The Impact of Reformulated Foods on Cardiovascular Risk Factors (REFORM)

University of Reading

Status: Completed

Conditions: Type 2 Diabetes Mellitus; Obesity; Cardiovascular Disease

Treatments: Dietary Supplement: Reformulated products; Dietary Supplement: Conventional products

Study type: Interventional

Funder types: Other

Identifiers

NCT01645995

12/03

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 20 to 49 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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50 participants in 2 patient groups

Reformulated products

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Reformulated products

Conventional products

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Conventional products