THERMOS-LUNCH: Effects of Meals Differing in Nutritional Quality and Environmental Footprint on Postprandial Metabolism, Diet-Induced Thermogenesis, Respiratory Quotient, Satiety, and Hydration Status in Healthy Young Men
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Diet-Induced Thermogenesis
研究概览
简要总结
This randomized crossover study evaluated the acute postprandial metabolic and hydration responses to two standardized lunch meals differing in nutritional quality and environmental footprint in healthy young men. Each participant consumed both meals in separate experimental visits according to a randomized sequence. Postprandial oxygen consumption, carbon dioxide production, respiratory quotient, energy expenditure, diet-induced thermogenesis, substrate oxidation, satiety, and hydration-related outcomes were assessed.
详细描述
The THERMOS-LUNCH study (Thermogenesis, Hydration, Environmental Impact, Respiratory Quotient, Meals, Substrate Oxidation and Sustainability after Lunch in University Students: a Nutritional Crossover Study in Healthy Subjects) was a randomised, two-period, two-sequence crossover intervention study conducted in healthy male university students. The study compared two standardised lunch meals that differed in nutritional quality and estimated environmental impact: a healthy and sustainable meal and a less healthy and non-sustainable comparison meal. Participants were randomly assigned to one of two intervention sequences: the healthy and sustainable meal followed by the comparison meal, or the comparison meal followed by the healthy and sustainable meal. The two experimental visits were separated by a 7-day washout period.
During each experimental visit, postprandial metabolic responses were assessed using portable indirect calorimetry. Oxygen consumption, carbon dioxide production, respiratory exchange ratio, energy expenditure, diet-induced thermogenesis and substrate oxidation were measured during the fasting baseline period and over the 4-hour postprandial period. Subjective appetite and satiety sensations were assessed repeatedly using 100-millimetre visual analogue scales. Hydration-related measures included total fluid intake, urine volume, urine colour and urine specific gravity measured using a digital refractometer. Total urinary nitrogen, obtained from the 24-hour urine collection, was used to account for protein metabolism in substrate-oxidation calculations, while urinary creatinine was used as a quality-control marker for the plausibility and completeness of the 24-hour urine collection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male participants aged 18 to 30 years.
- •Students enrolled at the University of Parma.
- •Residence or domicile in areas surrounding the University of Parma campus.
- •Stable body weight during the previous 6 months, defined as body weight change within ±5%.
- •Good general health.
- •Willingness to comply with study procedures.
- •Written informed consent provided before participation.
排除标准
- •Female sex.
- •Age younger than 18 years or older than 30 years.
- •Food allergies or food intolerances incompatible with the test meals.
- •Chronic noncommunicable food-related diseases, including metabolic, endocrine, or chronic disorders.
- •Residence or domicile outside areas adjacent to the University of Parma campus.
- •Students enrolled at the University of Parma in Gastronomic Sciences or Human Nutrition Sciences.
研究组 & 干预措施
Healthy-Sustainable Then Non-Sustainable Meal
Participants assigned to this sequence consumed the healthy-sustainable test meal during the first experimental visit and the non-sustainable test meal during the second experimental visit after a 7-day washout period.
干预措施: Healthy-Sustainable Test Meal (Other)
Healthy-Sustainable Then Non-Sustainable Meal
Participants assigned to this sequence consumed the healthy-sustainable test meal during the first experimental visit and the non-sustainable test meal during the second experimental visit after a 7-day washout period.
干预措施: Non-Sustainable Test Meal (Other)
Non-Sustainable Then Healthy-Sustainable Meal
Participants assigned to this sequence consumed the non-sustainable test meal during the first experimental visit and the healthy-sustainable test meal during the second experimental visit after a 7-day washout period.
干预措施: Healthy-Sustainable Test Meal (Other)
Non-Sustainable Then Healthy-Sustainable Meal
Participants assigned to this sequence consumed the non-sustainable test meal during the first experimental visit and the healthy-sustainable test meal during the second experimental visit after a 7-day washout period.
干预措施: Non-Sustainable Test Meal (Other)
结局指标
主要结局
Diet-Induced Thermogenesis
时间窗: Baseline and 0-240 minutes after test meal consumption during each experimental visit
Diet-induced thermogenesis will be calculated from postprandial energy expenditure measured by portable indirect calorimetry after consumption of each test meal.
Respiratory Quotient
时间窗: Baseline and 0-240 minutes after test meal consumption during each experimental visit
Respiratory quotient will be calculated from oxygen consumption and carbon dioxide production measured by portable indirect calorimetry at fasting baseline and during the postprandial period.
次要结局
- Repeated Hunger Scores Assessed Using a 100-Millimetre Visual Analogue Scale(From the fasting assessment before the standardised breakfast to 240 minutes after consumption of the test lunch, during each experimental visit.)
- Repeated Satiety Scores Assessed Using a 100-Millimetre Visual Analogue Scale(From the fasting assessment before the standardised breakfast to 240 minutes after consumption of the test lunch, during each experimental visit.)
- Repeated Fullness Scores Assessed Using a 100-Millimetre Visual Analogue Scale(From the fasting assessment before the standardised breakfast to 240 minutes after consumption of the test lunch, during each experimental visit.)
- Repeated Prospective Food Consumption Scores Assessed Using a 100-Millimetre Visual Analogue Scale(From the fasting assessment before the standardised breakfast to 240 minutes after consumption of the test lunch, during each experimental visit.)
- Repeated Desire for Sweet Food Scores Assessed Using a 100-Millimetre Visual Analogue Scale(From the fasting assessment before the standardised breakfast to 240 minutes after consumption of the test lunch, during each experimental visit.)
- Repeated Desire for Salty Food Scores Assessed Using a 100-Millimetre Visual Analogue Scale(From the fasting assessment before the standardised breakfast to 240 minutes after consumption of the test lunch, during each experimental visit.)
- Repeated Desire for Savoury Food Scores Assessed Using a 100-Millimetre Visual Analogue Scale(From the fasting assessment before the standardised breakfast to 240 minutes after consumption of the test lunch, during each experimental visit.)
- Repeated Desire for Fatty Food Scores Assessed Using a 100-Millimetre Visual Analogue Scale(From the fasting assessment before the standardised breakfast to 240 minutes after consumption of the test lunch, during each experimental visit.)
- Total Fluid Intake(Over the 24-hour study period associated with each experimental condition.)
- Total 24-Hour Urine Volume(Over the 24-hour urine-collection period associated with each experimental condition.)
- Morning Spot Urine Specific Gravity(At the fasting morning urine collection before breakfast during each experimental visit.)
- Urine Specific Gravity of the Pooled 24-Hour Urine Collection(At completion of the 24-hour urine-collection period associated with each experimental condition.)
- Urine Colour Score Assessed Using the Armstrong 8-Point Urine Colour Chart(At the scheduled urine collection time points during each 24-hour experimental condition.)
- Urinary Nitrogen Excretion(24-hour urine collection during each experimental condition)
- Urinary Creatinine Excretion(24-hour urine collection during each experimental condition)
研究者
Francesca Scazzina Ph.D.
full professor
University of Parma