Impact of Orange Juice During Breakfast on Glycaemic Control in Individuals With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Insulin responses
研究概览
简要总结
The evidence on the consumption of 100% orange juice in people with type 2 diabetes is highly variable and largely out-of-date, with a few studies reporting acute negative glycaemic effects when 100% orange juice is drunk with or without a meal. The aim of the project is to study the impact of the intake of a single serving of 100% orange juice on glycaemic control in male patients with pre-existing type 2 diabetes mellitus. In addition, immunological parameters and Alzheimer disease related biomarkers will be assessed to examine the chronic inflammatory state of these patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria: individuals (aged 25-75 years) with up to 8 years of T2DM, according to ADA criteria (Two-hour plasma glucose ≥200 mg/dL (11.1 mmol/L) during OGTT. The test should be performed as described by the WHO, using a glucose load containing the equivalent of 75-g anhydrous glucose dissolved in water; or HbA1c > ≥6.5% (48 mmol/mol)).
排除标准
- •pregnancy,
- •participants on exogenous insulin therapy,
- •HbA1c >8.5%,
- •BMI <22 or >35 kg/m²,
- •regular smokers (>1 cigarette per day),
- •participants with established cardiovascular disease,
- •neurological disease,
- •renal disease.
- •Participants who are unwilling to consume any of the standard foods/drinks
结局指标
主要结局
Insulin responses
时间窗: Day 10
Venous blood samples collected to examine systemic insulinemia (venous blood insulin concentration (pmol/L)) before, during and after a breakfast (differing in supplemented juice composition) for up to 5 hours postprandial.
Glycaemic responses venous blood
时间窗: Day 10
Venous blood samples collected to examine systemic glycemia (venous blood glucose concentration (mg/dL)) before, during and after a breakfast (differing in supplemented juice composition) for up to 5 hours postprandial.
Capillary glycaemic responses
时间窗: Day 10
Capillary blood samples collected to examine glycemia before, during and after a breakfast (differing in supplemented juice composition) for up to 5 hours postprandial.
次要结局
- Flow cytometry(Baseline)
- Systolic/diastolic blood pressure(Baseline)
- Glycated haemoglobin measure(Baseline)
- BMI(Baseline)
- Alzheimer disease related biomarkers(Baseline)
- Waist/hip circumference (Body composition)(Baseline)
研究者
Dominique Hansen
Principal Investigator
Hasselt University