The Effect of Eating Frequency on Blood Pressure

NCT ID: NCT01640015

Last Updated: 2019-04-17

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-03-31

Brief Summary

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The primary purpose of this study is to identify the effect of meal frequency on blood pressure (BP) levels of individuals.

Detailed Description

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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.

Conditions

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Blood Pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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low frequency diet

Participants will be assigned to a low frequency diet (fixed energy intake)

Group Type EXPERIMENTAL

dietary intervention

Intervention Type OTHER

a low frequency diet (3 meals/day) a high frequency diet (9 meals/day)

High frequency diet

Group Type EXPERIMENTAL

dietary intervention

Intervention Type OTHER

a low frequency diet (3 meals/day) a high frequency diet (9 meals/day)

Interventions

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dietary intervention

a low frequency diet (3 meals/day) a high frequency diet (9 meals/day)

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sir John Michael Center - Hammersmith Hospital

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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CRO197

Identifier Type: -

Identifier Source: org_study_id

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