Impact of Healthy Diet on Metabolic Health in Men and Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in blood glucose
研究概览
简要总结
The overall aim of the present research program is to determine how a healthy whole-diet approach impacts on cardiometabolic health in adults. With its interdisciplinary approach, the study depicts mechanisms behind disease progression and the impact of healthy dietary patterns on changes in markers of low-grade systemic inflammation together with the exploration of knowledge and attitudes about healthy diets. The study has a preventive character as it targets older adults (65+) without manifest disease.
详细描述
This two arm randomized-controlled study includes the following groups: Controls and Healthy Diet group.
The study will particularly address the following aspects:
- determine food literacy, perceived attitudes and barriers for the adoption of new dietary habits incorporating increased fruit and vegetable intake in adults.
- explore the effects of a randomized controlled intervention promoting healthy dietary patterns (increased intakes of fruit and vegetable, whole-grain, nuts and low fat dairy products and replacing saturated with unsaturated fats and decreased red meat and salt consumption) for a period of 4 months on components of the metabolic syndrome, a large panel of pro- and anti-inflammatory biomarkers and metabolomic profile in adults.
- assess the long-term adherence to healthy dietary patterns in adults.
- provide support for behavioural change and evaluate participants' perception of this support.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 70 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •65-70 years
- •not meeting 5 servings of fruit and vegetable per day
- •Waist circumference >80 cm (female) and >88 (male)
排除标准
- •Movement disability
- •Diabetes, cardiovascular disease, lung disease, overt disease
研究组 & 干预措施
Controls
No changes in dietary habits
Healthy Diet
Changes in dietary habits only
干预措施: Healthy Diet (Behavioral)
结局指标
主要结局
Change in blood glucose
时间窗: Before and after 16 weeks
Blood glucose (mmol/L) assessed using chemistry kits from Ortho-Clinical Diagnostics on a Vitros-5.1 analyzer platform (Clinical Diagnostics, Raritan, NJ, United States)
Change in plasma triglycerides
时间窗: Before and after 16 weeks
Plasma triglycerides (mmol/L) : assessed using chemistry kits from Ortho-Clinical Diagnostics on a Vitros-5.1 analyzer platform (Clinical Diagnostics, Raritan, NJ, United States)
Change in high-density lipoprotein cholesterol
时间窗: Before and after 16 weeks
high-density lipoprotein cholesterol (mmol/L) : assessed using chemistry kits from Ortho-Clinical Diagnostics on a Vitros-5.1 analyzer platform (Clinical Diagnostics, Raritan, NJ, United States)
Change in waist circumference
时间窗: Before and after 16 weeks
waist circumference (cm) assessed by a steel tape
Change in diastolic and systolic blood pressure (mmHg)
时间窗: Before and after 16 weeks
diastolic and systolic blood pressure (mmHg) assessed using a manual sphygmomanometer
Change in intake of fruit and vegetable
时间窗: Before and after 16 weeks
- Fruit and vegetable intake assessed on a 7 scale-item where the lowest value of 1, indicates an intake less than 1 per month, and 7 an intake of at least 5 servings /day.
次要结局
未报告次要终点
研究者
Fawzi Kadi
Professor
Örebro University, Sweden