Cardiovascular Disease, Obesity, Type 2 Diabetes Mellitus
Conditions
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.
Interventions
DIETARY_SUPPLEMENTReformulated products
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_SUPPLEMENTConventional products
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.
Sponsors
University of Reading
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 49 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in body weight and body composition | 20 weeks. Baseline and week 8 assessments for two dietary intervention arms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 physical activity levels | 20 weeks. Run-in period and week 7 assessments for two dietary intervention arms | Measured by accelerometry |
| Changes in energy and nutrient intake | 20 weeks. Run-in period and week 7 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 | — |
| Changes in fasting plasma lipid, insulin and glucose concentrations | 20 weeks. Baseline and week 8 assessments for two dietary intervention arms | — |
Countries
United Kingdom
Outcome results
None listed