The Effects of the Onion-Pumpkin Extract on Blood Pressure

NCT02353104 | Completed Phase 2

• 1 other identifier: HORN1000
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Outcome Measures

Primary Outcomes (4)

• Systolic Blood Pressure

  Change in Individual SBP Values

  12 weeks

• Systolic Blood Pressure (Change in Mean SBP Values)

  Change in Mean SBP Values

  12 weeks

• Diastolic Blood Pressure (Change in Individual DBP Values)

  Change in Individual DBP Values

  12 weeks

• Diastolic Blood Pressure (Change in Mean DBP Values)

  Change in Mean DBP Values

  12 weeks

Secondary Outcomes (2)

• Change in complete blood cell count (CBC)

  12 weeks

• Change in Comprehensive Metabolic Panel (CMP)

  12 weeks

Study Arms (1)

Onion-Pumpkin Extract

EXPERIMENTAL

Take two capsules, twice daily before breakfast and dinner

Dietary Supplement: Onion-Pumpkin Extract

Interventions

Onion-Pumpkin Extract DIETARY_SUPPLEMENT

Onion-Pumpkin Extract

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Medicus Research, LLC: lead

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2015
• First Posted: February 2, 2015
• Study Start: November 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: February 2, 2015

Record last verified: 2015-01