Ignite Creation Date:
2024-05-06 @ 2:04 AM
Last Modification Date:
2024-10-26 @ 11:13 AM
Study NCT ID:
NCT01965795
Status:
COMPLETED
Last Update Posted:
2015-01-19
First Post:
2013-10-16
Brief Title:
Whole Coffee Fruit Concentrate Pilot Study 1
Sponsor:
University of California Los Angeles
Organization:
University of California Los Angeles
Study Overview
Official Title:
Effects of Whole Coffee Fruit Concentrate On Cognition and Mood In Healthy Adults A Pilot Clinical Study
Status:
COMPLETED
Status Verified Date:
2015-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WCFC
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 Londons 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
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 Londons 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
Detailed Description:
Participants n23 20 completing with usable data will come to UCLA for 1 in-person screening visit and 4 weekly study visits culminating in a total of 5 study visits Those who meet eligibility criteria will take part in a baseline test session before randomization to collect cognitive and behavioral data as well as baseline plasma BDNF level There will also be two test sessions at 14 and 28 days of treatment to collect data on the effects of the active and placebo treatments The questionnaires cognitive tasks and diagnostic interviews will be conducted on an outpatient basis at the Semel Institute for Neuroscience and Human Behavior and the medical procedures will take place at the UCLA Clinical and Translational Research Center CTRC
In-person screening procedures
First investigators will thoroughly explain the study and obtain informed consent from interested participants Immediately after consent is obtained the following questionnaires diagnostic interviews will be completed
Study Admission Intake Form- This questionnaire administered at intake collects demographic information ie ethnicity education employment general and mental health history as well as substance abuse history This questionnaire takes approximately 15-45 min to complete
Psychiatric evaluation using the SCID-IR-TR The SCID will be administered during intake screening to determine whether the participant meets the DSM-IV-TR criteria for drug dependence and to rule out any major psychiatric disorders eg affective disorders schizophrenia Spitzer et al 1995
The International Physical Activity Questionnaires IPAQ The purpose of the IPAQ Craig et al 2003 is to record any exercise that participants engage in as this may impact findings It takes approximately 5 min to complete
Urine testing 40 ml will be done to test for pregnancy females only and drugs of abuse Urine testing will be done at screening as well as each of the study visits Once the urine has been analyzed it will be disposed of in a sanitary manner
Medical Procedures completed during in-person screening
Participants will give a blood sample taken for Rapid Plasma Reagin RPR and Hepatitis B and C testing 25-ml sample to including a complete chemistry panel 5 ml hepatic panel 3 ml Hepatitis B and C RPR test 7 ml plasma BDNF 01 ml The study physician will inform participants of the implications if their status for RPR hepatitis B or hepatitis C test results is positive and will refer participants to further information Study staff will inform participants with negative RPR hepatitis B and hepatitis C test results of their health status Height and weight will be assessed as body mass index BMI values provide inclusion criteria 18 BMI 25 kgm2 In addition vital signs such as heart-rate ECG pulse and blood pressure will be measured Plasma BDNF and other biomarkers will be measured by a blood sample finger stick obtained prior to and at each weekly visit to UCLA after initiating WCFC or placebo administration
The maximum time period allowable between the screening visits and attendance at the UCLA CTRC will be 4 weeks If this time elapses the potential subject will be screened again
Study Visit Timeline
Day Up to -28 Telephone screening Day 0- In-person medical screening baseline cognitive testing session and rating of subjective mood states BDNF assay Randomization to group and initiation of WCFCplacebo treatment with 14-day supply provided to the participant
Day 7- Collection of compliance questionnaire BDNF assay Day 14- Cognitive testing and rating of subjective mood states Collection of compliance questionnaire re-supply WCFCplacebo and phlebotomy for blood chemistry and assay of BDNF and other biomarkers
Day 21- Collection of compliance questionnaire BDNF assay Day 28- Completion of WCFCplacebo treatment Final cognitive testing session and rating of subjective mood states Collection of compliance questionnaire Phlebotomy for blood chemistry and assay of BDNF and other biomarkers
Study Visit Procedures 2-3 hrs
Participants meeting the inclusion criteria will 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 On day 0 at baseline and day 14 WCFC or placebo will be provided in amounts sufficient for a 2-week supply so that they can self-administer the respective treatments 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
Nutraceutical Administration and Dose Justification
