Effects of Bend Beauty's Anti-Aging Formula on Inflammatory Markers (BENCHMARK)
The Effects of Oral Supplementation With Bend Beauty's Anti-Aging Formula on Inflammatory Markers
調査の概要
状態
詳細な説明
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.
研究の種類
段階
- 適用できない
連絡先と場所
研究場所
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Nova Scotia
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Halifax、Nova Scotia、カナダ、B3Z 2J6
- Cornerstone Naturopathic Clinic, 14 Old School Rd, Upper Tantallon
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的: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.
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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.
他の名前:
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アクティブコンパレータ: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.
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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.
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プラセボコンパレーター:Inert Placebo
4 capsules daily of 1040 mg each of corn oil for 90 days.
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The inert placebo is a soft gelatin capsule containing 1040 mg of corn oil.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Urinary 1-dehydrothromboxane B2 using The Chronic Inflammation Test
時間枠:Baseline to 90 days
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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.
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Baseline to 90 days
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Omega-3 Index
時間枠:Baseline to 90 days
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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
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Baseline to 90 days
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Urinary 8-hydroxy-2' -deoxyguanosine (8- OHdG)
時間枠:Baseline to 90 days
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The concentration of 8-OHdG in urine after treatment with Anti-Aging Formula, control fish oil and inert placebo.
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Baseline to 90 days
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Urinary 8-isoprostane
時間枠:Baseline to 90 days
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The concentration of 8-isoprostane in urine after treatment with Anti-Aging Formula, control fish oil and inert placebo.
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Baseline to 90 days
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Blood pressure
時間枠:Baseline to 90 days
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Blood pressure reported as mmHg (Systolic/Diastolic) after treatment with Anti-Aging Formula, control fish oil and inert placebo.
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Baseline to 90 days
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Resting heart rate
時間枠:Baseline to 90 days
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Resting heart rate in beats per minute after treatment with Anti-Aging Formula, control fish oil and inert placebo.
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Baseline to 90 days
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Height
時間枠:Baseline to 90 Days
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Height in meters (m) after treatment with Anti-Aging Formula, control fish oil and inert placebo.
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Baseline to 90 Days
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Weight
時間枠:Baseline to 90 days
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Weight in Kilograms (Kg) after treatment with Anti-Aging Formula, control fish oil and inert placebo.
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Baseline to 90 days
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Body Mass Index (BMI)
時間枠:Baseline to 90 days
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Weight and height will be combined to calculate BMI as kg/m2 after treatment with Anti-Aging Formula, control fish oil and inert placebo.
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Baseline to 90 days
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General health/function
時間枠:Baseline to 90 days
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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
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Baseline to 90 days
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Physical activity rating
時間枠:Baseline to 90 days
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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.
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Baseline to 90 days
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Perceived health status
時間枠:Baseline to 90 days
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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.
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Baseline to 90 days
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Mental well-being/depression
時間枠:Baseline to 90 days
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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.
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Baseline to 90 days
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Skin Condition
時間枠:Baseline to 90 days
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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.
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Baseline to 90 days
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Ben Connolly, ND, BSc.、Cornerstone Naturopathic Clinic
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- CT1801
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
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Anti-Aging Formulaの臨床試験
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Endourage, LLC募集長い COVID | ロング Covid19 | ポスト急性COVID-19 | 長距離COVID | 長距離COVID-19 | ポスト急性COVID-19症候群アメリカ
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Advanced Dermatology完了
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University of Georgia募集メッセージの露出 (順序: レギュラーの次にフレーバー) | メッセージ露出 (順序: フレーバーからレギュラー) | メッセージの露出なし (制御条件)アメリカ
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