Blood PressurePhase 2NCT02353104
The Effects of the Onion-Pumpkin Extract on Blood Pressure
A Phase 2 study testing Onion-Pumpkin Extract in people with Blood Pressure, run by Medicus Research, LLC.
Trial summary
This open-label, adaptive-design, pilot study was designed to evaluate the effect of Onion-Pumpkin Extract in supporting healthy blood pressure as assessed by the change in systolic and diastolic blood pressures. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- What is being tested?
- Onion-Pumpkin Extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Nov 2013to Aug 2014
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI ≥ 25 and ≤ 35 kg/m2
- Blood pressure:
- SBP: 140-160 mmHg
- DBP: 80-90 mmHg
- Judged by the Investigator to be in general good health on the basis of medical history
- Females of child bearing potential must agree to use appropriate birth control methods during the entire study period.
- Understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator.
Who cannot join
- Subjects currently taking any antihypertensive medications
- Subjects taking prescription blood pressure, cholesterol and/or diabetes medication.
- Subjects currently taking dietary supplements or over the counter medication. (2 week washout allowed)
- History or presence of cancer in the prior two years.
- Recent history of (within 12 months) or strong potential for alcohol or substance abuse.
- Current tobacco smokers
Show all 13Show fewer
- Participation in a clinical study with exposure to any non-registered drug product within 30 days prior.
- Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk
- Including subjects who are Bed or wheelchair-bound
- Clinically significant abnormal Physical Examination.
- Central Neurological disorders including but not limited to Spinal cord injuries, multiple sclerosis, and Parkinson disease.
- Pregnant, lactating, or unwilling to use adequate contraception during the duration of the study.
- Any other condition that, in the opinion of the investigator, would adversely affect the subject's ability to complete the study or its measures.
About this study
Official title: The Effects of the Onion-Pumpkin Extract on Blood Pressure: An Open-label, Adaptive-design, Pilot Study
This open-label, adaptive-design, pilot study was designed to evaluate the effect of Onion-Pumpkin Extract in supporting healthy blood pressure as assessed by the change in systolic and diastolic blood pressures. The effect of the product on glucose metabolism, lipid levels, and antioxidant levels would also be determined. Tolerability and safety of the study product would also be investigated.
Read the detailed description
Hypertension has become one of the most common diseases in the world and considered a public health challenge due to its association with morbidity and mortality and increased cost to society. Hypertension is the most important risk factor for cardiovascular diseases such as coronary heart disease, stroke, congestive heart failure, and peripheral vascular disease. One fourth of adults in the United States have high blood pressure and among these, the blacks and the elderly have higher incidence of hypertension. This condition is characterized by abnormally high blood pressure with the systolic greater than 140 mmHg and diastolic greater than 90 mmHg (1).
Lowering blood pressure has been linked to 35% to 40% reductions in the incidence of stroke, 20%-25% in myocardial infarction, and 50% in heart failure. Management of hypertension includes lifestyle modifications and pharmacological therapy and antihypertensive drugs. Lifestyle modifications such as weight reduction in overweight and obese individuals, 8-week diet of fruits, vegetables, low-fat dairy products, whole grain, poultry fish and nuts with limited fats, red meat and sweets, reduction in dietary sodium, physical activity, and moderation of alcohol consumption have been shown to lower blood pressure. There are several classes of antihypertensive drugs, including angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs) β-blockers (BBs), calcium channel blockers (CCBs) and the thiazide-class diuretics. Among these, the diuretic based therapy was more effective than other treatments in preventing cardiovascular diseases as demonstrated by the Antihypertensive and Lipid-lowering Treatment to prevent Heart Attack (ALLHAT) trial (1, 2).
Blood pressure can be lowered without using prescription drugs. Nutraceuticals have found their application in the treatment of hypertension. Omega-3 polyunsaturated fatty acids, omega-9 fatty acids, garlic, seaweed, and various vitamins and minerals have been shown to reduce blood pressure significantly (3).
Animal studies have demonstrated the potential benefits of onion in hypertensive rats. In one study involving rats fed with a control diet or a high-fat high-sucrose diet with or without Welsh onion for 4 weeks, lower blood pressure was observed in rats with onion diet, especially the green-leafy type. In addition, these rats have higher levels of nitric oxide (NO) metabolites in the urine and plasma, lower activity of NADH/NADPH oxidase in the aorta, and suppressed angiotensin II production (4). The mechanism of the antihypertensive effect of onion probably involves increased saving of NO (4, 5). A randomized, placebo-controlled, double-blind trial also demonstrated significant decrease in arterial blood pressure and reduction in plasma viscosity five hours after administration of a formulation containing onion and olive oil (6).
