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

Sponsors

Lead Sponsor: Bend Beauty Inc.

Source Bend Beauty Inc.
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 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

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.

Overall Status Withdrawn
Start Date 2020-02-01
Completion Date 2021-06-01
Primary Completion Date 2021-06-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Urinary 1-dehydrothromboxane B2 using The Chronic Inflammation Test Baseline to 90 days
Omega-3 Index Baseline to 90 days
Urinary 8-hydroxy-2' -deoxyguanosine (8- OHdG) Baseline to 90 days
Urinary 8-isoprostane Baseline to 90 days
Secondary Outcome
Measure Time Frame
Blood pressure Baseline to 90 days
Resting heart rate Baseline to 90 days
Height Baseline to 90 Days
Weight Baseline to 90 days
Body Mass Index (BMI) Baseline to 90 days
General health/function Baseline to 90 days
Physical activity rating Baseline to 90 days
Perceived health status Baseline to 90 days
Mental well-being/depression Baseline to 90 days
Skin Condition Baseline to 90 days
Condition
Intervention

Intervention Type: Dietary Supplement

Intervention Name: Anti-Aging Formula

Description: 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.

Arm Group Label: Anti-Aging Formula

Other Name: Bend Beauty's Anti-Aging Formula

Intervention Type: Dietary Supplement

Intervention Name: Control Fish Oil

Description: 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.

Arm Group Label: Control Fish Oil

Intervention Type: Other

Intervention Name: Inert Placebo

Description: The inert placebo is a soft gelatin capsule containing 1040 mg of corn oil.

Arm Group Label: Inert Placebo

Eligibility

Criteria:

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

Gender:

All

Gender Based:

Yes

Gender Description:

Male or Female

Minimum Age:

35 Years

Maximum Age:

65 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Ben Connolly, ND, BSc. Principal Investigator Cornerstone Naturopathic Clinic
Location
Facility: Cornerstone Naturopathic Clinic, 14 Old School Rd, Upper Tantallon
Location Countries

Canada

Verification Date

2019-12-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Anti-Aging Formula

Type: Experimental

Description: 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.

Label: Control Fish Oil

Type: Active Comparator

Description: 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.

Label: Inert Placebo

Type: Placebo Comparator

Description: 4 capsules daily of 1040 mg each of corn oil for 90 days.

Acronym BENCHMARK
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Phase IV, randomized, double-blind, placebo-controlled, three-arm, parallel intervention study

Primary Purpose: Treatment

Masking: Triple (Participant, Investigator, Outcomes Assessor)

Masking Description: Subject Code Numbers assigned to subjects using 400 randomly generated numbers ranging from 1-1000 are associated with all data generated in place of the subject name. Product Code Numbers on Test Materials, using 90 randomly generated numbers ranging from 1-99, are assigned by a Data Manager. All subsequent documentation will be labelled with the Product Code Number. Test material identity will not be shared with any participants within the trial [i.e. Subjects, Principal Investigator (PI), Clinical Research Monitor (CRM), Test Material Controller (TMC), Study Site Monitor & Quality Specialist (SM&QS), Data Analyst]. The only person who will be aware of the test material identity relative to any Product Code Number will be the Data Manager. Unmasking of the Product Code Numbers will be by the Data Manager, once statistical analysis is complete.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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