Effects of Bend Beauty's Anti-Aging Formula on Inflammatory Markers (BENCHMARK)
2020년 7월 14일 업데이트: 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.
연구 개요
상태
빼는
상세 설명
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.
연구 유형
중재적
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Nova Scotia
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Halifax, Nova Scotia, 캐나다, B3Z 2J6
- Cornerstone Naturopathic Clinic, 14 Old School Rd, Upper Tantallon
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
35년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
다른 이름들:
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활성 비교기: 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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위약 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Urinary 1-dehydrothromboxane B2 using The Chronic Inflammation Test
기간: 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
기간: 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)
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Blood pressure
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 수석 연구원: Ben Connolly, ND, BSc., Cornerstone Naturopathic Clinic
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (예상)
2020년 2월 1일
기본 완료 (예상)
2021년 6월 1일
연구 완료 (예상)
2021년 6월 1일
연구 등록 날짜
최초 제출
2019년 2월 27일
QC 기준을 충족하는 최초 제출
2019년 3월 1일
처음 게시됨 (실제)
2019년 3월 5일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 7월 16일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 7월 14일
마지막으로 확인됨
2019년 12월 1일
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- CT1801
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
염증에 대한 임상 시험
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Actavis Inc.Watson Laboratories, Inc.완전한세균성 질염 | 평가 및 기록할 징후 및 증상은 다음과 같습니다. | 질 분비물의 색, 냄새 및 일관성 | 외음부 가려움증 및 자극(주관적) 없음, 경미함, 보통 또는 심함 | Vulvovaginal Inflammation (Objective) 부재, 경증, 중등도 또는 중증미국, 도미니카 공화국, 푸에르토 리코
Anti-Aging Formula에 대한 임상 시험
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Endourage, LLC완전한
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Endourage, LLC모병긴 COVID | 긴 Covid19 | 포스트 급성 COVID-19 | 장거리 COVID | 장거리 COVID-19 | COVID-19 후 증후군미국
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Peking University Third Hospital모병
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University Hospital, Bordeaux완전한
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U.S. Army Medical Research and Development Command더 이상 사용할 수 없음중증급성호흡기증후군 코로나바이러스 2미국, 독일, 아프가니스탄, 지부티, 괌, 이라크, 일본, 쿠웨이트