NCT03097237已完成不适用
High Fiber Rye Foods for Weight and Body Fat Reduction
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 242
- 试验地点
- 1
- 主要终点
- Difference in body fat mass
研究概览
简要总结
The overall aim of this study is to investigate whether a diet rich in rye fiber from wholegrain rye, compared to refined wheat, as part of a hypocaloric diet leads to larger weight loss and lower body fat content after 12 weeks of intervention. Furthermore the study will investigate the effect on appetite as a potential underlying mechanism for differences in weight loss and body fat reduction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI 27-35 kg/m2
- •Hb≥120g/l
- •Serum thyroid stimulating hormone (TSH) ≤4.00 mIU/L
- •Plasma low density lipoprotein cholesterol <5.3 mmol/L
- •Plasma triglycerides ≤1.8 mmol/L
- •Signed informed consent
- •Freezer capacity for 2 weeks bread provision
排除标准
- •Blood donation or participation in a clinical study with blood sampling within 30 days prior to screening visit and throughout the study
- •Unable to complete satisfactorily the 3-day weighted food record at screening visit
- •Unable to lose 0.5 kg or more during the run-in period for men and women not having menstruation during the run in period
- •Increased body weight, despite reported adherence to dietary intake for women with menstruation during the run-in period.
- •Using nicotine products on a daily basis (incl. chewing gum, patches, snus etc.)
- •Using e-cigarettes (regardless of nicotine content)
- •Following any weight reduction program or having followed one during the last 6 months prior to visit 1
- •Diastolic blood pressure 105 mm Hg at visit 1
- •Systolic blood pressure 160 mm at visit 1
- •History of stomach or gastrointestinal conditions (Inflammatory bowel disease, Crohn's disease, malabsorption, colostomy, bowel resection, gastric bypass surgery etc.)
- •More than 10 hours physical activity per week
- •History of heart failure or heart attack within 1 year prior to screening
- •Have type I diabetes
- •Receiving pharmacological treatment for type II diabetes (treatments based on life style interventions are acceptable, as long as they are compatible with the study protocol)
- •Previous gastrointestinal surgery
- •Thyroid disorder
- •History of drug or alcohol abuse
- •Stroke or transient ischemic attack (TIA) within 1 year prior to screening
- •Consumption of drugs aimed at weight management or drugs affecting body weight to a degree that is considered unsuitable for study participation by responsible physician (will be included in the list of allowed/disallowed medications)
- •Pregnant or lactating or wish to become pregnant during the period of the study.
- •Food allergies or intolerances
- •Vegetarian (due to the standardized meals for appetite measurements)
- •Unable to understand written and spoken Swedish
- •Lack of suitability for participation in the trial, for any reason, as judged by the medical doctor or PI.
结局指标
主要结局
Difference in body fat mass
时间窗: 12 weeks
Difference in body weight
时间窗: 12 weeks
次要结局
- Appetite measured by visual analogue scale (VAS) questionnaire(12 weeks)
- Fecal energy excretion by bomb calorimetry of 72h quantitative fecal collections.(12 weeks)
- Gut microbiota(6 and 12 weeks)
- Marker of Insulin resistance(6 and 12 weeks)
- Marker of glucose metabolism(6 and 12 weeks)
- Appetite regulation(6 and 12 weeks)
- Difference in body weight and body fat mass(6 weeks)
- Marker of inflammation(6 and 12 weeks)
- Appetite(6 and 12 weeks)
- Blood lipids(6 and 12 weeks)
研究者
Dr. Rikard Landberg
Professor
Chalmers University of Technology
研究点 (1)
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