A Randomized, Double Blind, Placebo Controlled Parallel Study to Assess the Effects of a Triglyceride on Adults with Low to Moderately Low Mood.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- To evaluate the effect of eight weeks consumption of triglyceride supplement compared to Placebo on low mood in a population with self-reported mild to moderate symptoms (Hospital Anxiety and Depression Scale - Depression, HADS-D score of 8 - 14).
研究概览
简要总结
Trillions of microbes reside in human gut and constitute "gut microbiota". Composition of these microbes and substances produced by them play an important role in human health and wellness.
The goal of this study is to determine if a unique orally consumed triglyceride supplement will impart mood benefits. Investigators hypothesize that a part of the fatty acids will be released in upper gastrointestinal (GI) tract and can be absorbed and reach different organs via systemic circulation (blood), including to the brain, and provide health benefits. Rest of the portion would reach the colon and may modulate gut microbiota and provide health benefits via the gut-brain axis (a bi-directional communication between emotional and cognitive centers and the gastrointestinal system). These health benefits could include alleviation of stress, occasional anxiousness and low mood.
Participants with self-reported low mood will be randomized to two groups - one group will receive triglyceride supplement in softgel form and another group will receive a placebo (softgel with no active substance). Investigators will evaluate the effect of consumption of triglyceride supplement compared to Placebo on occasional low mood, occasional anxiousness, stress, sleep and general health by measuring changes from baseline.
详细描述
This is a randomized, placebo-controlled, double-blind, parallel study, which will include 5 visits over 10 week period - a screening visit (Visit 1; week -3), a 3-week run-in period followed by baseline determination or baseline visit (Visit 2; day 0), and three test visits (Visits 3, 4, and 5 at days 14, 28, and 56 respectively).
SCREENING
Visit 1 - Week -3
At Visit 1 (Screening visit) Participants will attend the study site and the following procedures will be carried out:
- Participants will receive oral and written information about the study and be allowed to ask questions.
- Participants will sign the informed consent document.
- Inclusion and exclusion criteria will be reviewed.
- Demographic, health, and lifestyle data will be collected.
- Medical history will be collected.
- Concomitant medication will be recorded.
- Height and weight will be measured, and Body Mass Index (BMI) calculated.
- Vitals (blood pressure, heart rate and temperature) will be recorded.
- Complete Block Fiber screener
- Download the Electronic Patient Reported Outcomes (ePRO) questionnaire app to the participants device.
- Complete Hospital Anxiety and Depression (HADS) questionnaire.
- A blood sample will be collected for screening and safety analysis.
- For participants of childbearing potential, a urine sample will be collected, and pregnancy test performed (regardless of contraceptive use or relationship status).
- Participants will be provided with a stool collection kit and instructions for collecting and storing their sample. Participants will collect a stool sample at home, within 48 hours of their scheduled visit and bring it to the clinic at their next visit.
- Participants will be provided with a saliva collection kit and instructions for collecting and storing their sample. Participants will collect a saliva sample at home, at T0, T30, T45, T60 minutes after waking on the morning of their scheduled visit and bring it to the clinic at their visit.
- Participants will be provided with the Karolinska Sleepiness Scale (KSS). Participants will complete this 5 minutes after collecting T0 saliva sample on the morning of their scheduled visit and bring it to the clinic at their visit.
- Participants will be provided with a 3-day food diary and instructions on how to complete the document. Participants will return their completed diary at their next visit.
- Participants will be reminded to complete the questionnaires with 24 hours of their next visit.
- Participants will be provided with a provisional appointment to attend a Dual X-ray absorptiometry (DEXA) scan.
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
- Double (Participant, Investigator)
盲法说明
Blinding of both study team and participants will be ensured by only providing access to the randomization list to the science and quality team. The relationship between the randomization number and the group assignment will be unknown to the participants, clinical study team, and the Sponsor, i.e. the study will be double-blinded.
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
- 是
入选标准
- •To be eligible for inclusion, the Participant must fulfil all the following criteria:
- •Be willing to participate in the study and comply with its procedures.
- •Be able to give written informed consent.
- •Adults aged between 18 and 65 years (inclusive).
- •Participants with a BMI between ≥18.5 and <30.0 kg/m^
- •Has self-reported mild-moderate low mood, confirmed by a Hospital Anxiety and Depression Scale (HADS - D) score 8 -
- •Be willing to maintain stable dietary habits and physical activity levels throughout the study period.
- •Be able to communicate well with the Investigator, to understand and comply with the requirements of the study and be judged suitable for the study in the opinion of the Investigator.
