The Impact of Reformulated Foods on Cardiovascular Risk Factors

NCT ID: NCT01645995

Last Updated: 2014-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus Cardiovascular Disease Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Reformulated products

Intervention Type DIETARY_SUPPLEMENT

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.

Group Type EXPERIMENTAL

Conventional products

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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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 Type 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.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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REF CON

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Reading

OTHER

Sponsor Role lead

Responsible Party

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Julie Lovegrove

Professor of Metabolic Nutrition

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Prof Julie A Lovegrove, BSc, PhD, RNutr

Role: PRINCIPAL_INVESTIGATOR

University of Reading

Locations

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Department of Food and Nutritional Sciences, University of Reading

Reading, Berks, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type RESULT
PMID: 20470840 (View on PubMed)

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.

Reference Type RESULT
PMID: 17217576 (View on PubMed)

Other Identifiers

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12/03

Identifier Type: -

Identifier Source: org_study_id