Short and Long-Term Effects of Prebiotic, Probiotic and Synbiotic on Appetite and Dietary Intake
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Change in dietary energy and nutrient intakes by 3-day dietary record method
研究概览
简要总结
Prebiotics and probiotics are thought to play a role in appetite control and body weight regulation; but little is known about this topic. This study was planned to examine the effects of inulin and Lactobacillus casei 431 on short and long term fasting, satiety, dietary intake, and serum hunger and satiety hormone levels. The study consisted of 2 phases. In the first phase, a double-blind, randomized, crossover study design was used, and it was performed with 16 healthy male participants aged 19-30 years. In this phase, the prebiotic (200mL milk+16g inulin), probiotic (200mL milk + Lactobacillus casei 431 [>106 cfu/mL]+16g maltodextrin), synbiotic (200mL milk+16g inulin + Lactobacillus casei 431 [>106 cfu/mL]) and control (200mL milk+16g maltodextrin) test drinks were consumed with a standard breakfast on four separate test days by one week intervals, and their effects on dietary intake, hunger, satiety and appetite were assessed. The second phase was performed with 21 healthy male participants aged 19-30 years, using a placebo-controlled double-blind, randomized study design. Participants consumed the control (200mL milk+16g maltodextrin) or synbiotic (200mL milk+16g inulin+ Lactobacillus casei [>106 cfu/mL]) test drinks for 21 days with their habitual diet. At the beginning and end of the intervention, blood samples were collected at 0., 30., 60. and 120. minutes following the test day protocol to analyse serum glucose, insulin, ghrelin, obestatin and PYY (peptide tyrosine tyrosine) levels. In addition, dietary intake, hunger, satiety and appetite of participants were compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 30 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male
- •19-30 years old
- •Body mass index (BMI) of 18.5-29.9 kg/m2
排除标准
- •Being female
- •Being younger than 19 years old or older than 30 years old
- •Having a BMI that is lower than 18.5 kg/m2 or higher than 29.9 kg/m2
- •Having any metabolic disease
- •Losing or gaining weight in the past 3 months
- •Following a special diet
- •Using any medicine which could affect the outcome of the study
- •Having food intolerance and allergies
- •Taking regular probiotic or prebiotic foods or supplements
- •Not consuming breakfast or lunch regularly
- •Being a professional athlete
- •Having unhealthy eating attitude that assessed using three factor eating questionnaire (having cognitive restraint score >13, uncontrolled eating score >18, and emotional eating > 6)
- •Having depression that was assessed using Beck's Depression Inventory (having a score >9)
结局指标
主要结局
Change in dietary energy and nutrient intakes by 3-day dietary record method
时间窗: At the beginning and end of the intervention (Day 0 and Day 21)
Energy and nutrients intakes were assessed using a 3-day dietary record method at baseline (including the mean dietary intake of Day -3, Day -2 and Day -1) and at end of the intervention (including the mean dietary intake of Day 19, Day 20 and Day 21).
Change in appetite sensations
时间窗: 0., 30., 60., 90., 120. and 180. minutes at the beginning and end of the intervention (Day 0 and Day 21)
Appetite sensation was measured using 100-mm visual analog scale with a minimum value of 0 and a maximum value of 100 at six points including before the breakfast (0.) and following 30., 60., 90., 120. and 180. minutes. Lower scores mean a better outcome.
Change in body weight
时间窗: At the beginning and end of the intervention (Day 0 and Day 21)
Body weight was measured
次要结局
- Change in area under the serum glucose concentration versus time curve (AUC)(0., 30., 60. and 120. minutes at the beginning and end of the intervention (Day 0 and Day 21))
- Change in area under the serum insulin concentration versus time curve (AUC)(0., 30., 60. and 120. minutes at the beginning and end of the intervention (Day 0 and Day 21))
- Change in area under the serum obestatin concentration versus time curve (AUC)(0., 30., 60. and 120. minutes at the beginning and end of the intervention (Day 0 and Day 21))
- Change in area under the serum ghrelin concentration versus time curve (AUC)(0., 30., 60. and 120. minutes at the beginning and end of the intervention (Day 0 and Day 21))
- Change in area under the serum PYY concentration versus time curve (AUC)(0., 30., 60. and 120. minutes at the beginning and end of the intervention (Day 0 and Day 21))
- Change in serum fasting adiponectin concentration(At the beginning and end of the intervention (Day 0 and Day 21))
- Change in dietary energy and nutrient intakes by diet diary method(Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13, Day 14, Day 15, Day 16, Day 17, Day 18, Day 19, Day 20, Day 21)
研究者
ZEHRA BUYUKTUNCER
Professor in Nutrition and Dietetics
Hacettepe University