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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Julie Lovegrove, University of Reading
ClinicalTrials.gov Identifier:
NCT01645995
First received: July 18, 2012
Last updated: October 18, 2013
Last verified: October 2013

July 18, 2012
October 18, 2013
March 2012
March 2013   (final data collection date for primary outcome measure)
Changes in fasting plasma lipid, insulin and glucose concentrations [ Time Frame: 20 weeks. Baseline and week 8 assessments for two dietary intervention arms ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01645995 on ClinicalTrials.gov Archive Site
  • Changes in energy and nutrient intake [ Time Frame: 20 weeks. Run-in period and week 7 assessments for two dietary intervention arms ] [ Designated as safety issue: No ]
  • Changes in appetite and mood ratings [ Time Frame: 20 weeks. Run-in period and week 7 assessments for two dietary intervention arms ] [ Designated as safety issue: No ]
    Subjective sensations of appetite and mood by visual analogue scale
  • Changes in physical activity levels [ Time Frame: 20 weeks. Run-in period and week 7 assessments for two dietary intervention arms ] [ Designated as safety issue: No ]
    Measured by accelerometry
  • Changes in body weight and body composition [ Time Frame: 20 weeks. Baseline and week 8 assessments for two dietary intervention arms ] [ Designated as safety issue: No ]
  • Changes in vascular stiffness by pulse wave analysis (PWA) and digital volume pulse (DVP) [ Time Frame: 20 weeks. Baseline and week 8 assessments for two dietary intervention arms ] [ Designated as safety issue: No ]
  • Changes in cardiovascular risk factors (blood pressure, inflammatory markers) [ Time Frame: 20 weeks. Baseline and week 8 assessments for two dietary intervention arms ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Impact of Reformulated Foods on Cardiovascular Risk Factors
The Impact of Reformulated Product Consumption on Energy and Nutrient Intake, Body Composition, Vascular Function and Plasma Lipid and Glucose Concentrations

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Type 2 Diabetes Mellitus
  • Cardiovascular Disease
  • Obesity
  • Dietary Supplement: Reformulated 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.
    Other Name: REF
  • Dietary Supplement: Conventional 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.
    Other Name: CON
  • Experimental: Reformulated 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.
    Intervention: Dietary Supplement: Reformulated products
  • Experimental: Conventional 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.
    Intervention: Dietary Supplement: Conventional products

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
March 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
20 Years to 49 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01645995
12/03
Yes
Julie Lovegrove, University of Reading
University of Reading
Not Provided
Principal Investigator: Prof Julie A Lovegrove, BSc, PhD, RNutr University of Reading
University of Reading
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP