Fermented Plant-based Portfolio Diet 4 Metabolic Health (FermDiHealth)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- C-reactive protein
研究概览
简要总结
The primary objective of this study is to evaluate the metabolic effects of a high-fiber portfolio diet based on fermented plant-based foods compared to a corresponding non-fermented plant-based diet and a control diet (habitual diet). This will be assessed across gut microbiome profiles (high/low Prevotella), focusing on cardiometabolic risk factors, particularly inflammation.
A total of 100 men and women who meet all inclusion criteria and none of the exclusion criteria will be invited to participate. The study will employ a three-way randomized, controlled cross-over design, featuring six-week interventions separated by six-week washout periods. Participants will attend the clinic on 15 occasions, including screening visits.
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
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign of metabolic syndrome
- •Waist circumference > 102 cm/88 cm M/W and at least one of the following:
- •High density lipoprotein (HDL) ≤1.0 mmol/L men / HDL ≤1.3 mmol/L
- •Triglycerides ≥ 1,7 mmol/L
- •Blood pressure ≥130/85 mmHg
- •Fasting glucose ≥5.6 mmol/L
- •Other inclusion criteria:
- •Signed informed consent
- •Willingness to consume the intervention foods
- •Body mass index 25-35 kg/m2
- •Hemoglobin 120-160 g/L
- •Serum thyroid-stimulating hormone (S-TSH) <4 mIU/L
- •Serum C-reactive protein (S-CRP) <5 mg/L
- •Access to a -18⁰ C freezer
- •Any medication stable for the last 14 days.
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.
- •Following any weight reduction program or having followed one during the last 6 months
- •Food allergies or intolerances
- •History of stomach or gastrointestinal conditions (Inflammatory bowel disease, Crohn's disease, malabsorption, colostomy, bowel resection, gastric bypass surgery, Helicobacter infection, Peptic ulcer disease, untreated celiac disease, etc.)
- •Previous major gastrointestinal surgery
- •Pregnant or lactating or wish to become pregnant during the period of the study.
- •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.
- •Pharmacological medication with drugs known to affect the microbiota, e.g., antibiotics, within 6 months prior to baseline.
- •Intake of any probiotic pills or foods enriched in probiotics within 6 months prior to baseline.
- •Type I diabetes
- •Small bowel bacterial overgrowth
- •Diarrheal disease
- •Receiving pharmacological treatment for type II diabetes (treatments based on lifestyle interventions are acceptable, as long as it is compatible with the study protocol)
- •Using nicotine products on a daily basis (including chewing gum, patches, snus etc.)
- •History of heart failure or heart attack (TIA) within 1 year prior to screening
- •Thyroid disorder
- •Planned surgery within the next eight months
研究组 & 干预措施
Non-fermented plant-based foods
干预措施: Non-fermented plant-based foods (Dietary Supplement)
Fermented plant-based foods
干预措施: Fermented plant-based foods (Dietary Supplement)
Habitual diet
干预措施: Habitual diet (Other)
结局指标
主要结局
C-reactive protein
时间窗: 6 weeks
Investigate if c-reactive protein differs between the interventions fermented plant-based foods, non-fermented plant-based foods and the habitual diet.
次要结局
- Glucose(6 weeks)
- Insulin(6 weeks)
- Liver parameters(6 weeks)
- Glycaemic variability(2 weeks)
- Mixed meal tolerance test(1-day)
- Gut microbiome(6 weeks)
- Blood pressure(6 weeks)
- Blood lipid profile(6 weeks)
研究者
Rikard Landberg
Professor
Chalmers University of Technology