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Trial record 16 of 77 for:    coffee

Whole Coffee Fruit Concentrate Pilot Study 1 (WCFC)

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ClinicalTrials.gov Identifier: NCT01965795
Recruitment Status : Completed
First Posted : October 18, 2013
Last Update Posted : January 19, 2015
Sponsor:
Collaborator:
Applied BioClinical Inc.
Information provided by (Responsible Party):
Edythe London, University of California, Los Angeles

Brief 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 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.


Condition or disease Intervention/treatment Phase
Brain-derived Neurotrophic Factor (BDNF) Cognitive Function Affect Dietary Supplement: Whole Coffee Fruit Concentrate (WCFC) Dietary Supplement: Nutrim Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Effects of Whole Coffee Fruit Concentrate On Cognition and Mood In Healthy Adults: A Pilot Clinical Study
Study Start Date : October 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Arm Intervention/treatment
Placebo Comparator: Nutrim

Nutrim will be capsulated in size 1 gelatin capsules, white and blue, distributed in brown plastic bottles (28 caps/bottle: enough for 14 days of treatment). The first bottle will be provided at the time of randomization, and the second bottle will be provided on day 14 for dosing on days 15-28. The bottle will be labeled with the ABC logo and treatment code.

A dose of 100 mg will be administered twice daily (once before breakfast and again before dinner).

Dietary Supplement: Nutrim
Nutrim is an oat bran powder Nutrim is hypothesized to bestow a number of benefits such as cardiovascular health, glucose management and healthy digestion. However, improved cognition is not one of the hypothesized benefits. This product is free of caffeine and stimulants.

Experimental: Whole Coffee Fruit Concentrate (WCFC)

WCFC is in powder form, and will be capsulated in size 1 gelatin capsules, white and blue, distributed in brown plastic bottles (28 caps/bottle: enough for 14 days of treatment). The first bottle will be provided at the time of randomization, and the second bottle will be provided on day 14 for dosing on days 15-28. The bottles will be labeled with the ABC logo and treatment code.

A dose of 100 mg will be administered twice daily (once before breakfast and again before dinner).

Dietary Supplement: Whole Coffee Fruit Concentrate (WCFC)
Neurfactor is a powder dietary supplement patented by Futureceuticals, in which the active ingredient is WCFC. It is hypothesized that the whole fruit of the coffee plant, Coffea arabica, has very unique, important benefits for healthy aging not available from regular coffee, other coffee extracts, green coffee bean extracts, caffeine, or other leading botanicals. NeuroFactor is thought to increase Brain‐Derived Neurotrophic Factor, a protein vital for neuron development, repair and protection and essential for learning, memory, alertness, controlling body weight, and energy metabolism.
Other Name: NeuroFactor




Primary Outcome Measures :
  1. Biochemical measures of brain-derived neurotrophic factor (BDNF) [ Time Frame: 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.


Secondary Outcome Measures :
  1. Cognitive Functioning [ Time Frame: 28 days ]

    Tests of cognitive function will be given on day 0, 14, and 28.

    Tests include:

    • Hopkins Verbal Learning Test- Revised (HVLT-R): assessment of verbal memory.
    • Continuous Performance Test (CPT): assessment of attention & inhibition.
    • Spatial Sternberg: assessment of spatial short term memory.
    • Letter Number Sequencing: assessment of working memory.
    • Attention Networks Task: assessment of attention & inhibition.
    • Verbal fluency: assessment of executive function.
    • Finger Tapping: assessment of psychomotor speed.


Other Outcome Measures:
  1. Affect [ Time Frame: 28 days ]

    The following mood assessments will be given on days 0, 14, & 28:

    • HAM-D. The Hamilton Depression Rating Scale is a multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. The questionnaire is designed for adults and is used to rate the severity of their depression by probing mood, feelings of guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. Assessment time is estimated at 20 minutes.
    • PANAS. The Positive and Negative Affect Schedule (Watson et al., 1988) is a 20-item questionnaire that comprises two mood scales, one measuring positive affect and the other measuring negative affect.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01965795


Locations
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United States, California
UCLA Semel Institute
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Applied BioClinical Inc.
Investigators
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Principal Investigator: Edythe D London, PhD Professor in Residence

Publications:

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Responsible Party: Edythe London, Ph.D., University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01965795     History of Changes
Other Study ID Numbers: 13-001426
First Posted: October 18, 2013    Key Record Dates
Last Update Posted: January 19, 2015
Last Verified: January 2015

Keywords provided by Edythe London, University of California, Los Angeles:
Brain-derived neurotrophic factor
Cognitive function
Dietary supplement
Coffee plant extract