NL-OMON43887撤回不适用
Effects of oral riboflavin supplementation on the growth of Faecalibacterium prausnitzii and the impact on the gut microbiota: A randomized, double-blind, placebo-controlled human intervention trial. - Riboflavin in human Gut (RIBO-GUT).
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 105
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
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Males or Females, age 20 - 60 years.
- •2. Participant is willing to stick to its normal habitual diet excluding consumption of any unusual high energy-rich or fat-rich meals or prolonged fasting, etc. throughout the study period.
- •3. Participant is willing to maintain its habitual physical activity patterns throughout the study period.
- •4. Participant has been stable in body-weight within the last 6 months.
- •5. Participant has no health conditions that would prevent him/her from fulfilling the study requirements as judged by the investigator on the basis of medical history and routine laboratory test results.
- •6. Participant has a body mass index (BMI) of >=18.5 and <= 24.9 kg/m2 at screening.
- •7. Participant is willing to refrain from consuming alcoholic drinks 24 h prior to test days (V2-V3).
- •8. Participant is not smoking.
- •9. Participant is able and motivated to comply with protocol requirements like for instance take the investigational product the way it is prescribed and to do the tests.
- •10. Participant understands the study procedures and signs forms providing informed consent to participate in the study.
排除标准
- •1. Participant has abnormal clinical chemistry and haematology laboratory test results of clinical significance that in the judgment of the investigator would interfere with the participant*s ability to comply with the study protocol (which might confound the interpretation of the study results), or put the participant at undue risk.
- •2. Participants with a history of GI disorders that are likely to interfere with the mode of action of the test product.
- •3. Participant has donated more than 300 mL of blood during the three months prior to screening.
- •4. Participant has a history, in the judgment of the investigator, of a psychological illness or condition such as to interfere with the participant*s ability to understand the requirements of the study.
- •5. Use of antibiotics or signs of active systemic infection in the last 6 months.
- •6. Participants who are on hypocaloric/hypercaloric diet aiming for weight loss/gain.
- •7. Participant has a history or presence of cancer in the prior two years, except for non-melanoma skin cancer.
- •8. Participant is pregnant, planning to be pregnant during the study period, lactating, or women of childbearing potential who are unwilling to commit to the use of a medically approved form of contraception throughout the study period. The method of contraception must be recorded in the source documentation.
- •9. Regular use of dietary supplements e.g. riboflavin, fish oil, 1 month prior study inclusion.
- •10. Participant has had exposure to any non-registered drug product within 30 days prior to the screening visit.
- •11. Recent history of (within 12 months of screening visit) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as >60g (men) / 40g (women) pure alcohol per day (1.5 l / 1 l beer resp. 0.75 l / 0.5 l wine).
- •12. Participant has a known allergy or sensitivity to study product or any ingredients of the study product.
- •13. Use of commercially available probiotic, prebiotic and other supplements that may affect the gut microbiota
研究者
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