The Impact of Reformulated Foods on Cardiovascular Risk Factors

Obesity Clinical Trial

— REFORM  

Official title:

The Impact of Reformulated Product Consumption on Energy and Nutrient Intake, Body Composition, Vascular Function and Plasma Lipid and Glucose Concentrations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01645995
• Other study ID #: 12/03
• Status: Completed
• Phase: N/A
• First received: July 18, 2012
• Last updated: December 3, 2014
• Start date: March 2012
• Est. completion date: March 2013

Study information

• Verified date: December 2014
• Source: University of Reading
• Contact: n/a
• Is FDA regulated: No
• Health authority: University Research Ethics Committee, University of Reading: UK
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 49 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Diabetes Mellitus, Type 2
• Obesity
• Type 2 Diabetes Mellitus

Intervention

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.
• 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.

Locations

Country	Name	City	State
United Kingdom	Department of Food and Nutritional Sciences, University of Reading	Reading	Berks

Sponsors (1)

Lead Sponsor	Collaborator
University of Reading

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in body weight and body composition		20 weeks. Baseline and week 8 assessments for two dietary intervention arms	No
Secondary	Changes in energy and nutrient intake		20 weeks. Run-in period and week 7 assessments for two dietary intervention arms	No
Secondary	Changes in appetite and mood ratings	Subjective sensations of appetite and mood by visual analogue scale	20 weeks. Run-in period and week 7 assessments for two dietary intervention arms	No
Secondary	Changes in physical activity levels	Measured by accelerometry	20 weeks. Run-in period and week 7 assessments for two dietary intervention arms	No
Secondary	Changes in fasting plasma lipid, insulin and glucose concentrations		20 weeks. Baseline and week 8 assessments for two dietary intervention arms	No
Secondary	Changes in vascular stiffness by pulse wave analysis (PWA) and digital volume pulse (DVP)		20 weeks. Baseline and week 8 assessments for two dietary intervention arms	No
Secondary	Changes in cardiovascular risk factors (blood pressure, inflammatory markers)		20 weeks. Baseline and week 8 assessments for two dietary intervention arms	No