Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

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

14 de julio de 2020 actualizado por: 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.

Descripción general del estudio

Estado

Retirado

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

35 años a 65 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Suplemento dietético: 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.
Otros nombres:
  • Bend Beauty's Anti-Aging Formula
Comparador activo: 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.
Suplemento dietético: 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.
Comparador de placebos: Inert Placebo
4 capsules daily of 1040 mg each of corn oil for 90 days.
Otro: Inert Placebo
The inert placebo is a soft gelatin capsule containing 1040 mg of corn oil.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Urinary 1-dehydrothromboxane B2 using The Chronic Inflammation Test
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Blood pressure
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Bend Beauty Inc.

Investigadores

  • Investigador principal: Ben Connolly, ND, BSc., Cornerstone Naturopathic Clinic

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Anticipado)

1 de febrero de 2020

Finalización primaria (Anticipado)

1 de junio de 2021

Finalización del estudio (Anticipado)

1 de junio de 2021

Fechas de registro del estudio

Enviado por primera vez

27 de febrero de 2019

Primero enviado que cumplió con los criterios de control de calidad

1 de marzo de 2019

Publicado por primera vez (Actual)

5 de marzo de 2019

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

16 de julio de 2020

Última actualización enviada que cumplió con los criterios de control de calidad

14 de julio de 2020

Última verificación

1 de diciembre de 2019

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CT1801

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Anti-Aging Formula

Buscar ensayos similares

Patrocinadores y Colaboradores

Condiciones médicas

Intervenciones de drogas

CROs by country

CROs in Armenia

Condiciones

Enfermedades Raras

Intervenciones de drogas

Suplementos dietéticos

Patrocinador / Colaboradores

Localizaciones

3
Suscribir