Effect of a Black Garlic Extract With Greater Concentration of Bioactive Compounds and Lower Content in Undesired Compounds on Cholesterol LDL Levels. Chronic, Randomized, Crossover, Controled and Double Blind Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- LDL-c levels
研究概览
简要总结
One of the most characteristic components of the Mediterranean diet is garlic (Allium sativum L.), food to which has been attributed protective properties against cardiovascular diseases (CVD). Recently, several methods of garlic processing have been developed to obtain derivatives with milder organoleptic characteristics and a longer shelf life than habitual garlic derivates. One of these strategies is the aging of the garlic by high temperatures treatment that eliminates the taste and characteristic odor of garlic and gives it a dark color, a sweet taste and a slimy texture. Because the changes in the visual and organoleptic characteristics, the garlic obtained by aging at high temperatures is named black garlic.
Interestingly, these modifications translate into an increase in their antioxidant power and their protective capacity against the development of CVDs, mainly due to the formation of melanoidins and to the content of organosulfur derivatives of cysteine compounds, such as S-allyl-cysteine (SAC) and alliin.
Hypothesis of the study: The daily administration of a new extract of aged black garlic (SANE), with a higher concentration of bioactive compounds and lower unwanted compounds will lower cholesterol levels of low density lipoproteins (LDL-c), and will produce favorable changes on other markers of cardiovascular risk in individuals with moderate hypercholesterolemia.
Each 250 mg of SANE contains 0.5% in SAC, which will mean an amount of 1.25 mg of SAC per day, about 5 times more than SAC levels present in many of the black garlic products marketed.
The main objective was to evaluate the effect of the daily intake of a SANE with a higher concentration of bioactive compounds, SAC and alliin, and minor unwanted compounds such as simple sugars and furfural derivatives, in combination with dietary recommendations, on LDL-c levels in individuals with moderate hypercholesterolemia.
详细描述
Chronic, randomized, crossover, placebo-controlled and double-blind nutritional intervention trial.
The 60 participants in the study will be randomly divided into two groups of 30 participants, as they begin the study taking the SANE or placebo for 6 weeks.
At the end of study week 6, when the first treatment is finished, a 3-week washout period will be carried out, and then the treatment that will take place during another 6 weeks will be exchanged. Total study duration of 15 weeks.
The dose of SANE will be 250 mg daily, presented in a tablet of 550 mg / unit. The placebo will be microcrystalline cellulose. The consumption of SANE and placebo will be in the form of tablets with the same appearance, of 550 mg / tablet, guaranteeing that the study is blind both for the researchers of the project and for the participants (double blind).
The tablets will be presented in recipients of 45 units, so that with one recipient the participants will be able to carry out the entire intervention for each of the products.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The consumption of SANE and placebo will be in the form of tablets with the same appearance, of 550 mg / tablet, guaranteeing that the study is blind both for the researchers of the project and for the participants (double blind).
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women over 18 years of age.
- •Fasting serum LDL-c concentration ≥ 115 mg/dL.
- •Sign the informed consent.
排除标准
- •BMI ≥ 35 kg/m^2
- •LDL-c serum levels <115 mg/dL
- •Serum glucose levels higher than 126 mg/dL
- •Take supplements or multivitamin supplements or phytotherapeutic products that interfere with the treatment under study up to 30 days before the start of the study.
- •Be a smoker
- •Follow a hypocaloric diet and/or pharmacological treatment for weight loss.
- •Anti-hypertensive treatment.
- •Presenting anemia (hemoglobin ≤ 13 g/dL in men and ≤ 12 g/dL in women).
- •Present some chronic gastrointestinal disease.
- •Present some chronic disease in clinical manifestation.
- •Being pregnant or intending to become pregnant.
- •Be in breastfeeding period.
- •Participate in or have participated in a clinical trial or nutritional intervention study in the last 30 days prior to inclusion in the study.
- •Being unable to follow the study guidelines.
结局指标
主要结局
LDL-c levels
时间窗: At week 1, week 3 and week 6 for each of the two treatments (SANE and placebo).
Serum LDL-c levels will be measured by standardized methods in Cobas Mira Plus autoanalyzer (Roche Diagnostics Systems, Madrid, Spain).
次要结局
- Measures of body weight(At week 1, week 3 and week 6 for each of the two treatments (SANE and placebo).)
- Measures of height(At week 1, week 3 and week 6 for each of the two treatments (SANE and placebo).)
- Measures of BMI(At week 1 for each of the two treatments (SANE and placebo).)
- Measures of waist circumference(At week 1, week 3 and week 6 for each of the two treatments (SANE and placebo).)
- Bood pressure (measured in mmHg)(At week 1, week 3 and week 6 for each of the two treatments (SANE and placebo).)
- Lipid metabolism(At week 1, week 3 and week 6 for each of the two treatments (SANE and placebo).)
- Glucose metabolism(At week 1, week 3 and week 6 for each of the two treatments (SANE and placebo).)
- Inflammation(At week 1, week 3 and week 6 for each of the two treatments (SANE and placebo).)