Pilot Study to Evaluate the Effect of the Consumption of Two Unicellular Microalgae (Chlorella Vulgaris and Arthrospira Platensis (Spirulina)) on Metabolic Syndrome Biomarkers in Overweight / Obese Subjects With Altered Lipid Profile
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Serum cholesterol
研究概览
简要总结
The purpose of this study is to evaluate the effect of the consumption of two microalgae Chlorella vulgaris and Arthrospira platensis (Spirulina) on some biomarkers of metabolic syndrome: Total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, Apolipoprotein A and Apolipoprotein B, in overweight / obese subjects with altered lipid profile.
详细描述
A randomized, parallel, and double-blind pilot study with 3 study arms is being performed to evaluate the effect of the consumption of two unicellular microalgae: Chlorella vulgaris and Arthrospira platensis (Spirulina).
The investigators included 30 participants between 18 and 65 years (BMI ≥25 and <40 kg / m2). All volunteers will be randomized into 3 study groups, and participants will receive the 3 different study products during 30 days.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women from 18 to 65 years old.
- •Body Mass Index (BMI) ≥25 and <40 kg/m
- •Cardiovascular risk <10%
- •Adequate cultural level and understanding
- •Agree to participate in the study
排除标准
- •Subjects with BMI ≥40 or <25 kg /m2
- •Subjects diagnosed with Diabetes Mellitus.
- •Subjects with dyslipidemia on pharmacological treatment
- •Subjects with hypertension on pharmacological treatment
- •Subjects with established diagnosis of eating disorder
- •Smokers or those subjects with high alcohol consumption
- •Subjects under pharmacological treatment
- •Subjects with large weight fluctuations of more than 4 kg or who have undergone in six months a weight loss diet
- •Subjects with sensory problems
- •Subjects with gastrointestinal diseases that affect the digestion or absorption of nutrients
- •Pregnant or breastfeeding women
- •Women with menstrual irregularities
- •Subjects with intense physical activity
- •Subjects with food allergies to meals included in breakfast, study product or lunch or that reject their consumption
- •Subjects with a diagnosis of celiac disease or a gluten intolerance
研究组 & 干预措施
Group 1: Spirulina platensis
10 volunteers will consume 16g / day (in 2 doses of 8g) of a nutritional supplement of Spirulina platensis
干预措施: Experimental: Group 1: Spirulina platensis (Dietary Supplement)
Group 2: Chlorella vulgaris
10 volunteers will consume 16g / day (in 2 doses of 8g) of a nutritional supplement of Chlorella vulgaris
干预措施: Experimental: Group 2: Chlorella vulgaris (Dietary Supplement)
Group 3: Control
10 volunteers will consume 16g / day (in 2 doses of 8g) of a control supplement
干预措施: Placebo Comparator: Group 3: Control (Dietary Supplement)
结局指标
主要结局
Serum cholesterol
时间窗: Change from baseline at 30 days
Biomarker of metabolic syndrome
Serum HDL
时间窗: Change from baseline at 30 days
Biomarker of lipid profile quality
Serum LDL syndrome biomarker
时间窗: Change from baseline at 30 days
Biomarker of lipid profile quality
Apolipoprotein B
时间窗: Change from baseline at 30 days
Metabolic syndrome biomarker
Triglycerides (TAG)
时间窗: Change from baseline at 30 days
Biomarker of lipid profile quality
Apolipoprotein A
时间窗: Change from baseline at 30 days
Metabolic syndrome biomarker
次要结局
- Body weight(Change from baseline at 30 days)
- Calcium(Change from baseline at 30 days)
- Dietary intake(Change from baseline at 30 days)
- Blood count(Change from baseline at 30 days)
- Tolerance(Change from baseline at 30 days)
- Sensory perception Visual Analog Scale (VAS) rate from 1 to 100 related with flavor, aro(Change from baseline at 30 days)
- Glucose(Change from baseline at 30 days)
- Urate(Change from baseline at 30 days)
- Creatinine(Change from baseline at 30 days)
- Body Mass Index(Change from baseline at 30 days)
- Waist circumference(Change from baseline at 30 days)
- Adherence(Change from baseline at 30 days)