Clinical trial NCT01645995: The Impact of Reformulated Foods on Cardiovascular Risk Factors
Official title: The Impact of Reformulated Product Consumption on Energy and Nutrient Intake, Body Composition, Vascular Function and Plasma Lipid and Glucose Concentrations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Cardiovascular Disease
Obesity
Lead sponsor: University of Reading
Sponsor class: OTHER
First posted: 2012-07-20
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Changes in body weight and body composition
timeFrame: 20 weeks. Baseline and week 8 assessments for two dietary intervention arms
Secondary outcomes:
measure: Changes in energy and nutrient intake
timeFrame: 20 weeks. Run-in period and week 7 assessments for two dietary intervention arms
measure: Changes in appetite and mood ratings
timeFrame: 20 weeks. Run-in period and week 7 assessments for two dietary intervention arms
measure: Changes in physical activity levels
timeFrame: 20 weeks. Run-in period and week 7 assessments for two dietary intervention arms
measure: Changes in fasting plasma lipid, insulin and glucose concentrations
timeFrame: 20 weeks. Baseline and week 8 assessments for two dietary intervention arms
measure: Changes in vascular stiffness by pulse wave analysis (PWA) and digital volume pulse (DVP)
timeFrame: 20 weeks. Baseline and week 8 assessments for two dietary intervention arms
measure: Changes in cardiovascular risk factors (blood pressure, inflammatory markers)
timeFrame: 20 weeks. Baseline and week 8 assessments for two dietary intervention arms
Other outcomes:
Locations:
city: Reading
country: United Kingdom
facility: Department of Food and Nutritional Sciences, University of Reading
state: Berks
Study officials:
affiliation: University of Reading
name: Prof Julie A Lovegrove, BSc, PhD, RNutr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reid M, Hammersley R, Duffy M. Effects of sucrose drinks on macronutrient intake, body weight, and mood state in overweight women over 4 weeks. Appetite. 2010 Aug;55(1):130-6. doi: 10.1016/j.appet.2010.05.001. Epub 2010 May 12.
citation: Reid M, Hammersley R, Hill AJ, Skidmore P. Long-term dietary compensation for added sugar: effects of supplementary sucrose drinks over a 4-week period. Br J Nutr. 2007 Jan;97(1):193-203. doi: 10.1017/S0007114507252705.