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NCT01965795 · ClinicalTrials.gov registry record · NA
Whole Coffee Fruit Concentrate Pilot Study 1
A NA study, sponsored by University of California, Los Angeles.
- Completed
- Registry status
- NA
- Development phase
- 39
- Enrollment target
NCT01965795 is a NA study that has completed, run by University of California, Los Angeles. The registered enrollment target is 39 participants.
The verdict
NCT01965795, a NA study, has completed, sponsored by University of California, Los Angeles.
- COMPLETED
- Registry status
- NA
- Development phase
- 39 participants
- Enrollment target
Study Summary
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
Interventions
- DIETARY_SUPPLEMENT Whole Coffee Fruit Concentrate (WCFC)
- DIETARY_SUPPLEMENT Nutrim
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2013-10 |
| Est. Completion | 2014-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01965795
The ClinicalTrials.gov registry entry for NCT01965795 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Los Angeles, which has 897 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Whole Coffee Fruit Concentrate (WCFC) is the first listed.
NCT01965795 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01965795 about?
NCT01965795 is a clinical study titled "Whole Coffee Fruit Concentrate Pilot Study 1". 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-adminis...
What is the current status of trial NCT01965795?
This trial is currently completed. It is a NA study. The enrollment target is 39 participants. The study started on 2013-10. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01965795?
The interventions under investigation include: Whole Coffee Fruit Concentrate (WCFC) (DIETARY_SUPPLEMENT), Nutrim (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01965795?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
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