排除标准
- •Participants will be excluded from the study if they meet any of the following criteria:
- •Recent use of probiotics, prebiotics, postbiotic and other fermented foods that contain live bacteria within last 30 days from Visit
- •Recent use of any dietary supplements, within last 14 days from Visit
- •Participant who has been on antibiotics during the 90 days from Visit
- •Participant with a malignant disease or any concomitant end-state organ disease and/or laboratory abnormalities considered by Investigators to be risky or that could interfere with data collection.
- •Participants who have started receiving cognitive behavioural therapy (CBT) or psychotherapy in the last 90 days prior to Visit 2 or plan to start during the period of the study.
- •Participant who is severely immunocompromised (HIV positive, transplant patient, on anti-rejection medications, on a systemic steroid treatment for >30 days, or chemotherapy or radiotherapy within the last year).
- •Significant psychiatric diagnosis (e.g., bipolar), as diagnosed by a healthcare professional, including major depressive disorder (e.g., clinical depression) and anxiety disorder.
- •Participants taking anti-depressants or herbal treatments for mood disorders or psychological conditions (e.g., valerian, St. John's Wort) within 90 days prior to Visit 2 or planning to start during the study period.
- •Participants who are on anxiolytics, antipsychotics, anticonvulsants, antidepressants, opioid pain relievers, hypnotics, and/or prescribed sleep medication within 30 days prior to screening (Visit 1).
- •Participants with a current history of drug (including illicit drug) and /or alcohol abuse at the time of enrolment.
- •Participants who consume any products containing Tetrahydrocannabinol (THC) and Cannabidiol (CBD) 30 days prior to screening (Visit 1).
- •Participants who are unwilling to only consume butter or margarine once per day for the duration of the study.
- •Participants with a fiber intake of >18g/day
- •Participants who are pregnant (determined by urine pregnancy test for all individuals of childbearing potential at screening, regardless of contraceptive use or relationship status), breastfeeding, or wish to become pregnant during the study.
- •Have an acute or chronic illness (e.g., heart disease, uncontrolled hypertension, uncontrolled hypercholesterolemia, inflammatory bowel disease, cancer, HIV) that, in the Investigators judgment, precludes involvement in the study.
- •Have had any other condition or are taking a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk, or confound the interpretation of the study results.
- •Change in prescribed medication, or major diet change in the 30 days prior to enrolment (Visit 2).
- •Has received treatment involving experimental drugs in the past 90 days and experimental supplements in the past 60 days at the discretion of the investigator.
- •Individuals who, in the opinion of the investigator, are considered to be poor clinical attendees or unlikely for any reason to be able to comply with the trial.
结局指标
主要结局
To evaluate the effect of eight weeks consumption of triglyceride supplement compared to Placebo on low mood in a population with self-reported mild to moderate symptoms (Hospital Anxiety and Depression Scale - Depression, HADS-D score of 8 - 14).
时间窗: From baseline to Week 8
A change in self-reported symptoms of low mood assessed by Hospital Anxiety and Depression Scale - Depression (HADS-D) at baseline to week 8. HADS-D sub-score ranges from 0 - 21, where higher score is worse.
次要结局
- To evaluate the effect of consumption of triglyceride supplement compared to Placebo in a population with self-reported low mood with mild to moderate symptoms on Stress(From baseline to weeks 4 and 8)
- To evaluate the effect of consumption of triglyceride supplement compared to Placebo in a population with self-reported low mood with mild to moderate symptoms on general health, physical functioning and energy(From baseline to weeks 2, 4 and 8 or weeks 4 and 8)
- To evaluate the effect of consumption of triglyceride supplement compared to Placebo on low mood, in a population with self-reported mild to moderate symptoms (Hospital Anxiety and Depression Scale - Depression (HADS-D) score of 8 - 14).(From baseline to week 2 and week 4)
- To evaluate the effect of consumption of triglyceride supplement compared to Placebo in a population with self-reported low mood with mild to moderate symptoms on anxiety.(From baseline to weeks 2, 4 and 8)
- To evaluate the effect of consumption of triglyceride supplement compared to Placebo in a population with self-reported low mood with mild to moderate symptoms on sleep using Motionlogger Micro Watch (Sleep Watch) and Karolinska Sleepiness Scale (KSS).(From baseline to weeks 2, 4 and 8)
- To evaluate the effect of consumption of triglyceride supplement compared to Placebo in a population with self-reported low mood with mild to moderate symptoms on salivary cortisol(From baseline to weeks 2, 4 and 8)