Status:
WITHDRAWN
Effects of Bend Beauty's Anti-Aging Formula on Inflammatory Markers
Lead Sponsor:
Bend Beauty Inc.
Conditions:
Inflammation
Skin Abnormalities
Eligibility:
All Genders
35-65 years
Phase:
NA
Brief Summary
This is a phase IV, randomized, double-blind, placebo-controlled, three-arm, parallel intervention study including three groups of 25 subjects between 35-65 years of age, treated with either Bend Beau...
Detailed Description
This is a phase IV, randomized, double-blind, placebo-controlled, three-arm, parallel intervention study including three groups of 25 subjects between 35-65 years of age, treated with either Bend Beau...
Eligibility Criteria
Inclusion
- Provision of a signed and dated informed consent form (ICF)
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 35-65 years
- Subjects with Omega-3 Index of 5 or less.
- Subjects with Chronic Inflammation Scores of 415 or greater.
Exclusion
- Subjects who are unwilling to provide blood and urine samples during the initial and subsequent test points.
- Subjects that have consumed Anti-Aging Formula, omega-3 fatty acid (i.e. fish oil, krill oil, algal oil), lutein, zeaxanthin, carotenoids, GLA (borage or evening primrose oils) and/or Vitamin D supplements during the last 3 months
- Subjects who were ill (i.e. rhino virus, influenza, etc.) within two weeks prior to the study start, or who have any active systemic infection (infected tooth, bladder infection, sinus infection, etc.)
- Subjects taking:
- Anti-inflammatory medications including the nonsteroidal anti-inflammatory drugs (NSAID), cyclooxygenase (COX)-1 and COX-2 inhibitors, such as aspirin, ibuprofen (Advil and Voltaren), and naproxen, and acetaminophen (Tylenol®), either routinely or during the 7 days before baseline urine and blood testing.
- H2 antagonist/blockers \[e.g. cimetidine (Tagamet®), ranitidine (Zantac®)\]
- Anti-histamines \[e.g. fexofenadine (Allegra®), terfenadine (Seldane®), diphenhydramine (Benadryl®), desloratadine (Clarinex®)\], either routinely or during the 7 days before baseline urine and blood testing.
- Statins \[e.g. atorvastatin (Lipitor®), lovastatin (Altoprev®), pitavastatin (Livalo®), pravastatin (Pravachol®), rosuvastatin (Crestor®), simvastatin (Zocor®)\]
- Cannabinoids/Cannabis
- Corticosteroids including:
- Inhaled treatments such as beclomethasone (QVAR®), budesonide (Pulmicort®), ciclesonide (Alvesco®), fluticasone (Flovent®), mometasone (Asmanex Twisthaler®)
- Oral treatments such as Prednisone
- Injectables such as cortisone injections and IV treatments such as Humira®, Enbrel® and Remicade®
- Topical treatments such as hydrocortisone (Anusol®)
- Subjects with known allergy or intolerance to the test material ingredients (i.e. fish, soy)
- Subjects who consume fish more than twice per week
- Subjects who smoke tobacco and/or cannabis products
- Women who are pregnant or are planning to become pregnant or are lactating during the course of the study
- Subjects who have participated in a clinical trial (CT) within the past 3 months
- Subjects living in the same household as subjects that are currently enrolled within this study
- Subjects with diabetes (or taking Metformin), diagnosed arthritis, diagnosed chronic kidney disease, cancer, or with any apparent acute injury inflammation (e.g. torn rotator cuff, broken leg, severe skin abrasions).
- Subject who consume alcohol during the 12 hours before baseline urine and blood testing
Key Trial Info
Start Date :
February 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03862872
Start Date
February 1 2020
End Date
June 1 2021
Last Update
July 16 2020
Active Locations (1)
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1
Cornerstone Naturopathic Clinic, 14 Old School Rd, Upper Tantallon
Halifax, Nova Scotia, Canada, B3Z 2J6