Effect of Calanus oil on glucose homeostasis insubjects with abdominal obesity
- Conditions
- Improvement of glucose homeostasis
- Registration Number
- DRKS00030256
- Lead Sponsor
- Gottfried Wilhelm Leibniz Universität HannoverInstitut für Lebensmittelwissenschaft und Humanernährung
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 280
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
- 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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Homeostatic Model Assessment for Insulin Resistance
- Secondary Outcome Measures
Name Time Method - Fasting glucose<br>- Fasting insulin<br>- QUICKI (Quantitative Insulin Sensitivity Check Index)<br>- HbA1c<br>- Inflammatory parameters (hsCRP, TNFa, IL-1-ß, IL-6, MCP-1, IL-18, IL-10).<br>- Specialised Pro-Resolving Mediators (SPM)<br>- TG, LDL, HDL, total cholesterol<br>- Omega-3 index<br>- Blood count<br>- Blood pressure<br>- Arterial stiffness via carotid-femoral pulse wave velocity (PWV)<br>- Echocardiography<br>- Safety parameters (creatinine, GOT, GPT, PT/INR (bleeding time)).<br>- Dietary habits: Food Frequency Questionnaire (FFQ)<br>- Anthropometric measurements: Weight, height, BMI, waist and hip circumference, bioelectrical impedance analysis.<br>- Socio-demographic parameters: Age, gender, school-leaving qualification, occupation, marital status.<br>- Other parameters: Smoking, intake of medication and food supplements, SF 36 (quality of life), Freiburg questionnaire.