NCT03862872

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 5, 2019

Completed
11 months until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

July 16, 2020

Status Verified

December 1, 2019

Enrollment Period

1.3 years

First QC Date

February 27, 2019

Last Update Submit

July 14, 2020

Conditions

InflammationSkin AbnormalitiesSkin PigmentInflammatory ResponseSkin Inflammation

Keywords

InflammationSkinUV-lightInflammatory markersEicosapentaenoic acid (EPA)Docosahexaenoic acid (DHA)Fish OilGamma-linolenic acid (GLA)Borage oilVitamin DZeaxanthinLuteinOmega-3 IndexChronic Inflammation Test11-dehydrothromboxane B28-hydroxy-2' -deoxyguanosine (8- OHdG)8-isoprostane

Outcome Measures

Primary Outcomes (4)

  • 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.

    Baseline to 90 days

  • 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

    Baseline to 90 days

  • 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.

    Baseline to 90 days

  • Urinary 8-isoprostane

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

    Baseline to 90 days

Secondary Outcomes (10)

  • 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

  • +5 more secondary outcomes

Study Arms (3)

Anti-Aging Formula

EXPERIMENTAL

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.

Dietary Supplement: Anti-Aging Formula

Control Fish Oil

ACTIVE COMPARATOR

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.

Dietary Supplement: Control Fish Oil

Inert Placebo

PLACEBO COMPARATOR

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

Other: Inert Placebo

Interventions

Anti-Aging FormulaDIETARY_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.

Also known as: Bend Beauty's Anti-Aging Formula
Anti-Aging Formula
Control Fish OilDIETARY_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.

Control Fish Oil
Inert PlaceboOTHER

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

Inert Placebo

Eligibility Criteria

Age35 Years - 65 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsMale or Female
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cornerstone Naturopathic Clinic, 14 Old School Rd, Upper Tantallon

Halifax, Nova Scotia, B3Z 2J6, Canada

Location

Related Publications (1)

  • 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.

    PMID: 28884844BACKGROUND

MeSH Terms

Conditions

InflammationSkin AbnormalitiesPigmentation DisordersDermatitis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Ben Connolly, ND, BSc.

    Cornerstone Naturopathic Clinic

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Phase IV, randomized, double-blind, placebo-controlled, three-arm, parallel intervention study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2019

First Posted

March 5, 2019

Study Start

February 1, 2020

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

July 16, 2020

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)