The Effect of Eating Frequency on Blood Pressure

Blood Pressure Clinical Trial

Official title:

The Effect of Number of Eating Episodes Per Day on Blood Pressure. A Randomised Controlled Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01640015
• Other study ID #: CRO197
• Status: Withdrawn
• Phase: N/A
• Start date: January 2012
• Est. completion date: March 2012

Study information

• Verified date: April 2019
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Blood Pressure

Intervention

Other:
• dietary intervention
a low frequency diet (3 meals/day) a high frequency diet (9 meals/day)

Locations

Country	Name	City	State
United Kingdom	Sir John Michael Center - Hammersmith Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood pressure	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.	2 weeks for 24 hours through blood pressure monitor
Secondary	Insulin	biomarkers like: Insulin - Glucose- lipid profile- Free fatty acids- C peptides- HS CRP will be measured regularly during study	measured twice during each phase (2 phases)