Study of the Effects of an Oral Nitric Oxide Supplement on Blood Pressure in Prehypertensive Adults
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|ClinicalTrials.gov Identifier: NCT01937754|
Recruitment Status : Unknown
Verified September 2013 by Dr. Ernst Schwarz, Neogenis Laboratories.
Recruitment status was: Active, not recruiting
First Posted : September 10, 2013
Last Update Posted : September 10, 2013
|Condition or disease||Intervention/treatment||Phase|
|Prehypertension||Dietary Supplement: Nitric Oxide supplement Dietary Supplement: Placebo||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Supportive Care|
|Official Title:||Study of the Effects of an Oral Nitric Oxide Supplement on Functional Capacity and Blood Pressure in Healthy Adults With Prehypertension|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||September 2013|
|Active Comparator: Nitric Oxide supplement||
Dietary Supplement: Nitric Oxide supplement
Lozenge consisting of beetroot and 75 mg caffeine
Other Name: Neo40 Daily
|Placebo Comparator: Placebo||
Dietary Supplement: Placebo
Same form factor and flavor as test lozenge but contains no active ingredients
- Reduction in Systolic and Diastolic Blood Pressure Readings [ Time Frame: 30 days ]Two blood pressure readings at rest will be taken at baseline and again after thirty days during the follow-up appointment.
- Improvement in Functional Capacity [ Time Frame: 30 days ]Participant will take a six minute walk test at baseline and again after thirty days during the follow-up appointment. Achieved distances will be measured and recorded.
- Improvement in Quality of Life [ Time Frame: 30 days ]Participants will fill out a standardized quality of life questionnaire at baseline and again after thirty days during the follow-up appointment. Summary component scores will be recorded and compared.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01937754
|United States, California|
|California Medical Institute|
|Beverly Hills, California, United States, 90211|
|Principal Investigator:||Ernst Schwarz, MD, PhD||California Medical Institute, Cedars Sinai Medical Center|