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临床试验/NCT04788069
NCT04788069已完成不适用

Effect of Sourdough Breads Consumption on Postprandial Responses, Satiety and Food Intake at Subsequent Meal

KU Leuven1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2021年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
KU Leuven
入组人数
43
试验地点
1
主要终点
Food intake at subsequent meal

研究概览

简要总结

During this project the effect of different types of sourdough breads consumption on satiety, energy intake at subsequent meal and postprandial metabolic responses, will be investigated.

详细描述

A 3-phase randomised cross-over trial will be applied consisting of 3 intervention periods of 2 weeks, with a test day performed at the last day of each intervention period. During each intervention period, participants will consume a fixed amount of test bread, replacing their regular bread, and they will keep food and stool diaries preceding each Test-day. Faecal samples will be collected before each Test-day. On the Test-day, participants will perform a gastric emptying breath test. Furthermore, blood samples and appetite ratings will be collected at regular time points after consumption of the test bread for measurement of glucose, insulin, gut peptides, short-chain fatty acids (SCFA) and blood lipids. Food intake will be assessed by offering the subjects a standard lunch to be consumed ad-libitum.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
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 18.5 - 25.0 kg/m2 at screening visit
  • •Regular eating pattern (3 meals per day on at least 5 days per week)
  • •Willingness to consume bread (180 g) on a daily base
  • •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)
  • •Intake of prescription medication
  • •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)

研究组 & 干预措施

Wholemeal bread

Active Comparator

Treatment with wholemeal bread

干预措施: Wholemeal bread (Dietary Supplement)

Sourdough bread

Active Comparator

Treatment with sourdough bread

干预措施: Sourdough bread (Dietary Supplement)

Bread with sourdough

Active Comparator

Treatment with bread with sourdough

干预措施: Bread with sourdough (Dietary Supplement)

结局指标

主要结局

Food intake at subsequent meal

时间窗: During test day 3 (240 minutes after ingestion of breakfast)

Weighted amounts of ad-libitum food offered minus the weighted leftovers

Appetite measurements

时间窗: During test day 3 (up to 4 hours)

Appetite in response to test meal, will be measured using 100 millimeter (mm) Visual Analogue Scales (VAS) 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).

Appetite measurements

时间窗: During test day 1 (up to 4 hours)

Appetite in response to test meal, will be measured using 100 millimeter (mm) Visual Analogue Scales (VAS) 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).

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) 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 1 (240 minutes after ingestion of breakfast)

Weighted amounts of ad-libitum food offered minus the weighted leftovers

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

  • Stool shape and consistency(4 days during intervention with each bread type (totally 3x4 days over a period of 10 weeks))
  • Blood lipids(During test day 3)
  • Insulin response(During test day 3 (up to 4 hours))
  • Incretin hormones(During test day 3 (up to 4 hours))
  • Short-chain-fatty-acids(1 time after intervention with each bread type (totally 3 times over a period of 10 weeks))
  • Gastric emptying rate(During test day 3 (up to 4 hours))
  • Free-living energy intake(4 days during intervention with each bread type (totally 3x4 days over a period of 10 weeks))
  • Change in Gut microbiota composition(1 time after intervention with each bread type (totally 3 times over a period of 10 weeks))
  • Oral processing behaviour(During test day 3 (up to 15 minutes))
  • Glucose response(During test day 3 (up to 4 hours))
  • Blood lipids(During test day 2)
  • Oral processing behaviour(During test day 1 (up to 15 minutes))
  • Oral processing behaviour(During test day 2 (up to 15 minutes))
  • Blood lipids(During test day 1)
  • Glucose response(During test day 1 (up to 4 hours))
  • Glucose response(During test day 2 (up to 4 hours))
  • Insulin response(During test day 1 (up to 4 hours))
  • Insulin response(During test day 2 (up to 4 hours))
  • Incretin hormones(During test day 1 (up to 4 hours))
  • Incretin hormones(During test day 2 (up to 4 hours))
  • Short-chain-fatty-acids(During test day 1 (up to 8 hours))
  • Short-chain-fatty-acids(During test day 2 (up to 8 hours))
  • Short-chain-fatty-acids(During test day 3 (up to 8 hours))
  • Gastric emptying rate(During test day 1 (up to 4 hours))
  • Gastric emptying rate(During test day 2 (up to 4 hours))

研究者

发起方
KU Leuven
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kristin Verbeke

Principal Investigator

KU Leuven

研究点 (1)

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