), digestion and intestinal function and the intake of medication - Questionnaire Short Form 36 (SF-36) to record the health-related quality of life (=well-being) | — |
Countries
Germany
Contacts
Institut für Lebensmittelwissenschaft und Humanernährung