The Effects of Oral Supplementation With Bend Beauty's Anti-Aging Formula on Inflammatory Markers
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Omega-3 Index
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Subject Code Numbers assigned to subjects using 400 randomly generated numbers ranging from 1-1000 are associated with all data generated in place of the subject name.
Product Code Numbers on Test Materials, using 90 randomly generated numbers ranging from 1-99, are assigned by a Data Manager. All subsequent documentation will be labelled with the Product Code Number. Test material identity will not be shared with any participants within the trial [i.e. Subjects, Principal Investigator (PI), Clinical Research Monitor (CRM), Test Material Controller (TMC), Study Site Monitor & Quality Specialist (SM&QS), Data Analyst]. The only person who will be aware of the test material identity relative to any Product Code Number will be the Data Manager.
Unmasking of the Product Code Numbers will be by the Data Manager, once statistical analysis is complete.
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Anti-Aging Formula (Dietary Supplement)
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.
干预措施: Control Fish Oil (Dietary Supplement)
Inert Placebo
4 capsules daily of 1040 mg each of corn oil for 90 days.
干预措施: Inert Placebo (Other)
结局指标
主要结局
Omega-3 Index
时间窗: 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
Urinary 8-hydroxy-2' -deoxyguanosine (8- OHdG)
时间窗: Baseline to 90 days
The concentration of 8-OHdG in urine after treatment with Anti-Aging Formula, control fish oil and inert placebo.
Urinary 1-dehydrothromboxane B2 using The Chronic Inflammation Test
时间窗: 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.
Urinary 8-isoprostane
时间窗: Baseline to 90 days
The concentration of 8-isoprostane in urine after treatment with Anti-Aging Formula, control fish oil and inert placebo.
次要结局
- General health/function(Baseline to 90 days)
- Blood pressure(Baseline to 90 days)
- Physical activity rating(Baseline to 90 days)
- Resting heart rate(Baseline to 90 days)
- Height(Baseline to 90 Days)
- Weight(Baseline to 90 days)
- Perceived health status(Baseline to 90 days)
- Body Mass Index (BMI)(Baseline to 90 days)
- Skin Condition(Baseline to 90 days)
- Mental well-being/depression(Baseline to 90 days)