The Effect of Eating Frequency on Blood Pressure

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Imperial College London.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01640015
First received: July 11, 2012
Last updated: July 12, 2012
Last verified: July 2012
  Purpose

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


Condition Intervention
Blood Pressure
Other: dietary intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Number of Eating Episodes Per Day on Blood Pressure. A Randomised Controlled Trial

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • blood pressure [ Time Frame: 2 weeks for 24 hours through blood pressure monitor ] [ Designated as safety issue: No ]
    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:
  • Insulin [ Time Frame: measured twice during each phase (2 phases) ] [ Designated as safety issue: No ]
    biomarkers like: Insulin - Glucose- lipid profile- Free fatty acids- C peptides- HS CRP will be measured regularly during study


Estimated Enrollment: 30
Study Start Date: August 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01640015

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

Locations
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
  More Information

No publications provided

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01640015     History of Changes
Other Study ID Numbers: CRO197
Study First Received: July 11, 2012
Last Updated: July 12, 2012
Health Authority: United Kingdom: Research Ethics Committee

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

ClinicalTrials.gov processed this record on October 19, 2014