Effect of Polyphenol-rich Dark Chocolate on Insulin Sensitivity in Normal Weight and Overweight Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Determine if the consumption of DC rich in polyphenols can induce a change in insulin sensitivity
研究概览
简要总结
The purpose of the study is to determine the effect of polyphenol-rich dark chocolate on insulin sensitivity in normal weight and overweight adults.
详细描述
Polyphenols may have several favourable effects on health. Dark chocolate (DC) is one of the highest sources of polyphenols in foods. The aim of the study is to determine the effect of polyphenol-rich dark chocolate on insulin sensitivity in normal weight and overweight adults. Seventy four volunteers with no history of hypertension, cardiovascular diseases or diabetes 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 four weeks. Participants will be asked to make two appointments to the university clinical lab. Anthropometric measurements (height, weight, waist circumference), blood and saliva samples will be taken during each of the 2 visits. Compliance will be tested by the measure of total polyphenols in a 24-hour urine sample in some random samples before 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 and a physical activity questionnaire will be collected before the start of the study and after four weeks. Data will be analysed with an ANCOVA with time (pre- and post-) and treatment (DC and placebo) as between-subject factor.
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
- 是
入选标准
- •Adults with no history of hypertension, diabetes and cardiovascular diseases
- •BMI from 18-24.9 and BMI >25
- •Males and Females
- •Age: 18-65 years
排除标准
- •Participants with cardiovascular diseases, hypertension or diabetes
- •Smokers and heavy alcohol drinkers
- •Participants taking any medications that affect insulin, cholesterol, triglycerides or blood pressure
- •Participants taking dietary supplements containing high doses of antioxidants
- •Postmenopausal women taking HRT (Hormone Replacement Therapy)
- •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
Determine if the consumption of DC rich in polyphenols can induce a change in insulin sensitivity
时间窗: Baseline and week 4
Insulin sensitivity will be determined by determined by HOMA-IR (Homeostasis Model of Assessment - Insulin Resistance)
次要结局
- Determine if the consumption of DC rich in polyphenols can induce a change in oxidized LDL levels(Baseline and week 4)
- Determine if the consumption of DC rich in polyphenols can induce a change in BMI and Waist circumference(Baseline and week 4)
- Determine if the consumption of DC rich in polyphenols can induce a change in blood pressure(Baseline and week 4)
- Determine if the consumption of DC rich in polyphenols can induce a change in glucose levels(Baseline and week 4)
- Determine if the consumption of DC rich in polyphenols can induce a change in Lipid profile (TC, HDL, LDL & TG)(Baseline and week 4)
- Determine if the consumption of DC rich in polyphenols can induce a change in salivary cortisol-to-cortisone ratio(Baseline and week 4)
- Determine if the consumption of DC rich in polyphenols can induce a change in high sensitivity CRP(Baseline and Week 4)
研究者
Grace Farhat
PhD research student
Queen Margaret University