NCT02491125已完成不适用
Effect of Prebiotic Fibre on Intestinal Health and Functioning
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 主要终点
- Whole gut transit time [hours]
研究概览
简要总结
The study will investigate the effect of cereal based prebiotic fibres on intestinal health and functioning and host metabolism.
详细描述
A human dietary intervention study will be performed in overweight to obese subjects with a slow gastrointestinal transit time comparing the effects of a soluble prebiotic fibre vs. placebo on gut health, including gut microbiota composition, gastrointestinal transit time, metabolic health and quality of life.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Overweight to obese men and women (BMI ≥ 25 kg/m2 <35 kg/m2)
- •Aged 20-50 years
- •Caucasian
- •Normal fasting glucose (<6.1 mmol/L.)
- •Normal blood pressure (systolic blood pressure 100-140 mmHg, diastolic blood pressure 60-90 mmHg)
- •Weight stable in last 3 months (±2 kg)
- •A low defecation frequency, <4 times/week and no constipation or underlying pathology, as determined by gastro-intestinal questionnaires).
- •A slow whole gut transit (>35h)
排除标准
- •Woman lactating, pregnant (where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test) or (post)-menopausal
- •Regular smokers
- •People with intensive fitness training, eg. athletes (≥3 per week ≥ 1 hour training)
- •Diabetes Mellitus (defined as FPG ≥ 7.0 mmol/l and or 2h PG ≥ 11.1 mmol/l)
- •Gastro-intestinal diseases or abdominal surgery, cardiovascular diseases, cancer, liver or kidney malfunctioning (determined based on ALAT and creatinine levels, respectively) disease with a life expectation shorter than 5 years
- •Following a hypocaloric diet
- •Gluten intolerance
- •Regular use of laxation products, or use of antibiotics, probiotics or prebiotics 3 months prior to the start of the study
- •More than 2 symptoms occurring over a period of 12 weeks in the preceding 12 months such as
- •Straining in >1/4 defecations;
- •Lumpy or hard stools in >1/4 defecations;
- •Sensation of incomplete evacuation in >1/4 defecations;
- •Sensation of anorectal obstruction/blockade in >1/4 defecations
- •Manual maneuvers to facilitate >1/4 defecations (e.g., digital evacuation, support of the pelvic floor); and/or
- •<3 defecations/week
- •Current use of medication interfering with study intervention or interfering with study endpoints/hypotheses
- •Not to be able to understand the study information
- •Blood donation 2 months prior to the study and during the study
- •Participation in other studies
研究组 & 干预措施
Placebo
Placebo Comparator
12 weeks placebo maltodextrin 15g/day ( 5 g in beverage, to be consumed three times a day)
干预措施: Placebo (Dietary Supplement)
soluble wheat bran fibre
Experimental
12 weeks soluble wheat bran fibre 15g/day (5 g in beverage, to be consumed three times a day)
干预措施: soluble wheat bran fibre (Dietary Supplement)
结局指标
主要结局
Whole gut transit time [hours]
时间窗: measured at baseline at week 1 and directly after the 12 week supplementation
Whole gut transit time as measured by radio-opaque marker method
次要结局
- Oro-cecal transit time [min](measured at baseline at week 1 and directly after the 12 week supplementation)
- Defecation frequency (bowel movement per day)(measured at baseline at week 1 and directly after the 12 week supplementation)
- Energy expenditure(measured at baseline at week 1 and directly after the 12 week supplementation)
- Substrate oxidation(measured at baseline at week 1 and directly after the 12 week supplementation)
- Fecal Short chain fatty acid concentrations(measured at baseline at week 1 and directly after the 12 week supplementation)
- Plasma short chain fatty acid concentrations(measured at baseline at week 1 and directly after the 12 week supplementation)
- Gastric emptying [min](measured at baseline at week 1 and directly after the 12 week supplementation)
- Plasma inflammatory cytokines Interleukin-6,8 and 1 (pg/ml)(measured at baseline at week 1 and directly after the 12 week supplementation)
- Adipose tissue gene expression(measured at baseline at week 1 and directly after the 12 week supplementation)
- Gut permeability(measured at baseline at week 1 and directly after the 12 week supplementation)
- Microbiota composition(measured at baseline at week 1 and directly after the 12 week supplementation)
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