Whole Coffee Fruit Concentrate Pilot Study 1
Public ClinicalTrials.gov record NCT01965795. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Effects of Whole Coffee Fruit Concentrate On Cognition and Mood In Healthy Adults: A Pilot Clinical Study
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01965795
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 39 participants
Conditions and interventions
Interventions
- Whole Coffee Fruit Concentrate (WCFC) Dietary Supplement
- Nutrim Dietary Supplement
Dietary Supplement
Eligibility (public fields only)
- Age range
- 40 Years to 55 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2013
- Primary completion
- Nov 30, 2014
- Completion
- Nov 30, 2014
- Last update posted
- Jan 18, 2015
2013 – 2014
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCLA Semel Institute | Los Angeles | California | 90095 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01965795, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 18, 2015 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01965795 live on ClinicalTrials.gov.