NCT05590611招募中不适用
Impact of Sourdough Bread Consumption on Long-term Energy Intake: A Pilot Study of Feasibility (SOBER)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- KU Leuven
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Energy intake (kilocalories)
研究概览
简要总结
The present study is a pilot study examining whether long-term sourdough bread consumption reduces energy intake and blood lipids levels over a period of 4 weeks in free-living normalweight and overweight participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, 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 >20 kg/m2 at screening visit
- •Regular eating pattern (3 meals per day on at least 5 days per week)
- •Habitual brown bread consumption of at least 1 slice per day (assessed by The European Prospective Investigation into Cancer (EPIC) Norfolk FFQ)
- •Stable body weight for the last 6 months
排除标准
- •Currently smoking or willingness to smoke during the study period
- •Pregnancy, lactation or wish to become pregnant during the study period
- •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
- •Allergy/intolerance to milk, egg, nuts, soy or sesame
- •Habitual sourdough bread consumption of at least 1 slice per day (assessed by The European Prospective Investigation into Cancer (EPIC) Norfolk FFQ)
- •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)
研究组 & 干预措施
Brown Bread
Placebo Comparator
干预措施: Dietary Intervention with Brown Bread (Other)
Wholemeal Sourdough Bread
Active Comparator
干预措施: Dietary Intervention with Sourdough Bread (Other)
结局指标
主要结局
Energy intake (kilocalories)
时间窗: 4 weeks
Assessed via 4-day food diaries using a mobile app
次要结局
- Body weight(4 weeks)
- Blood lipid levels(4 weeks)
研究者
研究点 (1)
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