An Exploratory Study of the Effect of Premeal Consumption of Protein-enriched, Dietary Fiber-fortified Cereal Bar on Food Intake in Healthy Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Food intake
研究概览
简要总结
The aim of this study is to explore premeal protein-enriched bar effect in food intake in healthy subjects.
详细描述
Twenty healthy subjects will be recruited. Every subject will be randomized in 6 groups and studied on 3 separate days in random order with 1 week intervals. These participants will consume protein enriched bar, commercial cereal bar, or water followed by a standardized diet (gimbap). For study outcomes, food intake, appetite and satiety (visual analog scale), plasma glucose, and satiety related hormone will be measured. Blood sampling will be done before 15 min of breakeast, at the moment of start of breakfast (0 min), and then 30, 60, 90, 120 min. Plasma glucose levels, total/active GLP-1, ghrelin, total PYY will be measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI 18.5~35 kg/m2
- •Never diagnosed by diabetes
- •Fasting plasma glucose <=100mg/dl and HbA1c <6.0%
排除标准
- •Those who diagnosed by Type 1 or Type 2 diabetes
- •Allergy to wheat, flour, nuts, milk
- •Pregnancy/lactation
- •AST or ALT >2.5 times of upper normal reference range
- •eGFR <30 mL/min/1.73m2
- •Hb <10g/dl
- •History of GI surgery (except hemorrhoidectomy, appendectomy)
研究组 & 干预措施
Group 5
water->protein enriched bar->commercial cereal bar
干预措施: Protein-enriched bar, commercial cereal bar, or water (Dietary Supplement)
Group 2
protein enriched bar->water->commercial cereal bar
干预措施: Protein-enriched bar, commercial cereal bar, or water (Dietary Supplement)
Group 1
protein enriched bar->commercial cereal bar->water
干预措施: Protein-enriched bar, commercial cereal bar, or water (Dietary Supplement)
Group 3
commercial cereal bar->protein enriched bar->water
干预措施: Protein-enriched bar, commercial cereal bar, or water (Dietary Supplement)
Group 4
commercial cereal bar->water->protein enriched bar
干预措施: Protein-enriched bar, commercial cereal bar, or water (Dietary Supplement)
Group 6
water->commercial cereal bar->protein enriched bar
干预措施: Protein-enriched bar, commercial cereal bar, or water (Dietary Supplement)
结局指标
主要结局
Food intake
时间窗: 120min
grams and caloric intake of standardized gimbap
次要结局
- Appetite (visual analogue scale : score 1 to 10)(120min)
- Satiety (visual analogue scale : score 1 to 10)(120min)
- plasma glucose (mmol/L)(-15min, 0(breakfast), 30, 60, 90, 120 min)
- plasma active/total GLP-1 (pmol/L)(-15min, 0(breakfast), 30, 60, 90, 120 min)
- plasma total peptide YY (pg/ml)(-15min, 0(breakfast), 30, 60, 90, 120 min)
- plasma active ghrelin (ng/ml)(-15min, 0(breakfast), 30, 60, 90, 120 min)
研究者
Young Min Cho
Professor
Seoul National University Hospital