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

14 juli 2020 uppdaterad av: Bend Beauty Inc.

The Effects of Oral Supplementation With Bend Beauty's Anti-Aging Formula on Inflammatory Markers

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.

Studieöversikt

Status

Indragen

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Kanada
    • Nova Scotia
      • Halifax, Nova Scotia, Kanada, B3Z 2J6
        • Cornerstone Naturopathic Clinic, 14 Old School Rd, Upper Tantallon

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

35 år till 65 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Trippel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Kosttillskott: 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.
Andra namn:
  • Bend Beauty's Anti-Aging Formula
Aktiv komparator: 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.
Kosttillskott: 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.
Placebo-jämförare: Inert Placebo
4 capsules daily of 1040 mg each of corn oil for 90 days.
Övrig: Inert Placebo
The inert placebo is a soft gelatin capsule containing 1040 mg of corn oil.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Urinary 1-dehydrothromboxane B2 using The Chronic Inflammation Test
Tidsram: Baseline to 90 days
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
Tidsram: Baseline to 90 days
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)
Tidsram: Baseline to 90 days
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
Tidsram: Baseline to 90 days
The concentration of 8-isoprostane in urine after treatment with Anti-Aging Formula, control fish oil and inert placebo.
Baseline to 90 days

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Blood pressure
Tidsram: Baseline to 90 days
Blood pressure reported as mmHg (Systolic/Diastolic) after treatment with Anti-Aging Formula, control fish oil and inert placebo.
Baseline to 90 days
Resting heart rate
Tidsram: Baseline to 90 days
Resting heart rate in beats per minute after treatment with Anti-Aging Formula, control fish oil and inert placebo.
Baseline to 90 days
Height
Tidsram: Baseline to 90 Days
Height in meters (m) after treatment with Anti-Aging Formula, control fish oil and inert placebo.
Baseline to 90 Days
Weight
Tidsram: Baseline to 90 days
Weight in Kilograms (Kg) after treatment with Anti-Aging Formula, control fish oil and inert placebo.
Baseline to 90 days
Body Mass Index (BMI)
Tidsram: Baseline to 90 days
Weight and height will be combined to calculate BMI as kg/m2 after treatment with Anti-Aging Formula, control fish oil and inert placebo.
Baseline to 90 days
General health/function
Tidsram: Baseline to 90 days

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
Baseline to 90 days
Physical activity rating
Tidsram: Baseline to 90 days
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.
Baseline to 90 days
Perceived health status
Tidsram: Baseline to 90 days
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.
Baseline to 90 days
Mental well-being/depression
Tidsram: Baseline to 90 days
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.
Baseline to 90 days
Skin Condition
Tidsram: Baseline to 90 days
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.
Baseline to 90 days

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Bend Beauty Inc.

Utredare

  • Huvudutredare: Ben Connolly, ND, BSc., Cornerstone Naturopathic Clinic

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Förväntat)

1 februari 2020

Primärt slutförande (Förväntat)

1 juni 2021

Avslutad studie (Förväntat)

1 juni 2021

Studieregistreringsdatum

Först inskickad

27 februari 2019

Först inskickad som uppfyllde QC-kriterierna

1 mars 2019

Första postat (Faktisk)

5 mars 2019

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

16 juli 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

14 juli 2020

Senast verifierad

1 december 2019

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • CT1801

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

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Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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