The Impact of Reformulated Foods on Cardiovascular Risk Factors (REFORM)
3 december 2014 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
50
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Berks
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Reading, Berks, Storbritannien, RG6 6AP
- Department of Food and Nutritional Sciences, University of Reading
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
20 år till 49 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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.
|
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.
Andra namn:
|
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Experimentell: 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.
|
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.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Changes in body weight and body composition
Tidsram: 20 weeks. Baseline and week 8 assessments for two dietary intervention arms
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20 weeks. Baseline and week 8 assessments for two dietary intervention arms
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Changes in energy and nutrient intake
Tidsram: 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
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|
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Changes in appetite and mood ratings
Tidsram: 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
Tidsram: 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
|
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Changes in fasting plasma lipid, insulin and glucose concentrations
Tidsram: 20 weeks. Baseline and week 8 assessments for two dietary intervention arms
|
20 weeks. Baseline and week 8 assessments for two dietary intervention arms
|
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Changes in vascular stiffness by pulse wave analysis (PWA) and digital volume pulse (DVP)
Tidsram: 20 weeks. Baseline and week 8 assessments for two dietary intervention arms
|
20 weeks. Baseline and week 8 assessments for two dietary intervention arms
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|
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Changes in cardiovascular risk factors (blood pressure, inflammatory markers)
Tidsram: 20 weeks. Baseline and week 8 assessments for two dietary intervention arms
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20 weeks. Baseline and week 8 assessments for two dietary intervention arms
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Prof Julie A Lovegrove, BSc, PhD, RNutr, University of Reading
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 mars 2012
Primärt slutförande (Faktisk)
1 mars 2013
Avslutad studie (Faktisk)
1 mars 2013
Studieregistreringsdatum
Först inskickad
18 juli 2012
Först inskickad som uppfyllde QC-kriterierna
18 juli 2012
Första postat (Uppskatta)
20 juli 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
4 december 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
3 december 2014
Senast verifierad
1 december 2014
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 12/03
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .