- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01640015
The Effect of Eating Frequency on Blood Pressure
The Effect of Number of Eating Episodes Per Day on Blood Pressure. A Randomised Controlled Trial
Studieoversigt
Detaljeret beskrivelse
Migration studies, observational epidemiology and clinical trial data indicate that causes of adverse BP levels are mainly environmental , including lifestyle under which dietary factors play a role. Therefore, lifestyle modification is part of the current American Heart Association recommendations for prevention and control of adverse BP levels.
Although the effects of nutrients and foods on BP have been studied extensively, other dietetic factors such as eating frequency and number of meals in a day have been less thoroughly investigated and warrant further research to explore their possible positive effect on BP.
Undersøgelsestype
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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London, Det Forenede Kongerige, w2
- Sir John Michael Center - Hammersmith Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
Healthy individuals aged 35-70 years with prehypertension (systolic/diastolic BP 120-139/80-89 mm Hg) BMI 20-30 kg/m2 non-smoking non alcoholic drinkers
Exclusion Criteria:
- Weight change of ≥ 3kg in the preceding 2 months
- Current smokers
- Substance abuse
- Alcohol intake
- Pregnancy
- Diabetes
- Cardiovascular disease
- Cancer
- Gastrointestinal disease e.g. inflammatory bowel disease or irritable bowel syndrome
- Kidney disease
- Liver disease
- Pancreatitis
- Use of medications including: anti inflammatory drugs or steroids, antihypertensive drugs, cholesterol lowering medication, androgens, phenytoin, erythromycin or thyroid hormones.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: low frequency diet
Participants will be assigned to a low frequency diet (fixed energy intake)
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a low frequency diet (3 meals/day) a high frequency diet (9 meals/day)
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Eksperimentel: High frequency diet
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a low frequency diet (3 meals/day) a high frequency diet (9 meals/day)
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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blood pressure
Tidsramme: 2 weeks for 24 hours through blood pressure monitor
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Participants will be asked to wear BP monitor continuously for one week then return it back either by post or bring it themselves to the center.
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2 weeks for 24 hours through blood pressure monitor
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Insulin
Tidsramme: measured twice during each phase (2 phases)
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biomarkers like: Insulin - Glucose- lipid profile- Free fatty acids- C peptides- HS CRP will be measured regularly during study
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measured twice during each phase (2 phases)
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Forventet)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- CRO197
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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