NCT06006416撤回3 期
Effect of Fenugreek Fibre (Trigonella Foenum-graecum) on the Gut Microbiome in an Adult Population - an Open Label, Self-controlled Trial
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Change in metagenomic profile of the gut microbiome
研究概览
简要总结
A open label, self-controlled trial to evaluate the effect of Fenugreek Fibre (Trigonella foenum-graecum) on the gut microbiome in generally healthy adults aged 18-65 years old.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and females aged 18-65 years old
- •Generally healthy
- •Able to provide informed consent
- •BMI > 25kg/m2
- •Agree not to participate in another clinical trial while enrolled in this trial
- •Agree not the change their diet or exercise while enrolled in this trial
排除标准
- •Unstable(1) or serious illness (e.g. kidney, liver, GIT, heart conditions, diabetes, thyroid gland function, lung conditions, chronic asthma and mood disorders or neurological disorders such as MS)
- •Current malignancy (excluding BCC) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years
- •Currently taking Coumadin (Warfarin), Heparin, Dalteparin, Enoxaparin or other anticoagulation therapy
- •Acute sickness experienced within the past 2 months
- •Current use of medications (e.g. antibiotics) or supplements (e.g. pre- and probiotics) that alter the microbiome or gut health. Any use during the trial will result in exclusion from the study.
- •Active smokers and/or nicotine or drug abuse
- •Chronic alcohol use (>14 alcoholic drinks week)
- •Allergic to any of the ingredients in the formula
- •Pregnant(2) or lactating woman
- •Females of child bearing potential not using a highly effective form of contraception(3,4) (i.e. methods which result in low failure rate, i.e. less than 1% per year, when used consistently and correctly like the oral contraception pill, birth control implant e.g. implanon(3,4))
- •People medically prescribed medications that would affect the immune and/or the inflammatory response (e.g. NSAIDs, steroids, antibiotics).
- •Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
- •Participants who have participated in any other related clinical study during the past 1 month
- •People with cognitive damage
- •People who have or have had treatment for cancer, HIV or chronic use of any dose of steroids (cream, tablet or inhalant) in the past year
- •An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments.
- •All female participants of child bearing potential will be required to take a urine pregnancy test prior to entry into the study.
- •Examples of acceptable forms of highly effective contraception include: Established use of oral, injected or implanted hormonal methods of contraception; Placement of an intrauterine device (IUD) or intrauterine system (IUS); Sterilised male partner (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate); True abstinence: When this is in line with your preferred and usual lifestyle
- •Examples of non-acceptable methods of contraception include: Condoms alone or double barrier; Periodic abstinence (e.g. calendar, ovulation, symptothermal, post ovulation); Withdrawal; Spermicide (as it is not approved as a method of contraception in Australia)
研究组 & 干预措施
Fenugreek Fibre
Experimental
Fenugreek Fibre - 2 x 10g powder per day with/in food
干预措施: Fenugreek Fibre (Drug)
结局指标
主要结局
Change in metagenomic profile of the gut microbiome
时间窗: Week 0, week 4 and week 16
Change in metagenomic profile of the gut microbiome as measured by 16s rRNA gene sequencing
次要结局
- Change in safety(Week 0, week 4 and week 16)
- Change in blood pressure(Week 0, week 4 and week 16)
- Change in gut function(Week 0, week 4 and week 16)
- Change in GST(Week, 0, week 4, week 8 and week 16)
- Height(Week 0, week 4 and week 16)
- Change in hip and weight circumference(Week 0, week 4 and week 16)
- Change in inflammation(Week, 0, week 4, week 8 and week 16)
- Change in GLP-1(Week, 0, week 4, week 8 and week 16)
- Change in glutathione(Week, 0, week 4, week 8 and week 16)
- Change in stress state(Week, 0, week 4, week 8 and week 16)
- Change in gut inflammation(Week 0, week 4 and week 16)
- Change in Homocysteine(Week, 0, week 4, week 8 and week 16)
- Change in quality of life(Week, 0, week 4, week 8 and week 16)
- Change in weight(Week 0, week 4 and week 16)
- Change in intestinal permeability(Week, 0, week 4, week 8 and week 16)
- Change in FABP(Week, 0, week 4, week 8 and week 16)
- Change in diet(Week 0 and Week 16 (completed for 3 consecutive days))
- Change in sleep quality(Week, 0, week 4, week 8 and week 16)
研究者
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