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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-29

Study Completion Date

2021-06-30

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.

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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.

Conditions

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Inflammation Skin Abnormalities Skin Pigment Inflammatory Response Skin Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Phase IV, randomized, double-blind, placebo-controlled, three-arm, parallel intervention study

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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.

Study Groups

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Anti-Aging Formula

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.

Group Type EXPERIMENTAL

Anti-Aging Formula

Intervention Type DIETARY_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 Oil

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.

Group Type ACTIVE_COMPARATOR

Control Fish Oil

Intervention Type DIETARY_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.

Inert Placebo

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

Group Type PLACEBO_COMPARATOR

Inert Placebo

Intervention Type OTHER

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

Interventions

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Anti-Aging Formula

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.

Intervention Type DIETARY_SUPPLEMENT

Control Fish Oil

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.

Intervention Type DIETARY_SUPPLEMENT

Inert Placebo

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

Intervention Type OTHER

Other Intervention Names

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Bend Beauty's Anti-Aging Formula

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

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

Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes