Evaluation of the Effects of a COcoa Supplement to Reduce FRailty in the Elderly: COFRE a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 主要终点
- Lipid oxidation
研究概览
简要总结
The study use a double blind, placebo-controlled design enrolling male and female subjects between 55-90 yo to evaluate the effect of daily consumption of a cocoa beverage on anthropometric, metabolic, oxidative stress, physical performance and quality of life.
详细描述
The study use a double blind, placebo-controlled design enrolling male and female subjects between 55-90 yo randomly assigned to consumption of a flavonoid rich mixture (flavonoids; F), alkalinized cocoa which eliminates flavonoid content (no flavonoids; NF) or placebo. All beverages had similar physical characteristics and flavor. Cocoa beverages were provided in individual sachets containing a dry powder that was reconstituted with water just before consumption. Subjects were instructed as above to maintain their usual lifestyle, to limit intake of high caloric foods and flavonoid-containing foods and beverages, and to walk for 30 min/day.
To determine the effect of flavonoids, study evaluates anthropometric measures, metabolic parameters as glycemia and a lipid profile (triglycerides, total cholesterol, high-density lipoprotein cholesterol and low-density lipoprotein cholesterol). To evaluate oxidative stress damage as lipid oxidation is measured with the malondialdehyde (MDA) assay. Protein carbonylation is measured using an assay for detection of carbonyl groups that relies on 2,4-dinitrophenylhydrazine (DNPH) as a substrate. The investigators also evaluate interleukin-6 and tumor necrosis factor levels.
For physical performance is evaluated the handgrip strength, and mobility assesment with the following test: Six-minute walk test, two-minute step, sit-up test and the up & go test.
The investigators also assessed quality of life using the Health Related QoL (EQ-5D) questionnaire.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 55 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sex: both
- •Age: 55-90 yo
- •Waist circumference: Women > 80 cm, Men > 90 cm
- •HDL-c: Women < 50 mg/dL, Men < 40 mg/dL
- •Triglycerides: ≥ 150 mg/dL
- •Glycemia: ≈100 mg/dL
- •Hand strength: Women< 20 kg, Men < 30 kg
- •Up & Go test: > 10 seconds
- •Non-inclusion criteria:
- •Any active infections
- •Malignancies
- •Habitual consumers of antioxidant supplements and cocoa products
- •Use of benzodiazepines or protein supplements
排除标准
- 未提供
研究组 & 干预措施
Placebo
Beverage without flavonoids
干预措施: Placebo (Other)
No Flavonoids
Beverage with alkalinized cocoa which eliminates flavonoid content
干预措施: No Flavonoids (Dietary Supplement)
Flavonoids
Beverage with a flavonoid rich mixture
干预措施: Flavonoids (Other)
结局指标
主要结局
Lipid oxidation
时间窗: At 90 days
Serum malondialdehyde Levels
Serum total cholesterol
时间窗: At 90 days
Fasting blood level
Protein oxidation
时间窗: At 90days
Serum protein carbonylation Levels
Serum LDL cholesterol
时间窗: At 90 days
Fasting blood level
Serum triacylglycerol concentration
时间窗: At 90 days
Fasting blood level
Serum HDL cholesterol
时间窗: At 90 days
Fasting blood level
Blood glucose
时间窗: At 90 days
Fasting blood level
次要结局
- Analog Visual Scale(At 60 days)
- Handgrip strength(At 60 days)
- Up and go test(At 60 days)
- Sit-up test(30 seconds)
- Six-minute walk test(6 minutes)
- EQ-5D questionnaire(At 60 days)
- Two-minute step in place test(2 minutes)
研究者
Guillermo Ceballos Reyes
Professor
National Polytechnic Institute, Mexico