The Impact of Reformulated Foods on Cardiovascular Risk Factors
- Conditions
- ObesityType 2 Diabetes MellitusCardiovascular Disease
- Registration Number
- NCT01645995
- Lead Sponsor
- University of Reading
- Brief Summary
Specific policies on obesity reduction often include a recommendation to reduce sugar consumption as a means of lowering overall caloric intake. Reformulating processed foods (e.g. sugary products) is considered one of the key options for improving population diet. The implications of regular consumption of reformulated products are not fully understood. Previous studies have demonstrated that dietary compensation is common, although the extent is not fully elucidated. In addition to the perceived impact of sugar consumption on weight control, high sugar intake, specifically sucrose and fructose, has been implicated in the increase of plasma lipids and markers of insulin resistance. However to date no randomised controlled study has investigated whether the consumption of reformulated low sugar products as components of a habitual diet have a significant impact on plasma lipid, insulin or glucose concentrations within a free-living, non-diseased population. It is hypothesised that exchange of reformulated, low sugar food products for habitually consumed foods will result in dietary compensation and minimal weight change compared with unmodified products and will have little impact on plasma glucose, insulin and lipid levels.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- Age: 20 - 49 years
- BMI 18.5 - 30 kg/m2
- Plasma glucose <7 mmol/l (Not diagnosed with diabetes)
- Plasma cholesterol <7 mmol/l
- Plasma TAG <2.3 mmol/l
- Normal liver and kidney function
- Haemoglobin (>110 g/l women; 140g/dl men)
- Having suffered a myocardial infarction/stroke in the past 12 months
- diabetic (diagnosed or fasting glucose > 7 mmol/l)
- Smoking
- On drug treatment for hyperlipidaemia, hypertension, inflammation or hypercoagulation
- Suffering from renal or bowel disease or have a history of choleostatic liver or pancreatitis
- Excessive alcohol consumption
- History of alcohol abuse
- Following a reducing diet or vegan diet
- Taking any fish oil, fatty acid or vitamin and mineral supplements
- Participating in intensive aerobic activity for > 20 minutes 3 times per week
- Food allergies
- Anti-inflammatory usage
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Changes in body weight and body composition 20 weeks. Baseline and week 8 assessments for two dietary intervention arms
- Secondary Outcome Measures
Name Time Method Changes in energy and nutrient intake 20 weeks. Run-in period and week 7 assessments for two dietary intervention arms Changes in physical activity levels 20 weeks. Run-in period and week 7 assessments for two dietary intervention arms Measured by accelerometry
Changes in appetite and mood ratings 20 weeks. Run-in period and week 7 assessments for two dietary intervention arms Subjective sensations of appetite and mood by visual analogue scale
Changes in fasting plasma lipid, insulin and glucose concentrations 20 weeks. Baseline and week 8 assessments for two dietary intervention arms Changes in cardiovascular risk factors (blood pressure, inflammatory markers) 20 weeks. Baseline and week 8 assessments for two dietary intervention arms Changes in vascular stiffness by pulse wave analysis (PWA) and digital volume pulse (DVP) 20 weeks. Baseline and week 8 assessments for two dietary intervention arms
Trial Locations
- Locations (1)
Department of Food and Nutritional Sciences, University of Reading
🇬🇧Reading, Berks, United Kingdom
Department of Food and Nutritional Sciences, University of Reading🇬🇧Reading, Berks, United Kingdom