NCT04269876终止不适用
A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effects of a Specialized Pro-Resolving Mediator Formulation on Inflammation in Individuals Who Are Overweight to Mildly Obese and Otherwise Generally Healthy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Assessment of the mean or median change in high sensitivity C-reactive protein (hs-CRP) relative to baseline
研究概览
简要总结
To assess the efficacy and safety of a Marine Lipid Oil Concentrate formulation on inflammatory biomarkers and overall well-being in male and female subjects who are overweight to mildly obese, but otherwise generally healthy.
详细描述
This is a double-blind randomized, placebo-controlled study to evaluate the effects of a Marine Lipid Oil Concentrate formulation on inflammation.. Each subject will receive a specific dose of the study product (A) to be taken once daily with a specific dose of the study product (B) to be taken once daily for a total of 60 days.
Participants will receive questionnaires, assessments, blood tests, vital signs and a body composition analysis.
The primary objective is the assessment of the change in the blood levels of hs-CRP in response to the Marine Lipid Oil Concentrate formulation relative to screening/baseline compared to placebo.
The secondary objective is the assessment of the change in the in response to the Marine Lipid Oil Concentrate formulation relative to screening/baseline compared to placebo for Interleukin-6 (IL-6), Tumor necrosis factor (TNF-alpha), Erythrocyte Sedimentation Rate (ESR), Fibrinogen Activity, B-type natriuretic peptide (BNP), Ferritin, Blood lipid levels (Total Cholesterol, High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Triglycerides), Short Form-36 (SF-36) Health Survey scores and the Medical Symptoms Questionnaire
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ambulatory, male or female, 35-75 years of age
- •A BMI of 23-34.9
- •hs-CRP level of 1-7.5 mg/L
- •Generally healthy and having no significant difficulty with digestion or absorption of food
- •Has been generally weight stable for the past six months (+/- 6 lbs.)
- •Willing and able to give written informed consent
- •Clearly understands the procedures and study requirements
- •Willing and able to comply with all study procedures, including following the recommendations to maintain their usual diet and regular activity, as per protocol
- •Able to communicate, including reading, in English
- •Have not taken any nutritional supplements that may contain any of the components of the study product for a minimum of 14 days before Screening/baseline
排除标准
- •Having smoked any cigarette, electronic cigarette, cigar, pipe, or used a recreational drug as well as any product containing cannabidiol (CBD) and tetrahydrocannabinol in the past 30 days.
- •Donated blood within 30 days before Screening/baseline
- •Inability to provide a venous blood sample
- •Participation in another study within 30 days before Screening/baseline
- •Being pregnant or planning on becoming pregnant during study participation; or breast feeding
- •History of allergy or sensitivity to any component of the study products
- •Currently taking a lipid lowering medication or dietary supplement
- •Currently taking a medication or dietary supplement specifically for pain or inflammation including curcumin and unwilling to washout (i.e., stop taking) for 14 days before Screening/baseline
- •Currently taking or having taken a fish oil, krill oil, omega-3 supplement and omega-3 prescription drugs within the past 3 months before Screening/baseline
- •Currently taking or having taken pain medications or anti-inflammatory medication(s) (e.g., aspirin, NSAIDs, Cyclooxygenase-2 (COX-2) inhibitors, and corticosteroids) within 14 days before Screening/baseline or in the judgment of the Study Investigator/Sub-I would not preclude participation in the study
- •Having been diagnosed, received medical treatment, or taking medication daily for the following medical condition(s):
- •Acute or chronic inflammatory or autoimmune disease (including rheumatoid arthritis, system lupus erythematosus, ankylosing spondylitis, Sjögren's syndrome, polymyalgia rheumatica, inflammatory bowel disease, and psoriatic arthritis)
- •Presence of active or recurring clinically significant conditions as follows:
- •Diabetes mellitus or other endocrine disease
- •Acute infection
- •Active periodontal disease
- •Cardiovascular disease including heart and blood vessel disease, arrhythmia, heart attack, stroke, or heart valve problem
- •Gastrointestinal disease including gallbladder problems, gallstones, or biliary tract obstruction
- •Thyroid disease (unless on a stable dose of medication for 3 months before screening and unlikely to change medication or dose during the study)
- •Hypertension (unless on a stable dose of medication for 3 months screening and unlikely to change medication or dose during the study)
- •Neurologic condition/disease
- •Cancer (unless skin cancer other than melanoma which has been treated > 3 years before Screening/baseline)
- •Liver, pancreatic, and kidney disease
- •Pulmonary disease
- •Blood coagulation disorder or other hematologic disease
- •Other condition or medication use that would preclude participation in the study in the judgment of the Investigator/Sub-I
- •Currently taking any medications or treatment for a psychiatric disorder (bipolar disorder,manic disorder, schizophrenia, apathetic [inherited] disorder), that include antidepressant drugs, including selective serotonin reuptake inhibitors (SSRIs), tricyclic and atypical antidepressants; benzodiazepines; central nervous system (CNS) depressants, dextromethorphan, meperidine, monoamine oxidase inhibitors (MAOIs); pentazocine, phenothiazines, and tramadol. These may preclude participation in the study dependent on the judgment of the Investigator/Sub-I.
- •Currently taking or having taken within the 30 days before Screening/baseline any hormone replacement therapy (including dehydroepiandrosterone (DHEA), estrogen, progesterone, or testosterone; except those utilized as a method of birth control and which have been taken for > 3 months, with no anticipated change for the duration of the study)
- •Having had a surgical procedure or having an internal medical device which, in the judgment of the Study Investigator/Sub-I, would preclude participation in the study
- •Having abnormal screening laboratory test values including bilirubin > 2.5 x upper limit of normal (ULN), aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) and alanine transaminase (ALT)/serum glutamic-pyruvic transaminase (SGPT) > 2.5 x ULN, serum creatinine > 1.5 mg/dL, blood glucose < 85 mg/dL or > 110 mg/dL, hs-CRP < 1.0 mg/L or > 5 mg/L, or other lab test result(s) that would preclude study participation in the judgement of the Study Investigator/Sub-I
- •Having blood pressure readings at Screening/baseline > 140 systolic or > 90 diastolic on two consecutive readings unless permitted to proceed to the next visit in the judgment of the Study Investigator/Sub-I
- •Currently consumes more than 7 standard alcoholic drinks per week for women and 14 drinks per week for men (a standard alcoholic drink is defined as one bottle/can of beer, one glass of wine, or one ounce of hard liquor)
- •Unable or unwilling to avoid consuming grapefruit juice or fresh grapefruit, Seville oranges, and tangelos
- •History of known or suspected substance abuse (e.g., alcohol, opiates, benzodiazepines or amphetamines).
- •Having any other circumstance that precludes study participation in the judgment of the Study Investigator/Sub-I, including use of other nutritional supplements, which will be evaluated on a case-by-case basis.
结局指标
主要结局
Assessment of the mean or median change in high sensitivity C-reactive protein (hs-CRP) relative to baseline
时间窗: 60 days
Mean or median change in high sensitivity C-reactive protein (hs-CRP) from baseline to Day 60
次要结局
- Assessment of the mean or median change in Interleukin-6 (IL-6) relative to baseline(60 days)
- Assessment of the mean or median change in Tumor Necrosis Factor-alpha (TNF-alpha) relative to baseline(60 days)
- Assessment of the mean or median change in Fibrinogen Activity relative to baseline(60 days)
- Assessment of the mean or median change in Erythrocyte Sedimentation Rate (ESR) relative to baseline(60 days)
研究者
研究点 (2)
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