Effect of Sourdough Bread Consumption on Postprandial Responses, Appetite Regulation and Energy Intake at the Subsequent Meal (SPAR Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- KU Leuven
- 入组人数
- 47
- 试验地点
- 4
- 主要终点
- Appetite measurements
研究概览
简要总结
During this project the effect of yeast bread and sourdough breads consumption on satiety, energy intake at subsequent meal and postprandial metabolic responses, will be investigated.
详细描述
The primary aim of this study will be to evaluate the impact of an alternative starter culture that produces high levels of lactic acid on appetite regulation (subjective satiety and energy intake at the subsequent meal). The second aim will be to identify mechanistic parameters that may explain the observed effects, including glycaemic and insulin response, and gastric emptying rate. In addition, habitual physical activity levels, and mood and stress levels of the subjects will be evaluated as potential covariates of appetite regulation.
It is hypothesized that:
Sourdough breads fermented with the alternative starter culture that produce high concentrations of lactic acid will reduce glucose response via lower starch digestibility and/or slower gastric emptying rate. The reduced glycaemic response will lead to higher satiety and lower energy intake at the subsequent meal (more than 10%).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Female and male participants
- •age range 18 - 50
- •BMI range 18.5 - 25.0 kg/m2 at screening visit
- •Regular eating pattern (3 meals per day on at least 5 days per week)
- •Stable body weight for the last 6 months
排除标准
- •Currently smoking (has smoked in the last 28 days) or willingness to smoke during the study period
- •Pregnancy, lactation or wish to become pregnant during the study period
- •Family history of diabetes
- •Previous or current gastrointestinal or endocrine disorders
- •Previous or current substance/alcohol dependence or abuse (> 2 units per day/14 units per week)
- •Coeliac disease or gluten sensitivity
- •Use of pre- or probiotics within one month preceding the study
- •Use of antibiotics within 3 months preceding the study
- •Excessive concern about eating habits or body weight as evidenced from scores < 18 on the restraint and disinhibition subscales of the Three-Factor Eating Questionnaire (Stunkard & Messick, 1985)
结局指标
主要结局
Appetite measurements
时间窗: During test day 2 (up to 4 hours)
Appetite in response to test meal, will be measured using 100 millimeter (mm) Visual Analogue Scales (VAS), with 0 being the minimum value (not at all) and 100 being the maximum value (extremely). Measurements will be taken: before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240 minutes).
Food intake at subsequent meal
时间窗: During test day 2 (240 minutes after ingestion of breakfast)
Weighted amounts of ad-libitum food offered minus the weighted leftovers
次要结局
- Glucose response(During test day 2 (up to 4 hours))
- Mood related questionnaires - The Positive and Negative Affect Schedule (PANAS scale)(At the end of test day 2)
- Insulin response(During test day 2 (up to 4 hours))
- Gastric emptying rate(During test day 2 (up to 4 hours))
- Subjective stress ratings(During test day 2 (up to 4 hours))
- Physical activity questionnaire(At the end of test day 2)
- Mood related questionnaires - Perceived Stress Scale - 10 items (PSS-10)(At the end of test day 2)
- Mood related questionnaires - Depression, Anxiety, Stress Scales - 21 items (DASS-21)(At the end of test day 2)