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

Primary Purpose

Type 2 Diabetes Mellitus, Cardiovascular Disease, Obesity

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Reformulated products
Conventional products
Sponsored by
University of Reading
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 2 Diabetes Mellitus

Eligibility Criteria

20 Years - 49 Years (Adult)All SexesAccepts 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

Sites / Locations

  • Department of Food and Nutritional Sciences, University of Reading

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Reformulated products

Conventional products

Arm 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.

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.

Outcomes

Primary Outcome Measures

Changes in body weight and body composition

Secondary Outcome Measures

Changes in energy and nutrient intake
Changes in appetite and mood ratings
Subjective sensations of appetite and mood by visual analogue scale
Changes in physical activity levels
Measured by accelerometry
Changes in fasting plasma lipid, insulin and glucose concentrations
Changes in vascular stiffness by pulse wave analysis (PWA) and digital volume pulse (DVP)
Changes in cardiovascular risk factors (blood pressure, inflammatory markers)

Full Information

First Posted
July 18, 2012
Last Updated
December 3, 2014
Sponsor
University of Reading
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1. Study Identification

Unique Protocol Identification Number
NCT01645995
Brief Title
The Impact of Reformulated Foods on Cardiovascular Risk Factors
Acronym
REFORM
Official Title
The Impact of Reformulated Product Consumption on Energy and Nutrient Intake, Body Composition, Vascular Function and Plasma Lipid and Glucose Concentrations
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Reading

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Cardiovascular Disease, Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reformulated products
Arm Type
Experimental
Arm 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.
Arm Title
Conventional products
Arm Type
Experimental
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Reformulated products
Other Intervention Name(s)
REF
Intervention 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Conventional products
Other Intervention Name(s)
CON
Intervention 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.
Primary Outcome Measure Information:
Title
Changes in body weight and body composition
Time Frame
20 weeks. Baseline and week 8 assessments for two dietary intervention arms
Secondary Outcome Measure Information:
Title
Changes in energy and nutrient intake
Time Frame
20 weeks. Run-in period and week 7 assessments for two dietary intervention arms
Title
Changes in appetite and mood ratings
Description
Subjective sensations of appetite and mood by visual analogue scale
Time Frame
20 weeks. Run-in period and week 7 assessments for two dietary intervention arms
Title
Changes in physical activity levels
Description
Measured by accelerometry
Time Frame
20 weeks. Run-in period and week 7 assessments for two dietary intervention arms
Title
Changes in fasting plasma lipid, insulin and glucose concentrations
Time Frame
20 weeks. Baseline and week 8 assessments for two dietary intervention arms
Title
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
Title
Changes in cardiovascular risk factors (blood pressure, inflammatory markers)
Time Frame
20 weeks. Baseline and week 8 assessments for two dietary intervention arms

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof Julie A Lovegrove, BSc, PhD, RNutr
Organizational Affiliation
University of Reading
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Food and Nutritional Sciences, University of Reading
City
Reading
State/Province
Berks
ZIP/Postal Code
RG6 6AP
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
20470840
Citation
Reid M, Hammersley R, Duffy M. Effects of sucrose drinks on macronutrient intake, body weight, and mood state in overweight women over 4 weeks. Appetite. 2010 Aug;55(1):130-6. doi: 10.1016/j.appet.2010.05.001. Epub 2010 May 12.
Results Reference
result
PubMed Identifier
17217576
Citation
Reid M, Hammersley R, Hill AJ, Skidmore P. Long-term dietary compensation for added sugar: effects of supplementary sucrose drinks over a 4-week period. Br J Nutr. 2007 Jan;97(1):193-203. doi: 10.1017/S0007114507252705.
Results Reference
result

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The Impact of Reformulated Foods on Cardiovascular Risk Factors

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