Algae Effects in Markers of Cardiovascular Risk and Gut Microbiome: a Placebo-controlled Randomized Double-blind Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Plasma trimethylamine-N-oxide levels
研究概览
简要总结
The Western diet, rich in fat and sugar, contributes to cardiovascular risk and alters the body metabolism, specifically through the modulation of the microbiome. Microbiome is considered the "second genome", functioning as an endocrine-like organ. Gut microbiota-derived metabolites, namely trimethylamine- N-oxide and short-chain fatty acids have been associated with atherosclerosis, vascular and cardiac diseases. Regarding trimethylamine- N-oxide, its association with cardiovascular disease is positive and dose-dependent. In contrast, short-chain fatty acids have been positively associated with the improvement of cardiovascular health.
Algae probiotics can modulate gut microbiome, stimulating the growth of commensal micro-organisms with health benefits. Previous studies suggested that Spirulina Arthrospira platensis supplementation could improve blood lipid levels and lower blood pressure, revealing anti-inflammatory and antioxidant roles. Other probiotics that could be beneficial to gut microbiota are macroalgae or seaweed. Macroalgae are a rich source of components which may prompt bacterial diversity and abundance.
The present prospective, randomized, three-armed parallel trial aims to generate good-quality evidence about the potential health effects and impact of Spirulina Arthrospira platensis (microalgae) and Gelidium corneum (macroalgae) supplements in humans. These participants will undergo 3 clinical evaluations: 2 before the beginning of micro- and macro-algae supplementation and the last one after 20 weeks of supplementation. The evaluation includes a vascular, nutritional and physical activity assessment, as well as blood, urine, saliva and stool collection for quantification of plasma biomarkers, oral and gut microbiota analysis, respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
double-blind masking
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥50 years
- •BMI ≥20 kg/m2
- •History of stroke, coronary artery disease, myocardial infarction, peripheral artery disease, chronic kidney disease (eGFR <75 ml/min at least for 3 months), albuminuria >300 mg/g, or diabetes mellitus
- •No antibiotics in the previous 30 days
- •If a woman, she must be a woman of non-childbearing potential. That is, she must be:
- •Surgically sterilized (e.g. underwent hysterectomy, bilateral salpingectomy or bilateral oophorectomy);
- •Clinically diagnosed infertile;
- •In a post-menopausal state, defined as no menses for 12 months without an alternative medical cause.
- •A woman patient of childbearing potential must have a negative serum pregnancy test at Visit 0 (Day 0) and must agree to use consistently and correctly (from 28 days prior to first study treatment administration until at least 7 days after last study treatment administration) one of the following highly effective methods of contraception:
- •Abstinence of heterosexual intercourse (when this is in line with preferred and usual lifestyle of the subject);
- •Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable);
- •Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal);
- •Intrauterine device;
- •Intrauterine hormone-releasing system;
- •Bilateral tubal occlusion;
- •Vasectomized partner, who has received medical assessment of the surgical success, or clinically diagnosed infertile partner.
排除标准
- •Unwilling to sign the informed consent form (if the patient wants to participate but cannot sign for any reason, then a third-person testimony may sign/complete the informed consent form on the patient's behalf).
- •Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site).
- •Participation in another clinical study with an investigational product during the last month.
- •In participants recruited at Unidade Local de Saúde de São João, the exclusion criteria applied is estimated Glomerular Filtration Rate (eGFR) <30 ml/min/1.73m2 estimated with the CKD-EPI (2021) formula or dialysis. For participants recruited at community, this exclusion criteria is adapted for diagnosis of end-stage renal disease or dialysis (no need to quantify the eGFR).
研究组 & 干预措施
Placebo
during 20 weeks
干预措施: Placebo (Other)
Spirulina Arthrospira platensis
during 20 weeks
干预措施: Spirulina Arthrospira platensis (microalgae) (Dietary Supplement)
Gelidium corneum
during 20 weeks
干预措施: Gelidium corneum (Dietary Supplement)
结局指标
主要结局
Plasma trimethylamine-N-oxide levels
时间窗: Visit 1 (day 7 to day 30) and Visit 2 (20 weeks ± 15 days from Visit 1)
To assess the effect of the Spirulina Arthrospira platensis versus Gelidium corneum versus placebo on the between-group ratio of geometric means difference of the Log transformed plasma trimethylamine- N-oxide levels change from baseline to 20 weeks. The co-primary comparison will be Spirulina Arthrospira platensis versus Placebo and Gelidium corneum versus Placebo with a 2.5% alfa for each comparison.
