Title
Effects of Bend Beauty's Anti-Aging Formula on Inflammatory Markers
The Effects of Oral Supplementation With Bend Beauty's Anti-Aging Formula on Inflammatory Markers
Phase
N/ALead Sponsor
Bend Beauty Inc.Study Type
InterventionalStatus
WithdrawnIndication/Condition
Skin Abnormalities Skin Pigment Inflammatory Response Skin Inflammation ...Intervention/Treatment
Anti-Aging Formula [eicosapentanoic acid (114096), docosahexaenoic acid (113984)] Control Fish Oil ...Study Participants
0This 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 Beauty's Anti-Aging Formula, fish oil control or inert placebo for 90 days, with testing points at baseline, 30, 60, and 90 days.
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 Beauty's Anti-Aging Formula, fish oil control or inert placebo for 90 days, with testing points at baseline, 30, 60, and 90 days.
Subjects will be preselected through a Subject Eligibility Screening (SES) against defined inclusion and exclusion criteria for entry into the trial. Eligible participants will be tested using the Chronic Inflammation Test for urinary 11-dehydrothromboxane B2 (https://chronicinflammationtest.com) and the Omega-3 Index Test for eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) in red blood cells (RBC) (https://omegaquant.com ), to confirm possible presence of chronic inflammation. If these test results meet a defined limit, participants will be enrolled in the trial.
A number of assessments will be conducted before and after treatment.
Anti-Aging Formula contains 1050 mg of EPA and 350 mg of DHA from anchovies, sardines, and/or mackerel whole body oil, 120 mg of GLA from Borage (Borago officianalis) seeds, 2.5 mg of zeaxanthin from Capsicum annuum L. fruit, 5 mg of lutein from Tagetes erecta flower, and 25 μg (1000 IU) of vitamin D3 (cholecalciferol) from lanolin per 4 capsule daily dose. This dosage form is the same as is commercially marketed in Canada under license Natural Product Number (NPN) 80077254.
The control fish oil is a soft gelatin capsule containing 1,106 mg of triglyceride fish oil from anchovies, sardines, and/or mackerel whole body oil. A four capsule per day dose provides 816 mg EPA and 572 mg DHA, which is only slightly less EPA+DHA than is provided within a four capsule per day dose of Anti-Aging Formula. This minor difference would not be expected to alter clinical outcomes.
The inert placebo is a soft gelatin capsule containing 1040 mg of corn oil.
4 capsules daily of high-EPA fish oil, borage oil, zeaxanthin, lutein and vitamin D providing 1050 mg of Eicosapentaenoic acid (EPA) and 350 mg of Docosahexaenoic acid (DHA), 120 mg of Gamma-linolenic acid (GLA), 2.5 mg of zeaxanthin, 5 mg of lutein and 25 μg (1000 IU) of vitamin D3 for 90 days.
4 capsules daily of 1,106 mg each of triglyceride fish oil from anchovies, sardines, and/or mackerel whole body oil providing 816 mg EPA and 572 mg DHA total for 90 days.
4 capsules daily of 1040 mg each of corn oil for 90 days.
Inclusion Criteria: 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 Criteria: 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
