Effects of Bend Beauty's Anti-Aging Formula on Inflammatory Markers

Bend Beauty Inc.

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Conditions

Inflammation Skin Abnormalities Skin Pigment Inflammatory Response Skin Inflammation

Interventions

Anti-Aging FormulaDIETARY_SUPPLEMENT

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.

Control Fish OilDIETARY_SUPPLEMENT

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.

Eligibility

Sex: ALLMin age: 35 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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: 1. Subjects who are unwilling to provide blood and urine samples during the initial and subsequent test points. 2. 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 3. 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.) 4. Subjects taking: 1. 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. 2. H2 antagonist/blockers \[e.g. cimetidine (Tagamet®), ranitidine (Zantac®)\] 3. 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. 4. Statins \[e.g. atorvastatin (Lipitor®), lovastatin (Altoprev®), pitavastatin (Livalo®), pravastatin (Pravachol®), rosuvastatin (Crestor®), simvastatin (Zocor®)\] 5. Cannabinoids/Cannabis 6. 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®) 5. Subjects with known allergy or intolerance to the test material ingredients (i.e. fish, soy) 6. Subjects who consume fish more than twice per week 7. Subjects who smoke tobacco and/or cannabis products 8. Women who are pregnant or are planning to become pregnant or are lactating during the course of the study 9. Subjects who have participated in a clinical trial (CT) within the past 3 months 10. Subjects living in the same household as subjects that are currently enrolled within this study 11. 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). 12. Subject who consume alcohol during the 12 hours before baseline urine and blood testing

Locations (1)

Cornerstone Naturopathic Clinic, 14 Old School Rd, Upper Tantallon

Halifax, Nova Scotia, Canada

Outcomes

Primary Outcomes

Urinary 1-dehydrothromboxane B2 using The Chronic Inflammation Test

The concentration of 1-dehydrothromboxane B2 in urine using The Chronic Inflammation Test (https://chronicinflammationtest.com) after treatment with Anti-Aging Formula, control fish oil and inert placebo.