Clinical trial NCT03862872: Effects of Bend Beauty's Anti-Aging Formula on Inflammatory Markers
Official title: The Effects of Oral Supplementation With Bend Beauty's Anti-Aging Formula on Inflammatory Markers
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Inflammation
Skin Abnormalities
Skin Pigment
Inflammatory Response
Skin Inflammation
Keywords: Inflammation
Skin
UV-light
Inflammatory markers
Eicosapentaenoic acid (EPA)
Docosahexaenoic acid (DHA)
Fish Oil
Gamma-linolenic acid (GLA)
Borage oil
Vitamin D
Zeaxanthin
Lutein
Omega-3 Index
Chronic Inflammation Test
11-dehydrothromboxane B2
8-hydroxy-2' -deoxyguanosine (8- OHdG)
8-isoprostane
Lead sponsor: Bend Beauty Inc.
Sponsor class: INDUSTRY
First posted: 2019-03-05
Enrollment: 0
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase IV, randomized, double-blind, placebo-controlled, three-arm, parallel intervention study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Urinary 1-dehydrothromboxane B2 using The Chronic Inflammation Test
timeFrame: Baseline to 90 days
measure: Omega-3 Index
timeFrame: Baseline to 90 days
measure: Urinary 8-hydroxy-2' -deoxyguanosine (8- OHdG)
timeFrame: Baseline to 90 days
measure: Urinary 8-isoprostane
timeFrame: Baseline to 90 days
Secondary outcomes:
measure: Blood pressure
timeFrame: Baseline to 90 days
measure: Resting heart rate
timeFrame: Baseline to 90 days
measure: Height
timeFrame: Baseline to 90 Days
measure: Weight
timeFrame: Baseline to 90 days
measure: Body Mass Index (BMI)
timeFrame: Baseline to 90 days
measure: General health/function
timeFrame: Baseline to 90 days
measure: Physical activity rating
timeFrame: Baseline to 90 days
measure: Perceived health status
timeFrame: Baseline to 90 days
measure: Mental well-being/depression
timeFrame: Baseline to 90 days
measure: Skin Condition
timeFrame: Baseline to 90 days
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Cornerstone Naturopathic Clinic, 14 Old School Rd, Upper Tantallon
state: Nova Scotia
Study officials:
affiliation: Cornerstone Naturopathic Clinic
name: Ben Connolly, ND, BSc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Morse NL, Reid AJ, St-Onge M. An open-label clinical trial assessing the efficacy and safety of Bend Skincare Anti-Aging Formula on minimal erythema dose in skin. Photodermatol Photoimmunol Photomed. 2018 Mar;34(2):152-161. doi: 10.1111/phpp.12350. Epub 2017 Oct 11.