An interventional study of Anti-Aging Formula and Control Fish Oil in Inflammation, Skin Abnormalities and Skin Pigment, sponsored by Bend Beauty Inc.. Withdrawn at 1 site in Canada. Open to participants aged 35 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-16.
Sponsored by Bend Beauty Inc. · Not applicable, Interventional, and Treatment
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.
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.
39 studies on the registry are indexed under Skin Abnormalities; 7 are open to participants now.
Browse Skin Abnormalities studies →This is the only study on the registry with Bend Beauty Inc. as lead sponsor.
Compared within Skin Abnormalities, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Inflammation. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Subjects taking:
including:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
4 capsules daily of 1040 mg each of corn oil for 90 days.
Other: Inert Placebo
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
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.
The inert placebo is a soft gelatin capsule containing 1040 mg of corn oil.
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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 90 days
Blood pressure
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
Resting heart rate
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
Height
Height in meters (m) after treatment with Anti-Aging Formula, control fish oil and inert placebo.
Time frame: Baseline to 90 Days
Weight
Weight in Kilograms (Kg) after treatment with Anti-Aging Formula, control fish oil and inert placebo.
Time frame: Baseline to 90 days
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.
Time frame: Baseline to 90 days
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
Time frame: Baseline to 90 days
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.
Time frame: Baseline to 90 days
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.
Time frame: Baseline to 90 days
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.
Time frame: Baseline to 90 days
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.
Time frame: Baseline to 90 days
Plan to share: No
Start is estimated for Feb 2020; primary completion for Jun 2021, 16 months later.
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This study is withdrawn, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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