Acute Metabolic Challenge for the Assessment of Cardiometabolic Protective Effects of Foods
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Area under the curve (AUC) of postprandial triglyceridemia (0-4h) after each intervention, compared to the reference meal
研究概览
简要总结
After an energy-rich meal the blood levels of glucose and lipids undergo a marked temporary increase, triggering a wave of oxidative stress due to the appearance of excess free radicals in adipose and muscle tissues. Elevated postprandial hypertriglyceridemia has been associated with increased risk of cardiovascular disease and type 2 diabetes. Hence, postprandial changes in different circulating biomarkers are potential predictors of cardiometabolic risk. In addition to the possibility of evaluating acute variations in metabolic risk markers in response to different types of fat, the metabolic challenge approach may serve as a challenge-meal background in order to reveal possible beneficial effects of specific food ingredients. In this study, circulating cardiometabolic disease-related biomarkers, including endotoxemia, will be assessed postprandially in search for beneficial actions of particular functional food ingredients consumed in combination with a high-fat meal.
详细描述
The study will be carried out in a group of healthy mature subjects with overweight and normal fasting blood glucose values.
A randomized crossover design will be followed, in which the postprandial metabolic responses to a high fat breakfast (HF) will be compared with those registered after an identical breakfast containing a functional ("active") ingredient. Each meal will be tested in an independent experimental session. Experimental sessions will take place with1 week interval. The study will be carried out at the Food for Health Laboratory, Food for Health Science Centre - Lund University (Medicon Village, Lund).
The volunteers will consume the challenge HF alone and with 4 active ingredients, i.e. each volunteer will undergo five experimental sessions. Additionally, the plan contemplates an initial information visit that includes the screening of fasting blood glucose. In total, each volunteer completing the study will pay six visits to the Food for Health Laboratory.
Based on the results from the above-described phase, a second step of the study will focus on the impact of the order of consumption -i.e. "active ingredient" before HF and vice versa on cardiometabolic risk outcomes, as a way to optimize putative protective actions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 73 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •overweight (BMI between 25 and 30)
- •fasting blood glucose value ≤ 6.1 mmol/l.
排除标准
- •treatment for dyslipidemia
- •treatment for hypertension
研究组 & 干预措施
High fat meal
Subjects eat a high fat breakfast (reference breakfast) at 7:30 am. The meal contains 50 g fat and 900 kcal. Blood samples are taken before the breakfast and every 30 min postprandial for 4 h.
干预措施: Reference breakfast (Other)
High fat meal + Active Ingredient 1
Subjects eat the same high fat breakfast with the "active ingredient 1" at 7:30 am. The meal contains 50 g fat and 900 kcal. Blood samples are taken before the breakfast and every 30 min postprandial for 4 h.
干预措施: Active Ingredient 1 (Other)
High fat meal + Active Ingredient 2
Subjects eat the same high fat breakfast with the "active ingredient 2" at 7:30 am. The meal contains 50 g fat and 900 kcal. Blood samples are taken before the breakfast and every 30 min postprandial for 4 h.
干预措施: Active Ingredient 2 (Other)
High fat meal + Active Ingredient 3
Subjects eat the same high fat breakfast with the "active ingredient 3" at 7:30 am. The meal contains 50 g fat and 900 kcal. Blood samples are taken before the breakfast and every 30 min postprandial for 4 h.
干预措施: Active Ingredient 3 (Other)
High fat meal + Active Ingredient 4
Subjects eat the same high fat breakfast with the "active ingredient 4" at 7:30 am. The meal contains 50 g fat and 900 kcal. Blood samples are taken before the breakfast and every 30 min postprandial for 4 h.
干预措施: Active Ingredient 4 (Other)
结局指标
主要结局
Area under the curve (AUC) of postprandial triglyceridemia (0-4h) after each intervention, compared to the reference meal
时间窗: 4 hours postprandial
plasma triglycerides are measured pre-meal and at various post-meal intervals for up to for 4 hours. The area under curve (AUC) is calculated and compared to AUC following the reference meal.
次要结局
- Area under the curve of postprandial glycemia (0-4h) after each intervention, compared to the reference meal(4 hours postprandial)
- AUC of postprandial endotoxemia, i.e. lipopolysaccharide (LPS) concentrations (0-4h) after each intervention, compared to the reference meal(4 h postprandial)
研究者
Juscelino Tovar
Project Leader
Lund University