NCT07110896招募中不适用
A Randomized, Placebo-controlled, Double-blind Clinical Study to Evaluate the Effect of Humiome® Post LB on Stress, Anxiety, and Cognition in Aging Adults
dsm-firmenich Switzerland AG3 个研究点 分布在 2 个国家目标入组 236 人开始时间: 2025年8月1日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 236
- 试验地点
- 3
- 主要终点
- Effect on stress
研究概览
简要总结
To assess the effect of 3 months of daily consumption of a postbiotic (inactivated lactic acid bacteria) Humiome® Post LB on stress measured by the Depression Anxiety Stress Scale-21 (DASS-21) adjusted on baseline in study participants when compared to placebo
详细描述
A double-blinded, randomised and placebo-controlled study will be conducted to assess the effect of 3 months of daily consumption of a postbiotic (inactivated lactic acid bacteria), Humiome® Post LB, on stress measured by the Depression Anxiety Stress Scale-21 (DASS-21) adjusted for baseline in study participants when compared to placebo.
The study will be in healthy subjects who are getting older (ageing population) and will measure factors such as stress, sleep, anxiety as well as gut microbiome. The intervention period will be 90 days, and study will include 236 subjects in two arms (active and placebo),
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant is male or female, 50-75 years of age, inclusive.
- •Participant has a Body Mass Index (BMI) of ≥18.5 kg/m2 to 32 kg/m
- •Participant is generally in good health, as per investigator's judgement at V
- •Participant has subjective mild to moderate memory complaints, as per investigator's judgement.
- •Participant has a total score of ≥42 and ≤60 on the DASS-21 administered at V
- •Participant is willing to maintain regular dietary, exercise, and allowed medication/supplement habits and smoking and other nicotine habits (if a smoker or nicotine user) for the duration of the study.
- •Participant understands the study procedures and signs forms documenting informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator.
- •7. Participant understands the study procedures and signs forms documenting informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator.
排除标准
- •Participant has a history or presence of a psychiatric or neurologic disease including epilepsy, cerebrovascular disease, traumatic brain injury, dementia, Alzheimer's Disease, clinical depression, or other clinically significant psychiatric/neurologic condition that, in the opinion of the investigator, could interfere with the interpretation of the study results.
- •MMSE score at V1 <
- •Chronic fatigue syndrome.
- •Women: elevated stress and/or anxiety levels clearly related to the (peri) menopause complaints, as per investigator judgement
- •Non-pharmacological or non-supplementation options for management of stress, anxiety or memory/cognitive complaints (e.g. yoga, "brain jogging") started within 4 weeks of screening
- •Participant has a clinically significant gastrointestinal, endocrine, cardiovascular, renal, hepatic, pulmonary, pancreatic, neurologic, or biliary disorder that, in the opinion of the investigator, could interfere with the interpretation of the study results.
- •7. Participant has a condition that would likely cause immunosuppression.
- •Participant has a history of gastrointestinal surgery (cholecystectomy and appendectomy are acceptable, considering the prevalence in the age group), as per investigator judgement.
- •Participant has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥100 mm Hg) at screening.
- •10. Participant has an issue with hearing or seeing that might interfere with the tasks/questionnaires to be completed during the visits.
- •11. Participant has used pre-, pro-, syn-, or post-biotic supplements within 90 days of screening.
- •12. Participant has a history of using psychotropic medications (including antidepressants and tranquilizers), stimulant medications, and/or narcotics within 4 weeks of screening.
- •Participants has major sleep disorder (severe insomnia) based on investigator's judgment.
- •14. Participant has used sleep aid medications, supplements, and/or products, including antihistamines, within 2 weeks of screening (washout prior to screening is allowed). Sporadic use of supplementation of melatonin, valerian, passion flower, lavender, if needed, if this has been habitually or occasionally done prior to the study, is allowed.
- •Participant has used an acid-blocking medication (e.g., proton pump inhibitor, H2 blocker) in the past 30 days prior to study. However, any ongoing use started at least 12 weeks before Visit 1 is allowed.
- •16. Participant has used selective serotonin reuptake inhibitors (SSRIs) or benzodiazepines in the past 30 days. (Note: Participants will not be excluded on the basis of a well-managed depressive disorder that does not require SSRIs.)
- •Participant has a history of cancer in the prior 5 years.
- •Participant has an allergy to any components of the IP or the standardized breakfast.
- •19. Individual has signs or symptoms of an active infection of clinical significance or has taken antibiotics within 30 days prior to any visit (washout is permitted for re-scheduling of the clinic visit).
- •20. Participant has been exposed to any non-registered drug product within 30 days of the screening visit.
- •21. Participant has a current or recent history (within 12 months of screening) or strong potential for illicit drug or excessive alcohol intake defined as >14 drinks per week (1 drink = 350 ml beer, 150 ml wine, or 40 ml hard liquor).
- •22. Women lactating, pregnant or of childbearing potential not using a reliable contraceptive method.
- •23. Participant has a condition the investigator believes would interfere with his/her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.
研究组 & 干预措施
Active
Active Comparator
Humiome Post LB (Postbiotic) : 340mg in 2 identical capsules per day orally
干预措施: Humiome Post LB (Postbiotic) (Dietary Supplement)
Placebo
Placebo Comparator
Microcrystalline in 2 identical capsules per day orally
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Effect on stress
时间窗: Timeframe - Day 0 (V2), and Day 90 (V4)
To assess the effect of 3 months of daily consumption of Humiome® Post LB on stress measured by the Depression Anxiety Stress Scale-21 (DASS-21) adjusted on baseline in study participants when compared to placebo
次要结局
- Effect on stress (within the group)((Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4))
- Effect on stress (within the group, compared to baseline)((Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4))
- Effect on indicators of Anxiety(Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4))
- Effect on indicators of perceived stress(Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4))
- Effect on Indicators of cognition and memory(Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4))
- Effect on stress (adjusted to baseline)(Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4))
- Effect on indicators of Chronic inflammation (hs-CRP) in blood(Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4))
- Effect on indicators of Chronic inflammation (homocysteine) in blood(Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4))
- Effect on indicators of Chronic inflammation (BDNF) in blood(Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4))
- Effect on indicators of Chronic inflammation (IL-11) in blood(Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4))
- Effect on indicators of Chronic inflammation (IL-6) in blood(Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4))
- Effect on indicators of Chronic inflammation (IL-10) in blood(Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4))
- Effect on indicators of Chronic inflammation (TNF-α) in blood(Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4))
- Effect on indicators of Chronic inflammation in feces(Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4))
研究者
研究点 (3)
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