WCFC NeurofactorTM A dose of 100 mg will be administered twice daily once before breakfast and again before dinner The dose was chosen on the basis of published work from Applied Bioclinical Inc Reyes-Izquierdo et al 2013 Pietrzkowski et al in press Specifically Reyes-Izquierdo and colleagues 2013 reported that 100 mg of WCFC resulted in increased plasma BDNF by 143 from baseline n10 healthy adults aged between 18 and 55 years old More recently Pietrzkowski and co-workers unpublished manuscript in press observed a 90 increase in plasma BDNF during the first 60 minutes after a single 100 mg dose of WCFC The effect is sustained for 2-3 hours Therefore testing will always take place in the morning within 2 hours of WCFC ingestion with breakfast As a quality control measure WCFC batches will be tested to delineate the same chemical profile of polyphenols to make sure that if more than one batch is used the chemical profiles are identical between batches
Placebo The placebo will be Nutrim supplied by Abclinical and administered twice daily identical to WCFC treatment other participant group
Both WCFC and placebo are in powder form and will be capsulated in size 1 gelatin capsules white and blue distributed in brown plastic bottles 28 capsbottle 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 ABC7UCLA01 and ABC7UCLA12
The following questionnaires that assess mood will be administered during each of the study sessions
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 The HAM-D has been used previously showing a correlation between increased plasma BDNF and improved decreased HAM-D scores eg Shimizu et al 2003 Gonul et al 2005 Aydemir et al 2005 Yoshimura et al 2007
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 Each item is rated on a 5-point scale ranging from 1 very slightly or not at all to 5 extremely to indicate the extent to which the respondent has felt this way in the indicated time frame The participant will be instructed to provide these ratings of his or her affective state at the time of assessment
Adverse Events Log- At each visit after randomization any adverse events that occur will be recorded and evaluated in terms of frequency and severity mild moderate severe using this form
The following cognitive tests will be administered during each of the study sessions
Hopkins Verbal Learning Test- Revised HVLT-R This task is an assessment of verbal memory
Continuous Performance Test CPT This computer task is an assessment of attention inhibition
Spatial Sternberg This computer task is an assessment of spatial short term memory
Letter Number Sequencing This task in an assessment of working memory
Attention Networks Task This computer task is an assessment of attention inhibition
Verbal fluency This task is an assessment of executive function
Finger Tapping This task is an assessment of psychomotor speed
These tests will assess multiple cognitive domains and the total battery of tests will take approximately 15 hours to complete Thus the burden on participants will be low Participants will be trained on the tasks before the baseline measurement is taken to reduce the effects of learning on performance
Biochemical Measures
The biochemical measurements that will be performed during the study will be the determination of plasma BDNF at baseline conducted during medical screening procedure and at each weekly visit following the initiation of WCFC and placebo administration and assay of other biomarkers in serum at the 14- and 28-day test points Determination of plasma BDNF must be performed at the same time of day for all subjects at all time-points due to diurnal variation in plasma BDNF levels Piccini et al 2008 Weekly BDNF data will be used as an index of compliance with WCFC administration Data at baseline 14 days and 28 days will be used in tests of association with behavioral measures
In-person screening procedures
First investigators will thoroughly explain the study and obtain informed consent from interested participants Immediately after consent is obtained the following questionnaires diagnostic interviews will be completed
Study Admission Intake Form- This questionnaire administered at intake collects demographic information ie ethnicity education employment general and mental health history as well as substance abuse history This questionnaire takes approximately 15-45 min to complete
Psychiatric evaluation using the SCID-IR-TR The SCID will be administered during intake screening to determine whether the participant meets the DSM-IV-TR criteria for drug dependence and to rule out any major psychiatric disorders eg affective disorders schizophrenia Spitzer et al 1995
The International Physical Activity Questionnaires IPAQ The purpose of the IPAQ Craig et al 2003 is to record any exercise that participants engage in as this may impact findings It takes approximately 5 min to complete
Urine testing 40 ml will be done to test for pregnancy females only and drugs of abuse Urine testing will be done at screening as well as each of the study visits Once the urine has been analyzed it will be disposed of in a sanitary manner
Medical Procedures completed during in-person screening
Participants will give a blood sample taken for Rapid Plasma Reagin RPR and Hepatitis B and C testing 25-ml sample to including a complete chemistry panel 5 ml hepatic panel 3 ml Hepatitis B and C RPR test 7 ml plasma BDNF 01 ml The study physician will inform participants of the implications if their status for RPR hepatitis B or hepatitis C test results is positive and will refer participants to further information Study staff will inform participants with negative RPR hepatitis B and hepatitis C test results of their health status Height and weight will be assessed as body mass index BMI values provide inclusion criteria 18 BMI 25 kgm2 In addition vital signs such as heart-rate ECG pulse and blood pressure will be measured Plasma BDNF and other biomarkers will be measured by a blood sample finger stick obtained prior to and at each weekly visit to UCLA after initiating WCFC or placebo administration