次要结局
- Lipoprotein A(Visit 1 (day 7 to day 30) and Visit 2 (20 weeks ± 15 days from Visit 1))
- Plasma short-chain fatty acids levels(Visit 1 (day 7 to day 30) and Visit 2 (20 weeks ± 15 days from Visit 1))
- Gut microbiota(Visit 1 (day 7 to day 30) and Visit 2 (20 weeks ± 15 days from Visit 1))
- Systolic blood pressure(Visit 1 (day 7 to day 30) and Visit 2 (20 weeks ± 15 days from Visit 1))
- Diastolic blood pressure(Visit 1 (day 7 to day 30) and Visit 2 (20 weeks ± 15 days from Visit 1))
- Body weight(Visit 1 (day 7 to day 30) and Visit 2 (20 weeks ± 15 days from Visit 1))
- Total cholesterol(Visit 1 (day 7 to day 30) and Visit 2 (20 weeks ± 15 days from Visit 1))
- Low-density lipoprotein cholesterol(Visit 1 (day 7 to day 30) and Visit 2 (20 weeks ± 15 days from Visit 1))
- High-density lipoprotein cholesterol(Visit 1 (day 7 to day 30) and Visit 2 (20 weeks ± 15 days from Visit 1))
- Interleukin-6(Visit 1 (day 7 to day 30) and Visit 2 (20 weeks ± 15 days from Visit 1))
- Glucose(Visit 1 (day 7 to day 30) and Visit 2 (20 weeks ± 15 days from Visit 1))
- Insulin(Visit 1 (day 7 to day 30) and Visit 2 (20 weeks ± 15 days from Visit 1))
- Haemoglobin A1c(Visit 1 (day 7 to day 30) and Visit 2 (20 weeks ± 15 days from Visit 1))
- Estimated Glomerular Filtration Rate(Visit 1 (day 7 to day 30) and Visit 2 (20 weeks ± 15 days from Visit 1))
- High-sensitivity C-reactive protein(Visit 1 (day 7 to day 30) and Visit 2 (20 weeks ± 15 days from Visit 1))
- Cerebral blood flow velocities(Visit 1 (day 7 to day 30) and Visit 2 (20 weeks ± 15 days from Visit 1))
- Neurovascular coupling (visual stimulation)(Visit 1 (day 7 to day 30) and Visit 2 (20 weeks ± 15 days from Visit 1))
- Triglycerides(Visit 1 (day 7 to day 30) and Visit 2 (20 weeks ± 15 days from Visit 1))
- Potassium(Visit 1 (day 7 to day 30) and Visit 2 (20 weeks ± 15 days from Visit 1))
- Sodium(Visit 1 (day 7 to day 30) and Visit 2 (20 weeks ± 15 days from Visit 1))
- Oral microbiota(Visit 1 (day 7 to day 30) and Visit 2 (20 weeks ± 15 days from Visit 1))
- Pulse wave velocity(Visit 1 (day 7 to day 30) and Visit 2 (20 weeks ± 15 days from Visit 1))
- Intima-media thickness(Visit 1 (day 7 to day 30) and Visit 2 (20 weeks ± 15 days from Visit 1))
- Cerebral blood flow resistance indexes(Visit 1 (day 7 to day 30) and Visit 2 (20 weeks ± 15 days from Visit 1))
- Cerebral vascular reactivity(Visit 1 (day 7 to day 30) and Visit 2 (20 weeks ± 15 days from Visit 1))
- Breath-holding index(Visit 1 (day 7 to day 30) and Visit 2 (20 weeks ± 15 days from Visit 1))
- Mediterranean diet adherence screener score(Visit 1 (day 7 to day 30) and Visit 2 (20 weeks ± 15 days from Visit 1))
- Total score of physical activity(Visit 1 (day 7 to day 30) and Visit 2 (20 weeks ± 15 days from Visit 1))