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
  Purpose

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.


Condition Intervention
Type 2 Diabetes Mellitus
Cardiovascular Disease
Obesity
Dietary Supplement: Reformulated products
Dietary Supplement: Conventional products

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Impact of Reformulated Product Consumption on Energy and Nutrient Intake, Body Composition, Vascular Function and Plasma Lipid and Glucose Concentrations

Resource links provided by NLM:


Further study details as provided by University of Reading:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 50
Study Start Date: March 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
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

  Eligibility

Ages Eligible for Study:   20 Years to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01645995

Locations
United Kingdom
Department of Food and Nutritional Sciences, University of Reading
Reading, Berks, United Kingdom, RG6 6AP
Sponsors and Collaborators
University of Reading
Investigators
Principal Investigator: Prof Julie A Lovegrove, BSc, PhD, RNutr University of Reading
  More Information

Publications:
Responsible Party: Julie Lovegrove, Professor of Metabolic Nutrition, University of Reading
ClinicalTrials.gov Identifier: NCT01645995     History of Changes
Other Study ID Numbers: 12/03
Study First Received: July 18, 2012
Last Updated: October 18, 2013
Health Authority: University Research Ethics Committee, University of Reading: UK

Additional relevant MeSH terms:
Cardiovascular Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 23, 2014