Acute Effects of Ultra-processed Versus Unprocessed Foods on Glucocorticoid Secretion in Healthy Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Blood cortisol change
研究概览
简要总结
The investigators aim to understand whether the acute cortisol response to food differs between differently processed foods.
In this monocentric, randomized, cross-over, open-label study, 20 healthy volunteers will receive two differently processed meals of similar caloric content and composition. The study will primarily focus on changes in blood cortisol levels, but other metabolic parameters will also be compared.
详细描述
Obesity is one of the most serious health problems of the 21st century, with ultra-processed diets being a major driver of the current obesity pandemic. Understanding how these diets affect body weight is critical to identifying new treatment targets. Current evidence suggests that the degree of food processing may affect cortisol secretion, a hormone that plays a key role in body weight regulation by increasing with acute food intake and promoting energy storage in adipose tissue. However, whether ultra-processed foods enhance cortisol response has not been thoroughly investigated.
Here, the investigators aim to understand the reaction of GCs in response to different processed foods in healthy volunteers. No medication will be used in this study.
Participants will be asked to refrain from strenuous physical activity and alcohol consumption for 24 hours prior to the study. They will fast for 12 hours before consuming a high-calorie, low-processed meal. After fasting again, participants will consume a high-calorie, ultra-processed meal on a second study day. The order of the meals is not fixed. The study will include a screening visit and two study visits.
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
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Males aged 18 to 40 years
- •BMI 18.5-29.9 kg/m2
排除标准
- •Severe acute or chronic disease
- •Lactose intolerance
- •Severe food allergy
- •Casual smoking (more than six cigarettes per day)
- •Frequent, heavy alcohol consumption (more than 30g/day)
- •Frequent, heavy caffeine consumption (more than 4 caffeinated drinks/day)
- •Regular physical exercise (more than 4hrs per week)
- •Shift work
- •Previous enrollment in a clinical trial within the past two months
- •Intake of any steroid-containing drugs, including topical steroids and inhalers, within four weeks of the study initiation
- •Contradictions to undergo the investigated intervention
- •Inability or unwillingness to provide informed consent
研究组 & 干预措施
Ultra-processed breakfast
During one study phase, subjects receive an ultra-processed breakfast
干预措施: Ultra-processed breakfast (Other)
Low-processed breakfast
During the other study phase, subjects receive a low-processed breakfast
干预措施: Low-processed breakfast (Other)
结局指标
主要结局
Blood cortisol change
时间窗: Up to six weeks
Change in blood cortisol assessed by repeadidly collecting blood before and after the meal
次要结局
- Energy expenditure (basal metabolic rate, diet-induced thermogenesis(Up to six weeks)
- Substrate utilization (respiratory quotient)(Up to six weeks)
- Body composition(Up to six weeks)
- Satiety(Up to six weeks)
- Weight(Up to six weeks)
- Motivation to eat(Up to six weeks)
- Systolic and diastolic blood pressure(Up to six weeks)
- Lipids (total cholesterol, LDL-cholesterol, HDL-cholesterol, and triglycerides)(Up to six weeks)
- Perceived stress(Up to six weeks)
- C-peptide(Up to six weeks)
- Insulin(Up to six weeks)
- Blood glucose(Up to six weeks)
- Neuroendocrine hormones (thyroid hormones, GLP1, glucagon, ACTH)(Up to six weeks)
研究者
Eleonora Seelig
Principal Investigator
University Hospital, Basel, Switzerland