A Pilot Study Investigating the Effects of the Combined Effects of Cocoa and Soy Polyphenols in a Soy Protein Matrix on Insulin Resistance and Cardiovascular Disease Risk in Type 2 Diabetes - A Randomised Placebo-Controlled Double-Blind Parallel Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Insulin resistance, lipid profile
研究概览
简要总结
Diabetes is an increasingly common condition affecting millions of people world wide. The cornerstone of treatment is lifestyle that includes looking at the way how people eat. It is known that food containing compounds called polyphenols can reduce the risk of heart disease risk in people with diabetes. Two foods that are rich sources of polyphenols are cocoa (epicatechins) and soy (isoflavones). Previous studies have shown the benefits of these foods in the diets of people with diabetes. It has also been shown that soy isoflavones and cocoa polyphenols can improve the mood in certain groups of patients.
What is not known is whether there is any extra benefit of combining soy protein and isoflavones with cocoa.
The aim of the study is to look at the modification of cardiovascular risk by soy and/or cocoa in patients with type 2 diabetes, alone or in combination.
详细描述
- General information about the study
The target number of participants is 100. All participants are patients with type 2 diabetes on diet alone or metformin treatment. Participants will be asked to eat two soy bars daily for 8 weeks. The length of the study is 10 weeks and involves 4 visits at the Diabetes Research Centre in Hull, UK.
The bars will contain:
- soy protein alone, or
- soy protein with additional isoflavones, or
- soy protein with cocoa, or
- soy protein with isoflavones and cocoa, or
- placebo bars without soy protein, isoflavones or cocoa.
The study is randomised (a computer based allocation schema will be used to decide which bars the participant will need to consume). Participants have the same 20% chance to be participant of any of the above groups. The study is placebo-controlled (there is one arm of placebo bars without soy protein, additional isoflavones or cocoa). The study is double-blind (neither the participants or the research team will know which bars they will take). 2. Study-specific procedures
Visit 1 (week 0). Non-fasting visit. Interested participants discuss the study with a member of the study team who will explain each aspect of the study, following which informed consent will be then obtained. Subsequently, blood pressure, weight, height and waist circumference will be measured, medical history and list of medication are recorded, and blood is taken to determine eligibility. A dietitian will explain about eating a normal diet and the foods we would like the participants to avoid during the study. Vegetarian patients may include too much soy in the diet and for this reason they will not be able to take part in the study. All participants will be non smokers.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with type 2 diabetes controlled by diet or metformin only
- •Stable medication history for 3 months prior to screening visit
- •Age 45-80
排除标准
- •Patients with concurrent illness or any medication (especially antibiotics)3 months prior to enrollment that would effect the study results based on investigator's judgement
- •Patients not wishing to allow disclosure to their GPs
- •Pre-menopausal women or on hormone replacement therapy
- •HbA1c >9% at screening
- •Patients with known food allergies
- •Vegans and vegetarians
研究组 & 干预措施
Soy protein alone with cocoa
Soy protein alone with cocoa with no isoflavones. 2 bars daily for 8 weeks.
干预措施: Cocoa (Dietary Supplement)
Soy protein alone with cocoa
Soy protein alone with cocoa with no isoflavones. 2 bars daily for 8 weeks.
干预措施: Soy protein (Dietary Supplement)
Soy protein with soy isoflavones
Soy protein with isoflavones bar. 2 bars daily for 8 weeks.
干预措施: Soy protein (Dietary Supplement)
Soy protein alone
Soy protein alone without soy isoflavone or cocoa polyphenol. 2 bars daily for 8 weeks.
干预措施: Soy protein (Dietary Supplement)
Soy protein with isoflavones and cocoa
Soy protein with isoflavones and cocoa bars. 2 bars daily for 8 weeks.
干预措施: Isoflavones (Dietary Supplement)
Soy protein with soy isoflavones
Soy protein with isoflavones bar. 2 bars daily for 8 weeks.
干预措施: Isoflavones (Dietary Supplement)
Placebo
Placebo bar without soy protein, isoflavones or cocoa polyphenols. 2 bars daily for 8 weeks
干预措施: Placebo (Dietary Supplement)
Soy protein with isoflavones and cocoa
Soy protein with isoflavones and cocoa bars. 2 bars daily for 8 weeks.
干预措施: Cocoa (Dietary Supplement)
Soy protein with isoflavones and cocoa
Soy protein with isoflavones and cocoa bars. 2 bars daily for 8 weeks.
干预措施: Soy protein (Dietary Supplement)
结局指标
主要结局
Insulin resistance, lipid profile
时间窗: 8 weeks
Soy with isoflavones and cocoa polyphenols have a greater impact on insulin resistance, lipid parameters in type 2 diabetes than seen with soy protein alone, soy protein with isoflavones and soy protein with cocoa polyphenols.
次要结局
- Endothelial function(8 weeks)
- Cardiovascular risk(8 weeks)
- Isoflavones(8 weeks)