E78.2
Conditions
Interventions
Group 1: food supplement
The food supplement investigated in this study contains L-arginine in combination with L-citrulline and micronutrients for the endothelial nitric oxide synthase enzyme system
Sponsors
RFB Healthcare GmbH
Eligibility
Sex/Gender
All
Age
45 Years to 85 Years
Inclusion criteria
Inclusion criteria: - Visceral obesity (waist circumference for men > 102 cm, for women > 88 cm) - Body mass index (BMI) = 28 kg/m2 - Dyslipidaemia (fasting triglycerides = 150 mg/dl, by blood test at screening visit) - 45 years of age and older - Signed informed consent
Exclusion criteria
Exclusion criteria: - Current treatment with statins or fibrates for dyslipidaemia - Intake of further food supplements or foods for special medical purposes (balanced diets) currently or during the last two weeks before study participation, except for calcium and vitamin D - Myocardial symptoms after light physical exertion - Current malignant disease - Acute systemic processes - Psychiatric disease - Pregnancy - Over 85 years of age - Participation in another study - Intolerance to any of the tested products consumed - Long-term or acute systemic treatment with corticosteroids
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fasting triglyceride levels in blood A blood sample will be taken at the screening visit and at visit 3 for analysis. Change from screening to Visit 3 (end of intake) will be compared. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Systolic and diastolic blood pressure - Complete blood count (erythrocytes, leukocytes [i.e., neutrophil, eosinophil and basophil granulocytes, monocytes, lymphocytes], thrombocytes, haemoglobin, haematocrit, MCH [mean corpuscular haemoglobin], MCV [mean corpuscular volume], MCHC [mean corpuscular haemoglobin concentration]) - LDL, HDL, total cholesterol - Glutamate pyruvate transferase (GPT) - ?-glutamyl transferase (?-GT) - Fasting insulin - Fasting glucose in blood and Homeostasis Model Assessment (HOMA calculated) - Further laboratory parameters as far as feasible, namely: HbA1c, bilirubin (total), glutamate oxalacetate transaminase (GOT), prothrombin time (Quick), LDH, creatinine, uric acid, free serum iron, albumin, thyroid-stimulating hormone (TSH), and highsensitive C-reactive protein (hsCRP) - General wellbeing (physical performance and psychological stability) as reported by the subjects using two questionnaires - Relevant health condition observed during the study For all outcomes, changes from screening to Visit 3 (end of intake) will be compared. | — |
Countries
Germany
Contacts
Public ContactWolfgang Rüdiger
RFB Healthcare GmbH
Outcome results
None listed