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临床试验/NCT01749852
NCT01749852已完成不适用

Effect of Polyphenol-rich Dark Chocolate on Body Weight in Overweight and Obese Adults: A Pilot Study

Queen Margaret University2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
2
主要终点
Change in Body weight

研究概览

简要总结

The aim of this study is to investigate if dark chocolate rich in polyphenols decreases body weight/ body fat in the overweight and obese adult population.

详细描述

Polyphenols are phytochemicals widely available in plants, and may have several favourable effects on health. Dark chocolate (DC) is one of the highest sources of polyphenols in foods. Animal and in vitro studies have demonstrated that cocoa and dark chocolate may exert anti-obesity effects mainly due to the polyphenol effect on glucose and fatty acid metabolism. Human studies have showed that regular chocolate eaters have a lower body weight compared to non regular eaters, and that DC promotes satiety and reduces cravings. The aim of this pilot study is to investigate the effect of polyphenol-rich DC on body weight in the overweight and obese adult population, when incorporated into a non-restricted diet. Twenty-eight apparently healthy volunteers will be recruited. Participants will randomly receive 20g daily of one of the two different types of DC: Placebo DC (low in polyphenols) or DC rich in polyphenols (500mg) for a period of twelve weeks. Participants will be asked to make three appointments and one follow-up appointment to the university clinical lab. Anthropometric measurements (height, weight, waist circumference, body fat percentage) will be taken during each visit. Compliance will be defined by the intake of 85 % or more of the chocolate weekly, and will be tested by the measure of total polyphenols in a 24-hour urine sample before, during and at the end of the intervention. To monitor any fluctuations in the participants' diet or physical activity during the study period, a three-day diet diary, a Food Frequency questionnaire assessment for polyphenol intake and a physical activity questionnaire will be collected before the start of the study and every four weeks. A follow-up appointment (four weeks after the end of intervention) will check if any differences in anthropometric measures have been maintained. Data will be analysed with an ANCOVA with time (pre- and post-) and treatment (DC and placebo) as between-subject factor. This study will have novel findings and will be the basis for a future larger trial.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

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

入选标准

  • Healthy adults
  • BMI between 25-35
  • Males and Females
  • Age: 18-65 years

排除标准

  • Participants with cardiovascular diseases, hypertension or diabetes
  • Participants taking any medications that affect insulin, cholesterol, triglycerides or Blood pressure
  • Participants who recently participated or are currently on a weight management program
  • Participants with regular consumption of cocoa or DC (> 1 serving/week)

结局指标

主要结局

Change in Body weight

时间窗: Baseline, week 6, week 12 and week 16

The body weight will be measured using a digital scale

次要结局

  • Change in Body Fat percentage(Baseline, week 6, week 12 and week 16)
  • Change in Waist circumference(Baseline, week 6, week 12 and week 16)
  • Change in urinary Cortisol-to-cortisone ratio(Baseline, week 6 and week 12)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Grace Farhat

PhD research student

Queen Margaret University

研究点 (2)

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