The Effects of CGA-rich Coffee on Cognitive Function in Type 2 Diabetes: A Parallel Groups Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Verbal memory
研究概览
简要总结
Coffee has been found to have beneficial effects on cognitive function and blood sugar control. Benefits include reduced risk of cognitive decline and improved performance on cognitive tests, as well as reduced risk of diabetes and improved blood sugar control in people with diabetes, a population that is at a higher risk of cognitive decline. These effects have been observed for both caffeinated and decaffeinated coffee, and have been associated with the polyphenol chlorogenic acid (CGA). This polyphenol has been found to be more bioavailable in certain coffees, known as "speciality coffee" as defined by the Specialty Coffee Association of America, depending on agriculture, roasting, and brewing method.
This current project will bring together these previous findings to explore the effects of specialty coffee on cognitive function and glycaemic control in people with type 2 diabetes through a randomized control trial with two groups: a high CGA specialty coffee group and a conventional coffee control group. Participants will be quasi-randomly assigned to one of these two groups following the completion of a 4-week run-in period during which participants will consume conventional coffee only. The length of the experimental arms is 8 weeks, therefore the total length of the study is 12 weeks. At the beginning and the end of each experimental arm participants will undertake a cognitive assessment online using the Gorilla platform, and a series of questionnaires relating to health and mood measures (details in procedure). Cognitive function will also be assessed at the beginning of the 4-week run-in period.
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
- 55 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 55-70 years
- •Formal diagnosis of Type 2 Diabetes for 3 years or more
- •Current coffee drinkers, 4 or fewer cups daily (a cup is 8 oz)
排除标准
- •Insulin-dependent
- •Consuming on average more than 4 cups of coffee daily
- •Regularly consuming specialty coffee (participants will be provided with a list of these coffees)
研究组 & 干预措施
CGA-rich coffee (Speciality coffee)
Participants will be provided with a single origin, CGA-rich specialty coffee as graded by the Specialty Coffee Association of America's Q-grading system to brew and consume
干预措施: Coffee (Other)
Conventional coffee
Participants will be provided with a conventional, low CGA coffee to brew and consume which contains less CGA than the experimental arm.
干预措施: Coffee (Other)
结局指标
主要结局
Verbal memory
时间窗: -4 weeks
Assessed at the beginning of the 4-week run-in period using a modified version of the Rey Auditory Verbal Learning Test
Verbal memory
时间窗: 8 weeks
Assessed at the end of 8-week intervention arm using a modified version of the Rey Auditory Verbal Learning Test
Verbal memory
时间窗: 0 weeks
Assessed at the beginning of the 8-week intervention arm using a modified version of the Rey Auditory Verbal Learning Test
次要结局
- Working memory(-4 weeks)
- Depression symptoms(-4 weeks)
- Executive Function(-4 weeks)
- Lipid panel (total cholesterol, HDL, LDL, triglycerides)(-4 weeks)
- Anxiety symptoms(-4 weeks)
- Processing Speed(-4 weeks)
- Haemoglobin A1C(-4 weeks)
- Haemoglobin A1C(8 weeks)
- Haemoglobin A1C(0 weeks)
- Lipid panel (total cholesterol, HDL, LDL, triglycerides)(8 weeks)
- Lipid panel (total cholesterol, HDL, LDL, triglycerides)(0 weeks)
- Depression symptoms(8 weeks)
- Depression symptoms(0 weeks)
- Anxiety symptoms(8 weeks)
- Anxiety symptoms(0 weeks)
- Executive Function(8 weeks)
- Executive Function(0 weeks)
- Working memory(0 weeks)
- Processing Speed(8 weeks)
- Processing Speed(0 weeks)
研究者
Daniel Lamport
Associate Professor Daniel Lamport
University of Reading