Pumpkin has been used as a traditional medicine and it is known for its antidiabetic, antitumor, antibacterial, anti-inflammatory, and antihypertensive properties (7). Animal studies confirmed that pumpkin seed oil supplementation resulted in lower systolic and diastolic blood pressure as well as improvements in lipid profile in both non-ovariectomized and ovariectomized rats (8). Using enzyme assays, it was demonstrated that pumpkin have moderate to high alpha-glucosidase and ACE inhibitory activities (9). A recent clinical trial involved postmenopausal women and the effects of supplemented pumpkin seed oil in cholesterol levels. The results of this trial showed that 12-week administration of 2g/day pumpkin seed oil led to a significant increase in HDL cholesterol and significant decrease in diastolic blood pressure. Pumpkin seed oil also improved menopausal symptom scores by decreasing hot flushes, headaches, and joint pains (10).
This open-label, adaptive-design, pilot study was designed to evaluate the effect of Onion-Pumpkin Extract in supporting healthy blood pressure as assessed by the change in systolic and diastolic blood pressures. The effect of the product on glucose metabolism, lipid levels, and antioxidant levels would also be determined. Tolerability and safety of the study product would also be investigated.
- Conditions
- Blood Pressure
- Being tested
- Onion-Pumpkin Extract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Onion-Pumpkin ExtractDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Onion-Pumpkin Extract | Experimental | Take two capsules, twice daily before breakfast and dinner Receives: Dietary Supplement: Onion-Pumpkin Extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic Blood Pressure
Change in Individual SBP Values
Measured: 12 weeks
Systolic Blood Pressure (Change in Mean SBP Values)
Change in Mean SBP Values
Measured: 12 weeks
Diastolic Blood Pressure (Change in Individual DBP Values)
Change in Individual DBP Values
Measured: 12 weeks
Diastolic Blood Pressure (Change in Mean DBP Values)
Change in Mean DBP Values
Measured: 12 weeks
Secondary outcomes (2)
Change in complete blood cell count (CBC)
Measured: 12 weeks
Change in Comprehensive Metabolic Panel (CMP)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2015 (estimated)
- Study startNov 2013
- Primary completionAug 2014
- Study completionAug 2014
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.
- 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 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medicus Research, LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02353104
- Sponsor's protocol ID
- HORN1000
- Status last verified
- Jan 2015
- First submitted
- 20 Jan 2015
- Last updated
- 2 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of the Onion-Pumpkin Extract on Blood Pressure: An Open-label, Adaptive-design, Pilot Study
- ClinicalTrials.gov ID
- NCT02353104
- Acronym / sponsor ID
- HORN1000
- Conditions
- Blood Pressure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Medicus Research, LLCUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 2 Feb 2015 (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.
This open-label, adaptive-design, pilot study was designed to evaluate the effect of Onion-Pumpkin Extract in supporting healthy blood pressure as assessed by the change in systolic and diastolic blood pressures. The effect of the product on glucose metabolism, lipid levels, and antioxidant levels would also be determined. Tolerability and safety of the study product would also be investigated.
Detailed description
Hypertension has become one of the most common diseases in the world and considered a public health challenge due to its association with morbidity and mortality and increased cost to society. Hypertension is the most important risk factor for cardiovascular diseases such as coronary heart disease, stroke, congestive heart failure, and peripheral vascular disease. One fourth of adults in the United States have high blood pressure and among these, the blacks and the elderly have higher incidence of hypertension. This condition is characterized by abnormally high blood pressure with the systolic greater than 140 mmHg and diastolic greater than 90 mmHg (1).
Lowering blood pressure has been linked to 35% to 40% reductions in the incidence of stroke, 20%-25% in myocardial infarction, and 50% in heart failure. Management of hypertension includes lifestyle modifications and pharmacological therapy and antihypertensive drugs. Lifestyle modifications such as weight reduction in overweight and obese individuals, 8-week diet of fruits, vegetables, low-fat dairy products, whole grain, poultry fish and nuts with limited fats, red meat and sweets, reduction in dietary sodium, physical activity, and moderation of alcohol consumption have been shown to lower blood pressure. There are several classes of antihypertensive drugs, including angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs) β-blockers (BBs), calcium channel blockers (CCBs) and the thiazide-class diuretics. Among these, the diuretic based therapy was more effective than other treatments in preventing cardiovascular diseases as demonstrated by the Antihypertensive and Lipid-lowering Treatment to prevent Heart Attack (ALLHAT) trial (1, 2).
