The Effect of Eating Frequency on Blood Pressure

Study Overview
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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.

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

Conditions
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Blood Pressure

Intervention / Treatment
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* Other: dietary intervention


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: low frequency diet<br>Participants will be assigned to a low frequency diet (fixed energy intake) | Other: dietary intervention<br>* a low frequency diet (3 meals/day) a high frequency diet (9 meals/day)<br>|
| Experimental: High frequency diet<br> | Other: dietary intervention<br>* a low frequency diet (3 meals/day) a high frequency diet (9 meals/day)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood pressure, eating episode, eating frequency, insulin sensitivity