The Impact of Reformulated Foods on Cardiovascular Risk Factors

Study Overview
=================
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.

Official Title
-----------------
The Impact of Reformulated Product Consumption on Energy and Nutrient Intake, Body Composition, Vascular Function and Plasma Lipid and Glucose Concentrations

Conditions
-----------------
Type 2 Diabetes Mellitus, Cardiovascular Disease, Obesity

Intervention / Treatment
-----------------
* Dietary Supplement: Reformulated products
* Dietary Supplement: Conventional products


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 49 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reformulated products<br>Subjects were asked to supplement their habitual diet with reformulated sugar-reduced products for 8 weeks. Subjects were provided with reformulated beverages, sauces, condiments and snacks. They were asked to consume a minimum of 1 drink + 1 food portion intervention supplement daily, in exchange for habitually eaten equivalent foods. | Dietary Supplement: Reformulated products<br>* Subjects were asked to supplement their habitual diet with reformulated sugar-reduced products for 8 weeks. Subjects were provided with reformulated beverages, sauces, condiments and snacks. They were asked to consume a minimum of 1 drink + 1 food portion intervention supplement daily, in exchange for habitually eaten equivalent foods.<br>* Other names: REF;|
| Experimental: Conventional products<br>Subjects were asked to supplement their habitual diet with conventional sugar products for 8 weeks. Subjects were provided with conventional beverages, sauces, condiments and snacks. They were asked to consume a minimum of 1 drink + 1 food portion intervention supplement daily, in exchange for habitually eaten equivalent foods. | Dietary Supplement: Conventional products<br>* Subjects were asked to supplement their habitual diet with conventional sugar products for 8 weeks. Subjects were provided with conventional beverages, sauces, condiments and snacks. They were asked to consume a minimum of 1 drink + 1 food portion intervention supplement daily, in exchange for habitually eaten equivalent foods.<br>* Other names: CON;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in body weight and body composition |  | 20 weeks. Baseline and week 8 assessments for two dietary intervention arms | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in energy and nutrient intake |  | 20 weeks. Run-in period and week 7 assessments for two dietary intervention arms | 
| Changes in appetite and mood ratings | Subjective sensations of appetite and mood by visual analogue scale | 20 weeks. Run-in period and week 7 assessments for two dietary intervention arms | 
| Changes in physical activity levels | Measured by accelerometry | 20 weeks. Run-in period and week 7 assessments for two dietary intervention arms | 
| Changes in fasting plasma lipid, insulin and glucose concentrations |  | 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 | 
| Changes in cardiovascular risk factors (blood pressure, inflammatory markers) |  | 20 weeks. Baseline and week 8 assessments for two dietary intervention arms |