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

Bend Beauty

Status: Withdrawn

Conditions: Skin Inflammation; Inflammation; Inflammatory Response; Skin Abnormalities; Skin Pigment

Treatments: Other: Inert Placebo; Dietary Supplement: Control Fish Oil; Dietary Supplement: Anti-Aging Formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT03862872

CT1801

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 35 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 3 patient groups, including a placebo group

Anti-Aging Formula

Experimental group

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.

Treatment:

Dietary Supplement: Anti-Aging Formula

Control Fish Oil

Active Comparator group

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.

Treatment:

Dietary Supplement: Control Fish Oil

Inert Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Inert Placebo