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

Primary Purpose

Inflammation, Skin Abnormalities, Skin Pigment

Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Anti-Aging Formula
Control Fish Oil
Inert Placebo
Sponsored by
Bend Beauty Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammation focused on measuring 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

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Cornerstone Naturopathic Clinic, 14 Old School Rd, Upper Tantallon

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Anti-Aging Formula

Control Fish Oil

Inert Placebo

Arm 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.

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.

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

Outcomes

Primary Outcome Measures

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.
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
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.
Urinary 8-isoprostane
The concentration of 8-isoprostane in urine after treatment with Anti-Aging Formula, control fish oil and inert placebo.

Secondary Outcome Measures

Blood pressure
Blood pressure reported as mmHg (Systolic/Diastolic) after treatment with Anti-Aging Formula, control fish oil and inert placebo.
Resting heart rate
Resting heart rate in beats per minute after treatment with Anti-Aging Formula, control fish oil and inert placebo.
Height
Height in meters (m) after treatment with Anti-Aging Formula, control fish oil and inert placebo.
Weight
Weight in Kilograms (Kg) after treatment with Anti-Aging Formula, control fish oil and inert placebo.
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.
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
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.
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.
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.
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.

Full Information

First Posted
February 27, 2019
Last Updated
July 14, 2020
Sponsor
Bend Beauty Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03862872
Brief Title
Effects of Bend Beauty's Anti-Aging Formula on Inflammatory Markers
Acronym
BENCHMARK
Official Title
The Effects of Oral Supplementation With Bend Beauty's Anti-Aging Formula on Inflammatory Markers
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Altered research priorities
Study Start Date
February 2020 (Anticipated)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bend Beauty Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Phase IV, randomized, double-blind, placebo-controlled, three-arm, parallel intervention study
Masking
ParticipantInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anti-Aging Formula
Arm Type
Experimental
Arm 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.
Arm Title
Control Fish Oil
Arm Type
Active Comparator
Arm 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.
Arm Title
Inert Placebo
Arm Type
Placebo Comparator
Arm Description
4 capsules daily of 1040 mg each of corn oil for 90 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
Anti-Aging Formula
Other Intervention Name(s)
Bend Beauty's Anti-Aging Formula
Intervention 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Control Fish Oil
Intervention 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.
Intervention Type
Other
Intervention Name(s)
Inert Placebo
Intervention Description
The inert placebo is a soft gelatin capsule containing 1040 mg of corn oil.
Primary Outcome Measure Information:
Title
Urinary 1-dehydrothromboxane B2 using The Chronic Inflammation Test
Description
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.
Time Frame
Baseline to 90 days
Title
Omega-3 Index
Description
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
Time Frame
Baseline to 90 days
Title
Urinary 8-hydroxy-2' -deoxyguanosine (8- OHdG)
Description
The concentration of 8-OHdG in urine after treatment with Anti-Aging Formula, control fish oil and inert placebo.
Time Frame
Baseline to 90 days
Title
Urinary 8-isoprostane
Description
The concentration of 8-isoprostane in urine after treatment with Anti-Aging Formula, control fish oil and inert placebo.
Time Frame
Baseline to 90 days
Secondary Outcome Measure Information:
Title
Blood pressure
Description
Blood pressure reported as mmHg (Systolic/Diastolic) after treatment with Anti-Aging Formula, control fish oil and inert placebo.
Time Frame
Baseline to 90 days
Title
Resting heart rate
Description
Resting heart rate in beats per minute after treatment with Anti-Aging Formula, control fish oil and inert placebo.
Time Frame
Baseline to 90 days
Title
Height
Description
Height in meters (m) after treatment with Anti-Aging Formula, control fish oil and inert placebo.
Time Frame
Baseline to 90 Days
Title
Weight
Description
Weight in Kilograms (Kg) after treatment with Anti-Aging Formula, control fish oil and inert placebo.
Time Frame
Baseline to 90 days
Title
Body Mass Index (BMI)
Description
Weight and height will be combined to calculate BMI as kg/m2 after treatment with Anti-Aging Formula, control fish oil and inert placebo.
Time Frame
Baseline to 90 days
Title
General health/function
Description
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
Time Frame
Baseline to 90 days
Title
Physical activity rating
Description
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.
Time Frame
Baseline to 90 days
Title
Perceived health status
Description
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.
Time Frame
Baseline to 90 days
Title
Mental well-being/depression
Description
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.
Time Frame
Baseline to 90 days
Title
Skin Condition
Description
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.
Time Frame
Baseline to 90 days

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Male or Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ben Connolly, ND, BSc.
Organizational Affiliation
Cornerstone Naturopathic Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cornerstone Naturopathic Clinic, 14 Old School Rd, Upper Tantallon
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3Z 2J6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28884844
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.
Results Reference
background

Learn more about this trial

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

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