The ACTivating Fat OXidation Through Capsinoids (ACTIFOX) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Change in energy expenditure (kcal/day) by indirect calorimetry (CPX Ultima CardioO2 system)
研究概览
简要总结
Prior evidence suggests that capsinoids ingestion may increase resting energy expenditure (EE) and fat oxidation (FATox) in humans, although whether they can modulate those parameters during exercise conditions remains poorly understood. Investigators aimed to determine the effects of dihydrocapsiate (DHC) ingestion on EE and FATox during an acute bout of aerobic exercise at FATmax intensity (the intensity that elicits maximal fat oxidation [MFO] during exercise) in overweight/obese men.
A total of 24 sedentary overweight/obese men participated in this randomized, triple-blinded, placebo-controlled, crossover trial. On the first day, participants underwent a submaximal exercise test in a cycloergometer to determine their MFO and FATmax intensity during exercise. After 72 hours had elapsed, the participants returned in 2 further days (≥ 72 hours apart) and performed a 60 min steady-state test (SST, i.e., cycling at their FATmax, constant intensity) after ingesting either 12 mg of DHC or placebo; these conditions were randomized. Respiratory gas exchange was monitored by indirect calorimetry. Serum markers concentrations (glucose, triglycerides, and non-esterified fatty acids), skin temperature, thermal perception, heart rate and perceived fatigue were assessed as secondary outcomes.
详细描述
The study protocol and design have been approved by the Human Research Ethics Committee of the University of Granada (n°839/CEIH/2019) and the Servicio Andaluz de Salud and adhered to the tenets of the Declaration of Helsinki as revised in 2013.
Participants were asked to confirm having commuted to the research center by car, bus, tram, or motorcycle, having slept, as usual, having refrained from stimulant beverages within 24 h, and having avoided any moderate or vigorous physical activity within 24 h and 48 h (respectively).
METHODS SUMMARY
Briefly, in the first visit, sociodemographic and lifestyle data were registered, and medical screening was performed, blood samples were collected, and anthropometry and body composition measures were taken. On the second visit, the MFO during exercise and cardiorespiratory fitness (peak volume of oxygen consumption, VO2 peak) were respectively assessed through a submaximal exercise test coupled to a maximal effort test. On visits third and fourth, participants performed a 60 min steady-state exercise bout on a cycle ergometer at FATmax intensity (i.e., at the intensity at which MFO is elicited) after having ingested either 12 mg of DHC or placebo. The conditions (DHC or placebo) on visits 3 and 4 were randomized. The washout period between visits 3 and 4 was ≥72 h. Of note, all exercise tests took place at a strictly controlled temperature of 22-23 ºC, given that environmental temperature largely influences EE and FATox.
EXTENDED METHODS
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •to be male
- •to be 18-55 years old
- •to be sedentary (<20 min moderate-to-vigorous physical activity on <3 days/week)
- •to be non-smoker
- •not to be under medication
- •to have a stable body weight over the preceding three months (<3 kg change)
排除标准
- •having been diagnosed with diabetes, hypertension, or any medical condition(s) that can interfere with or be aggravated by exercise
- •using medication that could affect energy metabolism
- •present a family history of CVD
- •to have an abnormal electrocardiogram, regular and high consumption of spicy foods
- •being frequently exposed to cold temperatures (e.g., indoors/outdoors workspace with low-temperatures, such as cold-storage works, ski/snow monitors, fieldworks during the winter sessions or low-temperatures areas)
结局指标
主要结局
Change in energy expenditure (kcal/day) by indirect calorimetry (CPX Ultima CardioO2 system)
时间窗: It will be continuously measured through the 60 minutes-bout of aerobic exercise at FATmax intensity
Change in fat oxidation (g/min) by indirect calorimetry (CPX Ultima CardioO2 system)
时间窗: It will be continuously measured through the 60 minutes-bout of aerobic exercise at FATmax intensity
次要结局
- Change in serum levels of glucose (mg/dL) by automated analyzer (Beckman Coulter)(It will be measured at timepoints 0, 15, 30, 45 and 60 minutes, of the 60 minutes-bout of aerobic exercise at FATmax intensity)
- Change in serum levels of triglycerides (mg/dL) by automated analyzer (Beckman Coulter)(It will be measured at timepoints 0, 15, 30, 45 and 60 minutes, of the 60 minutes-bout of aerobic exercise at FATmax intensity)
- Change in serum levels of non-esterified fatty acids (mmol/L) by automated analyzer (Beckman Coulter)(It will be measured at timepoints 0, 15, 30, 45 and 60 minutes, of the 60 minutes-bout of aerobic exercise at FATmax intensity)
- Change in skin temperature (ºC) by iButtons wireless thermometers(It will be continuously measured through the 60 minutes-bout of aerobic exercise at FATmax intensity)
- Change in thermal perception (unitless) by ASHRAE scales(It will be measured every 15 minutes of the 60 minutes-bout of aerobic exercise at FATmax intensity)
- Change in rated perceived exertion (unitless) by RPE scales(It will be measured every 5 minutes of the 60 minutes-bout of aerobic exercise at FATmax intensity)
研究者
Jonatan Ruiz Ruiz
Professor
Universidad de Granada