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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effects of Oral Supplementation With Bend Beauty's Anti-Aging Formula on Inflammatory Markers

Conditions
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Inflammation, Skin Abnormalities, Skin Pigment, Inflammatory Response, Skin Inflammation

Intervention / Treatment
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* Dietary Supplement: Anti-Aging Formula
* Dietary Supplement: Control Fish Oil
* Other: Inert Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Phase IV, randomized, double-blind, placebo-controlled, three-arm, parallel intervention study
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anti-Aging Formula<br>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. | Dietary Supplement: Anti-Aging Formula<br>* 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.<br>* Other names: Bend Beauty's Anti-Aging Formula;|
| Active Comparator: Control Fish Oil<br>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. | Dietary Supplement: Control Fish Oil<br>* 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.<br>|
| Placebo Comparator: Inert Placebo<br>4 capsules daily of 1040 mg each of corn oil for 90 days. | Other: Inert Placebo<br>* The inert placebo is a soft gelatin capsule containing 1040 mg of corn oil.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline to 90 days | 
| Omega-3 Index | The concentration of EPA+DHA expressed as the Omega-3 index (https://omegaquant.com), after treatment with Anti-Aging Formula, control fish oil and inert placebo | Baseline to 90 days | 
| Urinary 8-hydroxy-2' -deoxyguanosine (8- OHdG) | The concentration of 8-OHdG in urine after treatment with Anti-Aging Formula, control fish oil and inert placebo. | Baseline to 90 days | 
| Urinary 8-isoprostane | The concentration of 8-isoprostane in urine after treatment with Anti-Aging Formula, control fish oil and inert placebo. | Baseline to 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Blood pressure reported as mmHg (Systolic/Diastolic) after treatment with Anti-Aging Formula, control fish oil and inert placebo. | Baseline to 90 days | 
| Resting heart rate | Resting heart rate in beats per minute after treatment with Anti-Aging Formula, control fish oil and inert placebo. | Baseline to 90 days | 
| Height | Height in meters (m) after treatment with Anti-Aging Formula, control fish oil and inert placebo. | Baseline to 90 Days | 
| Weight | Weight in Kilograms (Kg) after treatment with Anti-Aging Formula, control fish oil and inert placebo. | Baseline to 90 days | 
| Body Mass Index (BMI) | Weight and height will be combined to calculate BMI as kg/m2 after treatment with Anti-Aging Formula, control fish oil and inert placebo. | Baseline to 90 days | 
| General health/function | Subjective assessment of general health/function using an in-house designed questionnaire after treatment with Anti-Aging Formula, control fish oil and inert placebo. The questionnaire consists of a list of 27 questions with answers on a scale from 0-4 that cover a variety of health indicators including pain, task oriented performance, mental and emotional well-being, appetite, etc. The resulting score defines General Health/Function as Excellent 81-108 Good 54-80 Poor 27-53 Extremely poor 0-26 | Baseline to 90 days | 
| Physical activity rating | Subjective assessment of physical activity using an in-house designed questionnaire after treatment with Anti-Aging Formula, control fish oil and inert placebo. Results are expressed as how many days per week (0-7) that the Subject exercised to a defined amount, where a greater number of days is considered better. | Baseline to 90 days | 
| Perceived health status | Subjective assessment of perceived health using an in-house designed questionnaire after treatment with Anti-Aging Formula, control fish oil and inert placebo. The results are expressed as the subjects' perceived health (degrees of good or bad) on the day that the questionnaire is completed using a scale of 0-100 where 0 is the worst imaginable health and 100 is the best imaginable health. | Baseline to 90 days | 
| Mental well-being/depression | Subjective assessment of mental well-being/depression using the Patient Health Questionnaire-9 after treatment with Anti-Aging Formula, control fish oil and inert placebo. The Patient Health Questionnaire-9 is available in the public domain, and is employed to capture data more focused on mental health indicators of depression. It is a version of the PRIME-MD diagnostic instrument for common mental disorders, which scores each of the nine DSM-IV criteria as 0 (not at all) to 3 (nearly every day). It has been validated for use in primary care to monitor severity of depression and response to treatment. Results are presented as a score ranging from 0-27, where 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, and 20-27 is severe depression. | Baseline to 90 days | 
| Skin Condition | Subjective assessment of skin condition using Observ 520 Skin Analysis (http://www.observ.uk.com/) after treatment with Anti-Aging Formula, control fish oil and inert placebo. Observ 520 Skin Analysis measures skin condition in the epidermal and dermal layers using skin fluorescence and polarized light illumination technology to produce visual indicators of skin's condition.The technology allows overlay of one photo on top of another to enable comparative changes before and after treatment. Numerical data will be created by comparing before and after treatment photos and assigning the descriptors: improved, unchanged, or worsened that correspond to the values +1, 0, or -1, respectively. The average numerical value from each of the three treatment arms will then be calculated and compared, which will be used as quantitative measures of the treatments' effects on skin condition. | Baseline to 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lutein, Inflammation, Skin, UV-light, Inflammatory markers, Eicosapentaenoic acid (EPA), Docosahexaenoic acid (DHA), Fish Oil, Gamma-linolenic acid (GLA), Borage oil, Vitamin D, Zeaxanthin, Omega-3 Index, Chronic Inflammation Test, 11-dehydrothromboxane B2, 8-hydroxy-2' -deoxyguanosine (8- OHdG), 8-isoprostane