The Nuts for LIFE (Lipids, InFlammation, Endothelial) Study: The dose-response effect of hazelnut consumption on blood lipids, inflammatory markers and endothelial function in overweight and obese individuals
Not Applicable
- Conditions
- Overweight / ObesityDiet and Nutrition - Obesity
- Registration Number
- ACTRN12610000285055
- Lead Sponsor
- niversity of Otago
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
The inclusion criteria are males and females aged between 18 and 65 years with a Body Mass Index (BMI) greater than or equal to 25 [weight (kg) / height (m2)]
Exclusion Criteria
The exclusion criteria are smokers. Pregnant or breastfeeding women. People who have asthma. People who are on weight loss programmes. People with food allergies or food aversions to nuts. People who have inflammatory diseases such as Crohn's or Celiac disease. People who have familial or secondary hyperlipidaemia or major chronic diseases such as cancer, heart disease or diabetes. People who are taking medication known to affect inflammatory markers, e.g. aspirin, ibuprofen, naproxen, glucocorticoids, etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Endothelial function. This will be measured by using a SphygmoCor system.[At baseline and at 12 weeks after intervention commencement];Inflammatory markers. Plasma high-sensitivity C-reactive protein (Hs-CRP) will be measured by using a Cobas Mira Plus Analyser. Plasma intracellular adhesion molecule-1 (ICAM-1), vascular cell adhesion molecule-1 (VCAM-1), interleukin-6 (IL-6) and tumour necrosis factor-alpha (TNF-alpha) will be measured by using Quantikine enzyme-linked immunosorbent assay (ELISA) Kits.[At baseline and at 6 and 12 weeks after intervention commencement];Plasma lipids and lipoproteins. Plasma total cholesterol, high density lipoprotein cholesterol (HDL-C) and triglyceride concentrations will be measured by enzymatic methods using a Cobas Mira Plus analyser. Plasma low density lipoprotein cholesterol (LDL-C) concentration will be calculated using the Friedewald formula.[At baseline and at 6 and 12 weeks after intervention commencement]
- Secondary Outcome Measures
Name Time Method Body composition. This will be measured by using a bioelectrical impedance analysis.[At baseline and at 6 and 12 weeks after intervention commencement];Oral fatty acid sensitivity. This will be determined via triplicate sensory evaluations (triangle tests).[At baseline and at 12 weeks after intervention commencement]