Blood pressure can be lowered without using prescription drugs. Nutraceuticals have found their application in the treatment of hypertension. Omega-3 polyunsaturated fatty acids, omega-9 fatty acids, garlic, seaweed, and various vitamins and minerals have been shown to reduce blood pressure significantly (3).
Animal studies have demonstrated the potential benefits of onion in hypertensive rats. In one study involving rats fed with a control diet or a high-fat high-sucrose diet with or without Welsh onion for 4 weeks, lower blood pressure was observed in rats with onion diet, especially the green-leafy type. In addition, these rats have higher levels of nitric oxide (NO) metabolites in the urine and plasma, lower activity of NADH/NADPH oxidase in the aorta, and suppressed angiotensin II production (4). The mechanism of the antihypertensive effect of onion probably involves increased saving of NO (4, 5). A randomized, placebo-controlled, double-blind trial also demonstrated significant decrease in arterial blood pressure and reduction in plasma viscosity five hours after administration of a formulation containing onion and olive oil (6).
Pumpkin has been used as a traditional medicine and it is known for its antidiabetic, antitumor, antibacterial, anti-inflammatory, and antihypertensive properties (7). Animal studies confirmed that pumpkin seed oil supplementation resulted in lower systolic and diastolic blood pressure as well as improvements in lipid profile in both non-ovariectomized and ovariectomized rats (8). Using enzyme assays, it was demonstrated that pumpkin have moderate to high alpha-glucosidase and ACE inhibitory activities (9). A recent clinical trial involved postmenopausal women and the effects of supplemented pumpkin seed oil in cholesterol levels. The results of this trial showed that 12-week administration of 2g/day pumpkin seed oil led to a significant increase in HDL cholesterol and significant decrease in diastolic blood pressure. Pumpkin seed oil also improved menopausal symptom scores by decreasing hot flushes, headaches, and joint pains (10).
This open-label, adaptive-design, pilot study was designed to evaluate the effect of Onion-Pumpkin Extract in supporting healthy blood pressure as assessed by the change in systolic and diastolic blood pressures. The effect of the product on glucose metabolism, lipid levels, and antioxidant levels would also be determined. Tolerability and safety of the study product would also be investigated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Onion-Pumpkin Extract | Experimental | Dietary Supplement: Onion-Pumpkin ExtractTake two capsules, twice daily before breakfast and dinner |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- BMI ≥ 25 and ≤ 35 kg/m2
- Blood pressure:
- Judged by the Investigator to be in general good health on the basis of medical history
- Females of child bearing potential must agree to use appropriate birth control methods during the entire study period.
- Understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator.
Key exclusion criteria (13 listed)
- Subjects currently taking any antihypertensive medications
- Subjects taking prescription blood pressure, cholesterol and/or diabetes medication.
- Subjects currently taking dietary supplements or over the counter medication. (2 week washout allowed)
- History or presence of cancer in the prior two years.
- Recent history of (within 12 months) or strong potential for alcohol or substance abuse.
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 |
|---|---|---|
| Onion-Pumpkin Extract | Dietary supplement | Onion-Pumpkin Extract |
Primary outcome
Systolic Blood Pressure
Time frame: 12 weeks
Change in Individual SBP Values
Systolic Blood Pressure (Change in Mean SBP Values)
Time frame: 12 weeks
Change in Mean SBP Values
Diastolic Blood Pressure (Change in Individual DBP Values)
Time frame: 12 weeks
Change in Individual DBP Values
Diastolic Blood Pressure (Change in Mean DBP Values)
Time frame: 12 weeks
Change in Mean DBP Values
2 secondary outcomes
Change in complete blood cell count (CBC)
Time frame: 12 weeks
Change in Comprehensive Metabolic Panel (CMP)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2015.
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Onion-Pumpkin Extract in people with Blood Pressure, run by Medicus Research, LLC.
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 7 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: finished, as of the sponsor's last update on 2 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Systolic Blood Pressure (time frame: 12 weeks). The study lists 4 primary outcomes in all. 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 2 Feb 2015.