Whole Coffee Fruit Concentrate Pilot Study 1

NCT01965795 | Completed

• 1 other identifier: 13-001426
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain-derived Neurotrophic Factor (BDNF); Cognitive Function; Affect

Keywords

Brain-derived neurotrophic factor; Cognitive function; Dietary supplement; Coffee plant extract

Outcome Measures

Primary Outcomes (1)

• Biochemical measures of brain-derived neurotrophic factor (BDNF)

  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.

  28 days

Secondary Outcomes (1)

• Cognitive Functioning

  28 days

Other Outcomes (1)

• Affect

  28 days

Study Arms (2)

Nutrim

PLACEBO COMPARATOR

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

Whole Coffee Fruit Concentrate (WCFC)

EXPERIMENTAL

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)

Interventions

Whole Coffee Fruit Concentrate (WCFC) DIETARY_SUPPLEMENT

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.

Also known as: NeuroFactor

Whole Coffee Fruit Concentrate (WCFC)

Nutrim DIETARY_SUPPLEMENT

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.

Nutrim

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Applied BioClinical Inc.: collaborator

Study Sites (1)

UCLA Semel Institute

Los Angeles, California, 90095, United States

Location

Related Publications (6)

• Reyes-Izquierdo T, Nemzer B, Shu C, Huynh L, Argumedo R, Keller R, Pietrzkowski Z. Modulatory effect of coffee fruit extract on plasma levels of brain-derived neurotrophic factor in healthy subjects. Br J Nutr. 2013 Aug 28;110(3):420-5. doi: 10.1017/S0007114512005338. Epub 2013 Jan 14.

  PMID: 23312069 BACKGROUND

• Yoshimura R, Mitoma M, Sugita A, Hori H, Okamoto T, Umene W, Ueda N, Nakamura J. Effects of paroxetine or milnacipran on serum brain-derived neurotrophic factor in depressed patients. Prog Neuropsychopharmacol Biol Psychiatry. 2007 Jun 30;31(5):1034-7. doi: 10.1016/j.pnpbp.2007.03.001. Epub 2007 Mar 7.

  PMID: 17459550 BACKGROUND

• Gonul AS, Akdeniz F, Taneli F, Donat O, Eker C, Vahip S. Effect of treatment on serum brain-derived neurotrophic factor levels in depressed patients. Eur Arch Psychiatry Clin Neurosci. 2005 Dec;255(6):381-6. doi: 10.1007/s00406-005-0578-6. Epub 2005 Apr 6.

  PMID: 15809771 BACKGROUND

• Shimizu E, Hashimoto K, Okamura N, Koike K, Komatsu N, Kumakiri C, Nakazato M, Watanabe H, Shinoda N, Okada S, Iyo M. Alterations of serum levels of brain-derived neurotrophic factor (BDNF) in depressed patients with or without antidepressants. Biol Psychiatry. 2003 Jul 1;54(1):70-5. doi: 10.1016/s0006-3223(03)00181-1.

  PMID: 12842310 BACKGROUND

• Piccinni A, Marazziti D, Catena M, Domenici L, Del Debbio A, Bianchi C, Mannari C, Martini C, Da Pozzo E, Schiavi E, Mariotti A, Roncaglia I, Palla A, Consoli G, Giovannini L, Massimetti G, Dell'Osso L. Plasma and serum brain-derived neurotrophic factor (BDNF) in depressed patients during 1 year of antidepressant treatments. J Affect Disord. 2008 Jan;105(1-3):279-83. doi: 10.1016/j.jad.2007.05.005. Epub 2007 Jun 5.

  PMID: 17553570 BACKGROUND

• Ogle WO, Speisman RB, Ormerod BK. Potential of treating age-related depression and cognitive decline with nutraceutical approaches: a mini-review. Gerontology. 2013;59(1):23-31. doi: 10.1159/000342208. Epub 2012 Aug 30.

  PMID: 22947921 BACKGROUND

Study Officials

• Edythe D London, PhD

  Professor in Residence

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D.

Study Record Dates

• First Submitted: October 16, 2013
• First Posted: October 18, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 19, 2015

Record last verified: 2015-01

Locations

US (1)