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The Effect of Eating Frequency on Blood Pressure

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ClinicalTrials.gov Identifier: NCT01640015
Recruitment Status : Unknown
Verified July 2012 by Imperial College London.
Recruitment status was:  Not yet recruiting
First Posted : July 13, 2012
Last Update Posted : July 13, 2012
Information provided by (Responsible Party):
Imperial College London

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

Condition or disease Intervention/treatment
Blood Pressure Other: dietary intervention

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Number of Eating Episodes Per Day on Blood Pressure. A Randomised Controlled Trial
Study Start Date : August 2012
Estimated Primary Completion Date : January 2013
Estimated Study Completion Date : March 2013

Arm Intervention/treatment
Experimental: low frequency diet
Participants will be assigned to a low frequency diet (fixed energy intake)
Other: dietary intervention
a low frequency diet (3 meals/day) a high frequency diet (9 meals/day)
Experimental: High frequency diet
Participants will be assigned to a high frequency diet (fixed energy intake)
Other: dietary intervention
a low frequency diet (3 meals/day) a high frequency diet (9 meals/day)

Primary Outcome Measures :
  1. blood pressure [ Time Frame: 2 weeks for 24 hours through blood pressure monitor ]
    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.

Secondary Outcome Measures :
  1. Insulin [ Time Frame: measured twice during each phase (2 phases) ]
    biomarkers like: Insulin - Glucose- lipid profile- Free fatty acids- C peptides- HS CRP will be measured regularly during study

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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01640015

Contact: Ghadeer Aljuraiban S Aljuraiban, Msc 07842780944 g.aljuraiban10@imperial.ac.uk

United Kingdom
Sir John Michael Center - Hammersmith Hospital Not yet recruiting
London, United Kingdom, w2
Sub-Investigator: Ghadeer Aljuraiban, Msc         
Sponsors and Collaborators
Imperial College London

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01640015     History of Changes
Other Study ID Numbers: CRO197
First Posted: July 13, 2012    Key Record Dates
Last Update Posted: July 13, 2012
Last Verified: July 2012

Keywords provided by Imperial College London:
Blood pressure
eating episode
eating frequency
insulin sensitivity