Food Intake and Thermogenesis in High Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Diet induced thermogenesis (DIT)
研究概览
简要总结
The purpose of this research is to determine the effects of food on cardiovascular and metabolic health in men with and without spinal cord injury (SCI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •SCI and Controls
- •Physically inactive (<150 minutes per week of moderate-vigorous activity intensity for the preceding 3 months)
- •Weight stable: body mass ±3 kilograms (kg) for past 3 months
- •Chronic SCI (≥ 1-year post-injury)
- •Motor-complete SCI American Spinal Injury Association Impairment Scale (AIS) A and B
- •T6 injuries and above that can independently feed themselves
排除标准
- •SCI and Controls
- •Uncompensated thyroid disease
- •Swallowing or gastrointestinal pathologies
- •Allergies or aversions to foods/ingredients
- •Prescribed prokinetic, antipsychotic, or anti-obesity agents
- •Incomplete SCI AIS C or D
- •Ventilator-dependent
研究组 & 干预措施
Low meal condition group
Subjects will be in this group for up to 3 weeks.
干预措施: Low meal condition (Other)
Low meal condition group
Subjects will be in this group for up to 3 weeks.
干预措施: Ad-libitum control condition (Other)
Moderate meal condition group
Subjects will be in this group for up to 3 weeks.
干预措施: Moderate meal condition (Other)
Moderate meal condition group
Subjects will be in this group for up to 3 weeks.
干预措施: Ad-libitum control condition (Other)
High meal condition group
Subjects will be in this group for up to 3 weeks.
干预措施: High meal condition (Other)
High meal condition group
Subjects will be in this group for up to 3 weeks.
干预措施: Ad-libitum control condition (Other)
结局指标
主要结局
Diet induced thermogenesis (DIT)
时间窗: up to 3 weeks (collected during each of the intervention visits)
Diet-induced thermogenesis (DIT) will be measured using indirect calorimetry. A portable mask-based metabolic system, which will measure expired air to calculate dietary-induced thermogenesis defined as the energy expended above resting and the proportion of meal energy expended postprandially (postprandial kilocalorie (kcal) expended/total meal kcal) where a higher value means more energy is expended.
Hunger Series Visual Analog Scale
时间窗: up to 3 weeks (collected during each of the intervention visits)
Satiety will be measured using the Hunger Series Visual Analog Scale (HSVAS), which assesses subjective appetite. Each scale is defined at 0 as "not at all hungry" and 100 as "totally/a lot/very hungry". A sum score will be calculated.
Post ad-libitum energy intake measured in grams
时间窗: up to 3 weeks (collected during each of the intervention visits)
This value will be expressed as a ratio of energy consumed to energy requirements (energy intake/energy requirements x 100) and will be recorded in grams.
次要结局
未报告次要终点
研究者
Gary Farkas
Assistant Professor
University of Miami