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

December 3, 2014 updated by: Julie Lovegrove, University of Reading

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Berks
      • Reading, Berks, United Kingdom, RG6 6AP
        • Department of Food and Nutritional Sciences, University of Reading

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 49 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • CON

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in body weight and body composition
Time Frame: 20 weeks. Baseline and week 8 assessments for two dietary intervention arms
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
Time Frame: 20 weeks. Run-in period and week 7 assessments for two dietary intervention arms
20 weeks. Run-in period and week 7 assessments for two dietary intervention arms
Changes in appetite and mood ratings
Time Frame: 20 weeks. Run-in period and week 7 assessments for two dietary intervention arms
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
Time Frame: 20 weeks. Run-in period and week 7 assessments for two dietary intervention arms
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
Time Frame: 20 weeks. Baseline and week 8 assessments for two dietary intervention arms
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)
Time Frame: 20 weeks. Baseline and week 8 assessments for two dietary intervention arms
20 weeks. Baseline and week 8 assessments for two dietary intervention arms
Changes in cardiovascular risk factors (blood pressure, inflammatory markers)
Time Frame: 20 weeks. Baseline and week 8 assessments for two dietary intervention arms
20 weeks. Baseline and week 8 assessments for two dietary intervention arms

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Reading

Investigators

  • Principal Investigator: Prof Julie A Lovegrove, BSc, PhD, RNutr, University of Reading

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

July 18, 2012

First Submitted That Met QC Criteria

July 18, 2012

First Posted (Estimate)

July 20, 2012

Study Record Updates

Last Update Posted (Estimate)

December 4, 2014

Last Update Submitted That Met QC Criteria

December 3, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12/03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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