Blood PressureNCT01640015
The Effect of Eating Frequency on Blood Pressure
A study testing dietary intervention in people with Blood Pressure, run by Imperial College London at 1 site in United Kingdom.
Trial summary
The primary purpose of this study is to identify the effect of meal frequency on blood pressure (BP) levels of individuals. Read more about this study
- Who is it for?
- Ages 35 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- What is being tested?
- dietary intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2012to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Weight change of ≥ 3kg in the preceding 2 months
- Current smokers
- Substance abuse
- Alcohol intake
- Pregnancy
- Diabetes
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sir John Michael Center - Hammersmith Hospital
London, w2
About this study
Official title: The Effect of Number of Eating Episodes Per Day on Blood Pressure. A Randomised Controlled Trial
The primary purpose of this study is to identify the effect of meal frequency on blood pressure (BP) levels of individuals.
Read the 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.
- Conditions
- Blood Pressure
- Being tested
- dietary intervention
- Keywords
- Blood pressure, eating episode, eating frequency, insulin sensitivity
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary interventionOther
a low frequency diet (3 meals/day) a high frequency diet (9 meals/day)
| Study group | Role | What they receive |
|---|---|---|
| low frequency diet | Experimental | Participants will be assigned to a low frequency diet (fixed energy intake) Receives: Other: dietary intervention |
| High frequency diet | Experimental | Not described Receives: Other: dietary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks for 24 hours through blood pressure monitor
Secondary outcomes (1)
Insulin
biomarkers like: Insulin - Glucose- lipid profile- Free fatty acids- C peptides- HS CRP will be measured regularly during study
Measured: measured twice during each phase (2 phases)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2012 (estimated)
- Study startJan 2012 (estimated)
- Primary completionJan 2012 (estimated)
- Study completionMar 2012 (estimated)
Why it stopped: Study did not get ethical approval, therefore study was not initiated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01640015
- Sponsor's protocol ID
- CRO197
- Status last verified
- Apr 2019
- First submitted
- 11 Jul 2012
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Number of Eating Episodes Per Day on Blood Pressure. A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01640015
- Acronym / sponsor ID
- CRO197
- Conditions
- Blood Pressure
- Keywords
- Blood pressure, eating episode, eating frequency, insulin sensitivity
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study did not get ethical approval, therefore study was not initiated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Jan 2012 (estimated)
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Mar 2012 (estimated)
- First posted
- 13 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to identify the effect of meal frequency on blood pressure (BP) levels of individuals.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low frequency diet | Experimental | Other: dietary interventionParticipants will be assigned to a low frequency diet (fixed energy intake) |
| High frequency diet | Experimental | Other: dietary intervention |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (13 listed)
- Weight change of ≥ 3kg in the preceding 2 months
- Current smokers
- Substance abuse
- Alcohol intake
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dietary interventiona low frequency diet (3 meals/day) a high frequency diet (9 meals/day) | Other | High frequency diet, low frequency diet |
Primary outcome
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.
1 secondary outcome
Insulin
Time frame: measured twice during each phase (2 phases)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
Related trials for Blood Pressure
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
RecruitingPhase 3
A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure
Chronic Kidney Disease and Hypertension
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingPhase 4
Hematological Safety of Dipyrone Versus Paracetamol After Dental Extractions
Hematologic Test, Agranulocytosis
Not yet recruiting
Acute Effects of Mat Pilates on Blood Pressure Response to Mental Stress in Higher Education Teachers
Behavior
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dietary intervention in people with Blood Pressure, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood pressure (time frame: 2 weeks for 24 hours through blood pressure monitor). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019.