Whole Coffee Fruit Concentrate Pilot Study 1

Completed · Not applicable

Conditions studied: Brain-derived Neurotrophic Factor (BDNF), Cognitive Function, Affect

In brief

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.

Key facts

Study ID

NCT01965795

Run by

University of California, Los Angeles

People needed

39

Starts

2013-10-01

Expected to finish

2014-12-01

Last updated by the study team

2015-01-19

Who can join

Age: 40 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• UCLA Semel Institute — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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