Improvement of glucose homeostasis
Conditions
Interventions
Group 1: Calanusoil, (4 capsules), 2 gr/daily, for 12 weeks, (voluntary intake of calanus oil capsules for further 12 weeks as follow-up examination)
Group 2: Calanusoil, (8 capsules), 4 gr/daily, for
Sponsors
Gottfried Wilhelm Leibniz Universität HannoverInstitut für Lebensmittelwissenschaft und Humanernährung
Eligibility
Sex/Gender
All
Age
30 Years to 75 Years
Inclusion criteria
Inclusion criteria: - Age: 30-75 years (half men and half women) - Abdominal obesity (BMI > 28 kg/m2, waist circumference women =88 cm and men =102 cm - low fish/ long-chain omega-3 status (screened by questionnaire) - Willingness to take part on the whole study procedure - Willingness to take the capsules over 12 weeks
Exclusion criteria
Exclusion criteria: - Severe chronic diseases (i.e., diagnosed diabetes, cardiovascular disease, liver disease, renal insufficiency, cancer) - Chronic diseases involving the immune system (i.e., Crohn’s disease, colitis ulcerosa, rheumatoid arthritis, multiple sclerosis) - Use of any medication and food ingredients affecting blood glucose control and insulin sensitivity (including isolated dietary fiber such as guar gum, pectins, psyllium) - consumption of omega-3 fatty acid supplements - Permanent use of immunosuppressive drugs (corticoids etc.) - Anticoagulant drugs (e.g., Macumar) - Abuse of alcohol and drugs - Participation in another clinical study within the last 30 days - Pregnancy - Hypertonia: > 160 mmHg systolic blood pressure and > 100 mmHg diastolic blood pressure - Planned operation in the next 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Homeostatic Model Assessment for Insulin Resistance | — |
Secondary
| Measure | Time frame |
|---|---|
| - Fasting glucose - Fasting insulin - QUICKI (Quantitative Insulin Sensitivity Check Index) - HbA1c - Inflammatory parameters (hsCRP, TNFa, IL-1-ß, IL-6, MCP-1, IL-18, IL-10, INFLA-score). - Specialised Pro-Resolving Mediators (SPM) - TG, LDL, HDL, total cholesterol - Omega-3 index - Blood count - Blood pressure - Arterial stiffness via carotid-femoral pulse wave velocity (PWV) - Echocardiography - Safety parameters (creatinine, GOT, GPT, PT/INR (bleeding time)). - Dietary habits: (Food Frequency Questionnaire (FFQ)) - Anthropometric measurements: Weight, height, BMI, waist and hip circumference, bioelectrical impedance analysis. - Socio-demographic parameters: Age, gender, school-leaving qualification, occupation, marital status. - Other parameters: Smoking, intake of medication and food supplements, SF 36 (quality of life), Freiburg questionnaire, MEQ and MCTQ (chronotype), PSQI (sleep quality). - Gut microbiome analysis | — |
Countries
Germany
Contacts
Public ContactFelix Kerlikowsky
Gottfried Wilhelm Leibniz Universität HannoverInstitut für Lebensmittelwissenschaft und Humanernährung
Outcome results
None listed