Effects of Whole Coffee Fruit Concentrate On Cognition and Mood In Healthy Adults: A Pilot Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Biochemical measures of brain-derived neurotrophic factor (BDNF)
研究概览
简要总结
The purpose of this pilot study is to evaluate the potential effects of whole coffee fruit concentrate (WCFC, Neurofactor), a product that elevates circulating brain-derived neurotrophic factor (BDNF), on cognition and mood in healthy adults.
The projected outcome of this study is that self-administration of Neurofactor for 28 days (or even 14 days) will be associated with an improvement in mood and scores on cognitive tests, and that the change will exceed that observed with administration of Nutrim (placebo).
Volunteers will be recruited from the greater Los Angeles community. Participants will be middle-aged nonsmokers, in good health, and between the ages of 40-55 to enhance the chance of demonstrating pro-cognitive effects. Younger participants, whose cognitive performance is expected to be higher, may perform at a ceiling level, with less room for improvement by the product under study.
Participants who call our lab will be told about the study in more detail, and will complete a 5 minute phone screener to determine preliminary eligibility. After the initial telephone screening, participants will visit Dr. London's laboratory at UCLA to provide written informed consent.
The first study visit will be an in-person screening visit to determine full eligibility. The evaluation will include a psychiatric diagnostic interview, using the SCID, blood tests, urine samples (to test for drug use and pregnancy). Participants will also be interviewed about their prior and current drug use, including tobacco use. In addition, participants will be interviewed about the nature of their employment and physical exercise habits: endurance training has been shown to increase plasma BDNF in young men.
Participants meeting the inclusion criteria will attend the Semel Institute for Neuroscience and Human Behavior at UCLA to take part in baseline measurements, and to be randomized to receive either WCFC or placebo. During the active treatment time (28 days), they will visit the UCLA Semel Institute on a weekly basis. At each of these weekly visits, questionnaires regarding compliance will be completed, and blood samples will be taken for assay of BDNF. A cognitive test battery and mood-rating scales will be completed at baseline and at 14 and 28 days of treatment. At the midpoint assessment (14 days) and at completion of treatment (28 days) blood will be drawn for assay of a blood chemistry panel (as at baseline) as well as for biomarkers in addition to BDNF.
详细描述
Participants (n=23; 20 completing with usable data) will come to UCLA for 1 in-person screening visit and 4 weekly study visits, culminating in a total of 5 study visits. Those who meet eligibility criteria will take part in a baseline test session (before randomization) to collect cognitive and behavioral data as well as baseline plasma BDNF level. There will also be two test sessions at 14 and 28 days of treatment to collect data on the effects of the active and placebo treatments. The questionnaires, cognitive tasks, and diagnostic interviews will be conducted on an outpatient basis at the Semel Institute for Neuroscience and Human Behavior, and the medical procedures will take place at the UCLA Clinical and Translational Research Center (CTRC).
In-person screening procedures:
First, investigators will thoroughly explain the study and obtain informed consent from interested participants. Immediately after consent is obtained, the following questionnaires/ diagnostic interviews will be completed:
- Study Admission & Intake Form- This questionnaire administered at intake collects demographic information (i.e. ethnicity, education, employment), general and mental health history, as well as substance abuse history. This questionnaire takes approximately 15-45 min to complete.
- Psychiatric evaluation using the SCID-IR-TR. The SCID will be administered during intake screening to determine whether the participant meets the DSM-IV-TR criteria for drug dependence and to rule out any major psychiatric disorders (e.g., affective disorders, schizophrenia; Spitzer et al., 1995).
- The International Physical Activity Questionnaires (IPAQ). The purpose of the IPAQ (Craig et al., 2003) is to record any exercise that participants engage in as this may impact findings. It takes approximately 5 min to complete.
Urine testing (40 ml) will be done to test for pregnancy (females only) and drugs of abuse. Urine testing will be done at screening as well as each of the study visits. Once the urine has been analyzed, it will be disposed of in a sanitary manner.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: Participants must be 45-55 years old. Investigators have selected an age range of 40-55 years to enhance the chance of demonstrating pro-cognitive effects. Younger participants, whose cognitive performance is expected to be higher, may perform at a ceiling level, with less room for improvement by the product under study. An emerging body of data suggests speculation that natural polyphenols can combat age-related cognitive decline, which is often accompanied by depression and potentially by reduced levels of hippocampal neurogenesis (Ogle et al., 2013).
- •Language: Subjects must be fluent in English (in order to provide consent, complete questionnaires,& cognitive testing)
- •BMI: Body mass index values ≥ 18 kg/m2 and ≤ 25 kg/m2
- •Vital signs: must be within the clinically acceptable normal range (i.e., resting pulse between 50 and 90 beats/min (bpm), blood pressures between 85-150 mm Hg systolic and 45-90 mm Hg diastolic
- •Pregnancy prevention: if female, must either be unable to conceive (i.e., surgically sterilized, sterile, or post-menopausal,) or agree to use a reliable form of contraception (e.g., birth control pills, intrauterine device, condoms, or spermicide) during the trial and to provide a negative pregnancy urine test before randomization.
排除标准
- •Certain medical conditions: Participants may not have a medical condition that, in the study physician's judgment, may interfere with safe participation (e.g., active tuberculosis, unstable cardiac, renal, pulmonary or liver disease, unstable diabetes)
- •Neurological disorder: Participants should not have a current neurological disorder (e.g., organic brain disease, dementia) or a medical history which would make compliance difficult or would compromise informed consent
- •Psychiatric disorder: must not have an Axis I psychiatric disorder as assessed by the Structured Clinical Inventory for DSM-IV-TR (SCID)
- •Suicide Attempt(s): Participants may not have a history of attempted suicide in the past 3 years and/or serious suicidal intention or plan in the past month as assessed by the SCID
- •Prescription medications: must not be taking a prescription medication that can affect brain function
- •Alcohol dependence: Must not have a history of alcohol dependence within the past 3 years
- •Pregnancy or nursing
- •Heart abnormality: Participants should not have a clinically significant heart disease or hypertension; ECG showing cardiac ischemia or other clinically significant abnormality
- •Smoking: Participants must be current non-smokers
- •Illicit drug use: Participants must not have a current dependence on cocaine, opiates, alcohol, or benzodiazepines as defined by DSM-IV-TR
- •Other: Participants may not have any other circumstance that, in the opinion of investigators, would compromise safety
结局指标
主要结局
Biochemical measures of brain-derived neurotrophic factor (BDNF)
时间窗: 28 days
One of the outcome measures will be the determination of plasma BDNF at 3 different time points within a 28 day period via a blood sample.
次要结局
- Cognitive Functioning(28 days)
研究者
Edythe London
Ph.D.
University of California, Los Angeles