Type 2 Diabetes MellitusREFORMNCT01645995
The Impact of Reformulated Foods on Cardiovascular Risk Factors
A study testing Reformulated products and Conventional products in people with Type 2 Diabetes Mellitus and Cardiovascular Disease, run by University of Reading at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 20 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus, Cardiovascular Disease, Obesity
- What is being tested?
- Reformulated products and Conventional products
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2012to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Food and Nutritional Sciences, University of Reading
Reading, Berks, RG6 6AP
About this study
Official title: 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.
- Conditions
- Type 2 Diabetes Mellitus, Cardiovascular Disease, Obesity
- Being tested
- Reformulated products, Conventional products
- Medical subject headings
- Diabetes Mellitus, Type 2, Cardiovascular Diseases, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reformulated productsDietary supplement
Also called REF
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 productsDietary supplement
Also called CON
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.
| Study group | Role | What they receive |
|---|---|---|
| Reformulated products | Experimental | 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. Receives: Dietary Supplement: Reformulated products |
| Conventional products | Experimental | 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. Receives: Dietary Supplement: Conventional products |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in body weight and body composition
Measured: 20 weeks. Baseline and week 8 assessments for two dietary intervention arms
Secondary outcomes (6)
Changes in energy and nutrient intake
Measured: 20 weeks. Run-in period and week 7 assessments for two dietary intervention arms
Changes in appetite and mood ratings
Subjective sensations of appetite and mood by visual analogue scale
Measured: 20 weeks. Run-in period and week 7 assessments for two dietary intervention arms
Changes in physical activity levels
Measured by accelerometry
Measured: 20 weeks. Run-in period and week 7 assessments for two dietary intervention arms
Changes in fasting plasma lipid, insulin and glucose concentrations
Measured: 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)
Measured: 20 weeks. Baseline and week 8 assessments for two dietary intervention arms
Changes in cardiovascular risk factors (blood pressure, inflammatory markers)
Measured: 20 weeks. Baseline and week 8 assessments for two dietary intervention arms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2012 (estimated)
- Study startMar 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie Lovegrove, University of Reading
- Investigators
- Prof Julie A Lovegrove, BSc, PhD, RNutr, Principal investigator, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01645995
- Sponsor's protocol ID
- 12/03
- Acronym
- REFORM
- Status last verified
- Dec 2014
- First submitted
- 18 Jul 2012
- Last updated
- 4 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20470840Reid 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.
PubMed 17217576
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Reformulated Product Consumption on Energy and Nutrient Intake, Body Composition, Vascular Function and Plasma Lipid and Glucose Concentrations
- ClinicalTrials.gov ID
- NCT01645995
- Acronym / sponsor ID
- REFORM / 12/03
- Conditions
- Type 2 Diabetes Mellitus, Cardiovascular Disease, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 20 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reformulated products | Experimental | Dietary Supplement: Reformulated productsSubjects 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 | Experimental | Dietary Supplement: Conventional productsSubjects 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. |
Who may qualify
- Ages
- 20 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reformulated productsAlso: REFSubjects 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 |
| Conventional productsAlso: CONSubjects 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 |
Primary outcome
Changes in body weight and body composition
Time frame: 20 weeks. Baseline and week 8 assessments for two dietary intervention arms
6 secondary outcomes
Changes in energy and nutrient intake
Time frame: 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
Changes in physical activity levels
Time frame: 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
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
Changes in cardiovascular risk factors (blood pressure, inflammatory markers)
Time frame: 20 weeks. Baseline and week 8 assessments for two dietary intervention arms
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2014.
- Results publication: PubMed 20470840Reid 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 publication: PubMed 17217576Reid 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof Julie A Lovegrove, BSc, PhD, RNutr principal investigator
University of Reading
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reformulated products and Conventional products in people with Type 2 Diabetes Mellitus and Cardiovascular Disease, run by University of Reading at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in body weight and body composition (time frame: 20 weeks. Baseline and week 8 assessments for two dietary intervention arms). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01645995, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2014.