DRKS00030201招募中未知
Double-blind, randomised, placebo-controlled study to evaluate the effects of a synbiotic supplement on metabolic health - EV-RD/021021
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 21 Years 至 65 Years（—）
- 性别
- All
入选标准
- •1. Males and females
- •2. 21 to 65 year sold
- •3. BMI 23–34.9kg/m2
- •4. Generally in good health
- •5. LDL-C level =130mg/dL =189mg/dL (=3.359mmol/L = 4.854 mmol/L)
- •6. Stable body weight for at least 3 months prior to study inclusion (<5 % weight change) (self-reported)
- •7. Electrocardiogram (ECG) without pathological findings at V1
- •8. Having access to a smartphone/tablet or a computer with an internet access, and familiar with the use thereof (checked during the visit)
- •9. Readiness and ability to comply with study requirements, in particular:
- •- to take IP as recommended
- •- to accept the required blood draws
- •- to avoid the use of any nutritional, medical and further interventional options for management of blood lipids and/or blood sugar and/or body weight during the study (other than the IP)
- •- to keep the dietary and sleeping habits and the habitual level of physical activity during the study
- •- to complete the subject diary and questionnaires
- •10.Women of childbearing potential:
- •- commitment to use contraception methods
- •- negative pregnancy testing (beta human chorionic gonadotropin test in urine) at V1
- •11.Readiness not to participate in another clinical study during this study
排除标准
- •1.Known allergy or hypersensitivity to the components of the investigational product
- •2. Known genetic hyperlipidemia
- •3. History and/or presence of clinically significant known (self-reported) condition/disorder, which per investigator's judgement could interfere with the results of the study or the safety of the subject, e.g.:
- •- cardiovascular disease/disorder
- •- untreated or non-stabilised diabetes mellitus
- •- untreated or non-stabilised thyroid gland disorder
- •- untreated or non-stabilised hypertension (regular systolic blood pressure = 160 mmHg and/or dias- tolic blood pressure = 100 mmHg)
- •acute or chronic gastrointestinal (GI) disease or digestion/absorption disorders (e.g. inflammatory bowel disease, coeliac disease, pancreatitis etc.)
- •- immune deficiency or autoimmune disorder
- •- acute or chronic psychotic disorder
- •- eating disorder
- •- any other relevant serious diseases
- •4. Relevant surgical procedure with in the last 6 months prior to V1 or planned during the study (e.g. GI surgery, liposuction etc.), as per investigator's judgement
- •5. Clinically significant deviation of screening laboratory parameter(s) at V1
- •6. Regular medication and/or supplementation and/or treatment (including any natural health products) within the last month prior to V1 and during the study, as per investigator judgement:
- •- probiotics, prebiotics
- •- proton pump inhibitors
- •- lipid lowering products (known to affect lipid metabolism, platelet function, antioxidant status, etc.), in- cluding dietary or health supplements (e.g. omega- 3 fatty acids, oat fiber, plant sterols etc.)
- •- products that can influence cholesterol levels (e.g. corticosteroids, beta blockers, estrogen, anabolic steroids), unless long term and stabilised use (contraceptives are allowed in case of a stable continuous intake before and during the study)
- •- that could influence gastrointestinal functions (e.g. laxatives, opioids, anticholinergics etc.)
- •- that could influence body weight (e.g. fat binder/ burner, carb blocker, satiety products, neuroleptics etc.)
- •- that could influence glycemic control (e.g. metformin, acarbose etc.)
- •- any other, which could interfere with the results of the study or the safety of the subject
- •7. Antibiotics within the last month prior to V1 and during the study
- •8. Any electronic medical implant
- •9. Smoking >10cigarettes/day at time of V1 and during the study
- •10. Strict Mediterranean, strict vegan or fibre-rich diet
- •11. Women of childbearing potential: pregnancy or nursing
- •12. History of or current abuse of drugs, alcohol or medication
- •13. Participation in another study during the last 30 days prior to V1
- •14. Any other reason for exclusion as per investigator's judgment, e.g. insufficient compliance with study procedures
研究者
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