ISRCTN14510401进行中（未招募）未知
The effect of dietary bioactives on gut microbiome diversity - a pilot study
Quadram Institute0 个研究点目标入组 27 人开始时间: 2021年2月8日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 27
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Males and females aged 18 - 65 years old
- •2. BMI between 18.5 and 35 kg/m²
- •3. HbA1c below 42 mmol/mol
- •4. Access to a personal smart mobile phone enabled with near field communication (NFC) technology (this technology allows contactless card payments)
- •5. Living in an area which can receive a supermarket delivery
排除标准
- •1. Smokers (or stopped smoking for less than 3 months)
- •2. Having diabetes, defined as HbA1c =48 mmol/mol or pre-diabetes, defined as HbA1c 42 – 47 mmol/mol
- •3. Prescribed and non-prescribed medications that may affect the outcome measures for this study e.g. statins, laxatives
- •4. Dietary supplements judged to affect the study data unless the participant is willing to discontinue them 4 weeks before the start of the study and for the duration of the study
- •5. Use of antibiotics in the 6 months prior to the study
- •6. Regular/recent use of colonic irrigation or other bowel cleansing techniques
- •7. Use of pre/probiotics or fermented foods such as Yakult, Kefir products, unless the participant is willing to discontinue use 4 weeks before the start of the study and for the duration of the study
- •8. Bowel movements =3 times per week
- •9. Gastrointestinal diseases (excluding hiatus hernia unless symptomatic or study intervention/procedure is contraindicated)
- •10. History of inflamed bowel (ulcerative colitis, Crohn’s disease or diverticulitis)
- •11. Immune-related conditions associated with altered microbiome – lupus, type 1 diabetes, multiple sclerosis, poorly controlled thyroid disorders (Greaves disease, Hashimoto’s disease), rheumatoid arthritis
- •12. Parallel participation in another research project
- •13. Unwillingness to adhere to the dietary guidelines for the study
- •14. Participation in another research project which has involved blood sampling within the last 4 months unless the total amount of combined blood from both studies does not exceed 470 ml
- •15. Has donated or intends to donate blood within 16 weeks prior to or during the study period
- •16. Any person related to or living with any member of the study team
- •17. Those who are part of the line management or supervisory structure of the Chief Investigator
- •18. Lack of capacity to provide written informed consent
- •19. Are pregnant or have been pregnant within the last 12 months
- •20. Participants following a vegetarian or vegan diet, as restrictions to bioactive-rich foods (fruits and vegetables) during the study may be too limiting
- •21. Clinical eligibility test results deemed by the CRF medical advisor to be indicative of a health problem which may compromise the well-being of the participant or which could affect the study outcome
- •22. Being susceptible to food allergies and intolerances
- •23. Active infection with COVID-19
研究者
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