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The Impact of Reformulated Foods on Cardiovascular Risk Factors (REFORM)
3 december 2014 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
50
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Berks
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Reading, Berks, Verenigd Koninkrijk, RG6 6AP
- Department of Food and Nutritional Sciences, University of Reading
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
20 jaar tot 49 jaar (Volwassen)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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.
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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.
Andere namen:
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Experimenteel: 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.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Changes in body weight and body composition
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Changes in energy and nutrient intake
Tijdsspanne: 20 weeks. Run-in period and week 7 assessments for two dietary intervention arms
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20 weeks. Run-in period and week 7 assessments for two dietary intervention arms
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Changes in appetite and mood ratings
Tijdsspanne: 20 weeks. Run-in period and week 7 assessments for two dietary intervention arms
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Subjective sensations of appetite and mood by visual analogue scale
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20 weeks. Run-in period and week 7 assessments for two dietary intervention arms
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Changes in physical activity levels
Tijdsspanne: 20 weeks. Run-in period and week 7 assessments for two dietary intervention arms
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Measured by accelerometry
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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
Tijdsspanne: 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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Changes in vascular stiffness by pulse wave analysis (PWA) and digital volume pulse (DVP)
Tijdsspanne: 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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Changes in cardiovascular risk factors (blood pressure, inflammatory markers)
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Prof Julie A Lovegrove, BSc, PhD, RNutr, University of Reading
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 maart 2012
Primaire voltooiing (Werkelijk)
1 maart 2013
Studie voltooiing (Werkelijk)
1 maart 2013
Studieregistratiedata
Eerst ingediend
18 juli 2012
Eerst ingediend dat voldeed aan de QC-criteria
18 juli 2012
Eerst geplaatst (Schatting)
20 juli 2012
Updates van studierecords
Laatste update geplaatst (Schatting)
4 december 2014
Laatste update ingediend die voldeed aan QC-criteria
3 december 2014
Laatst geverifieerd
1 december 2014
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 12/03
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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