The maximum time period allowable between the screening visits and attendance at the UCLA CTRC will be 4 weeks If this time elapses the potential subject will be screened again
Study Visit Timeline
Day Up to -28 Telephone screening Day 0- In-person medical screening baseline cognitive testing session and rating of subjective mood states BDNF assay Randomization to group and initiation of WCFCplacebo treatment with 14-day supply provided to the participant
Day 7- Collection of compliance questionnaire BDNF assay Day 14- Cognitive testing and rating of subjective mood states Collection of compliance questionnaire re-supply WCFCplacebo and phlebotomy for blood chemistry and assay of BDNF and other biomarkers
Day 21- Collection of compliance questionnaire BDNF assay Day 28- Completion of WCFCplacebo treatment Final cognitive testing session and rating of subjective mood states Collection of compliance questionnaire Phlebotomy for blood chemistry and assay of BDNF and other biomarkers
Study Visit Procedures 2-3 hrs
Participants meeting the inclusion criteria will 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 On day 0 at baseline and day 14 WCFC or placebo will be provided in amounts sufficient for a 2-week supply so that they can self-administer the respective treatments 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
Nutraceutical Administration and Dose Justification
WCFC NeurofactorTM A dose of 100 mg will be administered twice daily once before breakfast and again before dinner The dose was chosen on the basis of published work from Applied Bioclinical Inc Reyes-Izquierdo et al 2013 Pietrzkowski et al in press Specifically Reyes-Izquierdo and colleagues 2013 reported that 100 mg of WCFC resulted in increased plasma BDNF by 143 from baseline n10 healthy adults aged between 18 and 55 years old More recently Pietrzkowski and co-workers unpublished manuscript in press observed a 90 increase in plasma BDNF during the first 60 minutes after a single 100 mg dose of WCFC The effect is sustained for 2-3 hours Therefore testing will always take place in the morning within 2 hours of WCFC ingestion with breakfast As a quality control measure WCFC batches will be tested to delineate the same chemical profile of polyphenols to make sure that if more than one batch is used the chemical profiles are identical between batches
Placebo The placebo will be Nutrim supplied by Abclinical and administered twice daily identical to WCFC treatment other participant group
Both WCFC and placebo are in powder form and will be capsulated in size 1 gelatin capsules white and blue distributed in brown plastic bottles 28 capsbottle 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 ABC7UCLA01 and ABC7UCLA12
The following questionnaires that assess mood will be administered during each of the study sessions
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 The HAM-D has been used previously showing a correlation between increased plasma BDNF and improved decreased HAM-D scores eg Shimizu et al 2003 Gonul et al 2005 Aydemir et al 2005 Yoshimura et al 2007
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 Each item is rated on a 5-point scale ranging from 1 very slightly or not at all to 5 extremely to indicate the extent to which the respondent has felt this way in the indicated time frame The participant will be instructed to provide these ratings of his or her affective state at the time of assessment
Adverse Events Log- At each visit after randomization any adverse events that occur will be recorded and evaluated in terms of frequency and severity mild moderate severe using this form
The following cognitive tests will be administered during each of the study sessions
Hopkins Verbal Learning Test- Revised HVLT-R This task is an assessment of verbal memory
Continuous Performance Test CPT This computer task is an assessment of attention inhibition
Spatial Sternberg This computer task is an assessment of spatial short term memory
Letter Number Sequencing This task in an assessment of working memory
Attention Networks Task This computer task is an assessment of attention inhibition
Verbal fluency This task is an assessment of executive function
Finger Tapping This task is an assessment of psychomotor speed
These tests will assess multiple cognitive domains and the total battery of tests will take approximately 15 hours to complete Thus the burden on participants will be low Participants will be trained on the tasks before the baseline measurement is taken to reduce the effects of learning on performance
Biochemical Measures
The biochemical measurements that will be performed during the study will be the determination of plasma BDNF at baseline conducted during medical screening procedure and at each weekly visit following the initiation of WCFC and placebo administration and assay of other biomarkers in serum at the 14- and 28-day test points Determination of plasma BDNF must be performed at the same time of day for all subjects at all time-points due to diurnal variation in plasma BDNF levels Piccini et al 2008 Weekly BDNF data will be used as an index of compliance with WCFC administration Data at baseline 14 days and 28 days will be used in tests of association with behavioral measures
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None