The Effects of Omega-3 Fatty Acids on Peripheral Arterial Disease II (OMEGA-PAD II)
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|ClinicalTrials.gov Identifier: NCT01979874|
Recruitment Status : Completed
First Posted : November 8, 2013
Last Update Posted : July 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Arterial Disease||Dietary Supplement: Pro-Omega Other: ProOmega Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||The Effects of Omega-3 Fatty Acids Supplementation on Endothelial Function and Inflammation II|
|Study Start Date :||February 2014|
|Actual Primary Completion Date :||September 2017|
|Actual Study Completion Date :||September 2017|
High-dose, short-duration dietary omega-3 fatty acids supplementation; 325mg of EPA and 225mg of DHA per capsule. 4.4gm/day x 3 months (Nordic Naturals, Watsonville, CA, USA)
Dietary Supplement: Pro-Omega
Pro-Omega (Nordic Naturals, Watsonville, CA, USA). Each ProOmega capsule contains 325mg of EPA and 225mg of DHA. 4.4gm/day x 3 months
Placebo Comparator: Placebo
Pro-Omega Placebo soybean capsules (Nordic Naturals, Watsonville, CA, USA); 4.4gm/day x 3 months
Other: ProOmega Placebo
Placebo Comparator: soybean (Nordic Naturals, Watsonville, CA, USA); 4.4gm/day x 3 months
- Systemic Inflammatory bio-markers [ Time Frame: 3 months ]reduce circulating pro-inflammatory markers (PIMs) and increase pro-resolution mediators (PRMs) assayed using targeted metabolo-lipidomics, increase PRM production within peripheral circulating monocytes.
- Endothelial Function [ Time Frame: 3 months ]Will increase brachial artery flow-mediated vasodilation (FMD)and peripheral resistance (AiX) and decrease arterial stiffness in the lower extremities (PWV).
- Walking Performance [ Time Frame: 3 months ]Will improve walking distance during 6-minute walk test and improve parameters on the walking impairment questionnaire (WIQ).
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): NCT01979874
|United States, California|
|San Francisco Veterans Affairs Medical Center|
|San Francisco, California, United States, 94121|
|Principal Investigator:||Warren Gasper, MD||UCSF & SFVAMC|