Effects of Short-term Interventions for a Healthy Lifestyle on the Human Lipidome in Subjects With Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- reduction of blood pressure
研究概览
简要总结
A growing number of cross-sectional studies is investigated the role of the human lipidome as a new biomarker for metabolic diseases. However, data on this issue is still sparse and especially interventional data is not available up to now.
"GesundLeben" will provide data on 100 human subjects with metabolic syndrome, undergoing distinct types of lifestyle intervention for 6 weeks. Standardized metabolic assessment will be covered with routine laboratory parameters and oral glucose tolerance test as well as non-radiologic anthropometric measurements.
详细描述
A growing number of cross-sectional studies is investigated the role of the human lipidome as a new biomarker for metabolic diseases. However, data on this issue is still sparse and especially interventional data is not available up to now. We intend to clarify, if the human lipidome is correlating with metabolic state and if changes in this state reflect on the lipidome. Using high-throughput shot-gun technique, we will be able to measure several hundreds of lipid species in one blood sample.
The "GesundLeben" trial will provide data on 100 human subjects with metabolic syndrome, undergoing distinct types of lifestyle intervention for 6 weeks. The cohort will be designed to include participants from both sexes, but be restricted on subjects without impaired glucose tolerance.
Standardized metabolic assessment will be covered with routine laboratory parameters (e.g. transaminases, HbA1c) and oral glucose tolerance test as well as non-radiologic anthropometric measurements (BMI, WHR, BIA).
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •hypertension
- •hyperuricemia
- •dyslipoproteinemia
排除标准
- •prediabetes / overt diabetes mellitus
- •present cancer
- •systemic infection
- •chronic inflammatory disease
- •recent stroke / myocardial infarction (6 months)
- •pregnancy
- •addiction / severe psychiatric diseases
研究组 & 干预措施
Physical activity only
pedometers have to be used throughout all days; daily amount of steps is reported via App or website; 10000 steps are defined as daily goal
干预措施: Lifestyle intervention (physical activity) (Behavioral)
Physical activity + Dietary treatment
pedometers have to be used throughout all days; daily amount of steps is reported via App or website; 10000 steps are defined as daily goal
additionally, subjects will be provided with one healthy muffin per day (450 kcal; low GI, high load of PUFA and isomaltulose) over 6 weeks
干预措施: Lifestyle intervention (PUFA/isomaltulose-enriched muffin) (Dietary Supplement)
Physical activity + Dietary treatment
pedometers have to be used throughout all days; daily amount of steps is reported via App or website; 10000 steps are defined as daily goal
additionally, subjects will be provided with one healthy muffin per day (450 kcal; low GI, high load of PUFA and isomaltulose) over 6 weeks
干预措施: Lifestyle intervention (physical activity) (Behavioral)
结局指标
主要结局
reduction of blood pressure
时间窗: 6 weeks
systolic and diastolic blood pressure
weight loss
时间窗: 6 weeks
loss in body weight / BMI
change in lipidome pattern
时间窗: 6 weeks
complex human lipidome (blood levels of several hundreds of lipid species) will be assessed before and after intervention
NAFLD reduction
时间窗: 6 weeks
NAFLD, estimated by fatty liver index (FLI)
次要结局
- improvement in quality of life(6 weeks)
- reduction of insulin resistance(6 weeks)
研究者
Prof. Dr. med. Andreas F. H. Pfeiffer
Director (Dpt. Clinical Nutrition)
German Institute of Human Nutrition