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临床试验/NCT05290012
NCT05290012已完成不适用

The Effect of Dark Chocolate Consumption on Blood Parameters in Healthy Adult Individuals

Eastern Mediterranean University1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2020年12月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
37
试验地点
1
主要终点
Change in serum lipid levels from baseline with dark chocolate consumption at 4 weeks.

研究概览

简要总结

In healthy individuals, the effect of regular dark chocolate consumption for 4 weeks on blood lipid parameters such as; total cholesterol, LDL cholesterol, HDL cholesterol and triglyceride levels, in addition to fasting blood glucose, HbA1c, CRP levels and blood pressure was investigated.

详细描述

Recent studies have shown that dark chocolate consumption may have a positive effect on cardiovascular risk markers.The aim of this study is to investigate the effect of regular consumption of dark chocolate (36 g/day) on biochemical blood parameters in healthy individuals. A total of 37 healthy individuals completed the study conducted in this direction. Participants were randomly divided into two groups as dark chocolate group (n=17) and control group (n=20). While the dark chocolate group consumed 36 g/day (400 mg/day flavanol) dark chocolate for 4 weeks, the control group did not receive any intervention. At the end of the study, the anthropometric measurements of the individuals were evaluated. Blood lipid profile, fasting blood glucose, HbA1c, CRP levels, systolic blood pressure and diastolic blood pressure measurements were investigated.

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
None

入排标准

年龄范围
19 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • BMI < 30 kg/m2
  • Systolic blood pressure <140 mmHg and/or diastolic blood pressure <90 mmHg

排除标准

  • Individuals with any diagnosed chronic or acute illness
  • Individuals diagnosed or in contact with Covid-19
  • Individuals with allergies to cocoa/chocolate products
  • Individuals in the process of losing weight
  • Individuals with smoking and alcohol consumption
  • Individuals taking medication or vitamin/mineral supplements
  • Individuals doing heavy physical activity
  • Individuals who regularly consume cocoa/chocolate products for the last 1 month (> 3 days a week)
  • Pregnant or lactating women were excluded from the study.

结局指标

主要结局

Change in serum lipid levels from baseline with dark chocolate consumption at 4 weeks.

时间窗: Baseline and Week 4

Serum lipid levels (total cholesterol, LDL cholesterol, HDL cholesterol and triglyceride) were measured by taking blood samples from individuals at the beginning and end of the study. Differences in blood lipid variables were analyzed using the Statistical Package for Social Sciences (SPSS) 24.0 program. Change = (Baseline serum lipid levels-Week 4 serum lipid levels)

Change in glycemic parameters from baseline with dark chocolate consumption at 4 weeks.

时间窗: Baseline and Week 4

At the beginning and end of the study, blood samples were taken from the individuals and their HbA1c and fasting blood glucose levels were measured. Differences in glycemic variables were analyzed using the Statistical Package for Social Sciences (SPSS) 24.0 program. Change = (Baseline glycemic parameters-Week 4 glycemic parameters)

Change in CRP levels from baseline with dark chocolate consumption at 4 weeks.

时间窗: Baseline and Week 4

At the beginning and end of the study, blood samples were taken from the individuals and their CRP (C-reactive protein) levels were measured. Differences in the CRP variable were analyzed using the Statistical Package for Social Sciences (SPSS) 24.0 program. Change = (Baseline CRP levels-Week 4 CRP levels)

Change in blood pressure from baseline with dark chocolate consumption at week 4.

时间窗: Baseline and Week 4

At the beginning and end of the study, the blood pressure (systolic blood pressure and diastolic blood pressure) measurements of the individuals were measured with the Nimo LD-520 digital blood pressure device. Change = (Baseline blood pressure-Week 4 blood pressure)

次要结局

  • Change in body weight from baseline with dark chocolate consumption at week 4.(Baseline and Week 4)
  • Change in BMI from baseline with dark chocolate consumption at week 4.(Baseline and Week 4)
  • Change in body fat percentage from baseline with dark chocolate consumption at week 4.(Baseline and Week 4)
  • Change in waist circumference from baseline with dark chocolate consumption at week 4.(Baseline and Week 4)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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