Clinical trial NCT01647919: Effects of cogniVida™ on Learning and Memory and in Comparison to Placebo After Long-term Supplementation
Official title: Effects of cogniVida™ on Learning and Memory and in Comparison to Placebo After Long-term Supplementation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy
Keywords: Cognition
Attention
Memory
Mood
Lead sponsor: DSM Nutritional Products, Inc.
Sponsor class: INDUSTRY
First posted: 2012-07-24
Enrollment: 88
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of the study is to examine the efficacy of cogniVida™ on learning and memory performance (executive function, associative, spatial and verbal memory) as well as on mood and attention parameters after four, eight and eleven weeks of supplementation and in comparison with placebo.

cogniVida™ is considered a dietary supplement, and therefore it is not an approved drug by the Food and Drug Administration (FDA). It is regulated like a food. The U.S. Food and Drug Administration does not strictly regulate herbs and dietary supplements. The investigators do not claim that this supplement is meant to treat any ailment.


Eligibility criteria: Inclusion Criteria:

* Males or Females, age 50 - 65 years
* Subject agrees to maintain his or her habitual diet and physical activity patterns throughout the study period.
* Subject has no health conditions that would prevent him/her from fulfilling the study requirements as judged by the Investigator on the basis of medical history and routine laboratory test results.
* Subject has a body mass index (BMI) of ≥18.5 and ≤ 30.00 kg/m2 at screening.
* Subject is willing to refrain from consuming alcoholic drinks 24 h prior to test days and until the end of each assessment period and refrain from consuming caffeine, and caffeine-containing products 12 h prior to test days and until the end of each assessment period.
* Subject is willing to refrain from vigorous physical activity 12 h prior to test days.
* Subject understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.

Exclusion Criteria:

* Subject has a positive drug screening of amphetamines, barbiturates, benzodiazepines, cannabis, cocaine, methamphetamines, methadone, 3,4-methylenedioxymethamphetamine, opiates or tricyclic antidepressants at screening or at any of the admission days.
* Subjects has a positive breath alcohol and breath carbon monoxide test at screening or at any of the admission days.
* Subject has abnormal clinical chemistry and hematology laboratory test results of clinical significance according to established criteria.
* Subjects with a history of renal or hepatic disease that is likely to interfere with the metabolism or excretion of the test product.
* Subject has donated more than 300 mL of blood during the three months prior to screening.
* Subject has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg) as defined by the average blood pressure measured at screening.
* Subject has a history, in the judgment of the Investigator, of a psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study.
* Excessive habitual caffeine consumption (\>500 mg caffeine/d), following screening and throughout the study period. Caffeine consumption will be assessed using the Caffeine Consumption Questionnaire
* Subjects who are on a significant hypocaloric diet (i.e. \< 1200 calories per day) aiming for significant weight loss.
* Use of any sleep aid medication within four days prior to each test day (visits 2, 3, 4, 5; days 0, 28, 56, 77).
* Subject has a history or presence of cancer in the prior two years, except for non-melanoma skin cancer.
* Subject is pregnant, planning to be pregnant during the study period, lactating, or women who consider themselves to be of childbearing potential and who are engaged in an active sex life who are unwilling to commit to the use of an approved form of contraception throughout the study period. The method of contraception must be recorded in the source documentation.
* Use of any psychotropic medication within four weeks of visit 1, day -14 and throughout the study.
* Use of dietary supplements containing any of the following: lutein, ginkgo biloba, St. John's wort, ginseng, gotu kola (Indian pennywort); daily doses of vitamin E (≥30 mg/d) or folic acid (≥400 ug/d); thiamine, riboflavin, and/or pyridoxine (≥2 mg/d); and eicosapentaenoic acid (EPA), docosahexaenoic acid or a combination of EPA + DHA (≥500 mg/d) within 2 weeks prior to screening.
* Subject has had exposure to any non-registered drug product within 30 days prior to the screening visit and throughout the study.
* Recent history of (within 12 months of screening visit) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as \>60g (men) / 40g (women) pure alcohol per day (7 / 5.5 units).
* Subject has a known allergy or sensitivity to study product or any ingredients of the study product or meals provided.
* The subject is unable to perform the tests on the COMPASS System during training to the established acceptable levels for participation in this type of study.
* Use of stevia extract sweetened products/drinks or stevia leaves within 1 month of the study

Primary outcomes:
measure: Associative / Visual Memory (Name to Face Recall (COMPASS))
timeFrame: Day 0 (baseline) to day 28
measure: Associative / Visual Memory (Name to Face Recall (COMPASS))
timeFrame: Day 0 (baseline) to day 56
measure: Associative / Visual Memory (Name to Face Recall (COMPASS))
timeFrame: Day 0 (baseline) to day 77
measure: Visual Memory (Picture Recognition (COMPASS))
timeFrame: Day 0 (baseline) to day 28
measure: Visual Memory (Picture Recognition (COMPASS))
timeFrame: Day 0 (baseline) to day 56
measure: Visual Memory (Picture Recognition (COMPASS))
timeFrame: Day 0 (baseline) to day 77
measure: Working and Spatial Memory ('Sternberg' Numeric Working Memory task (COMPASS))
timeFrame: Day 0 (baseline) to day 28
measure: Working and Spatial Memory ('Sternberg' Numeric Working Memory task (COMPASS))
timeFrame: Day 0 (baseline) to day 56
measure: Working and Spatial Memory ('Sternberg' Numeric Working Memory task (COMPASS))
timeFrame: Day 0 (baseline) to day 77
measure: Working and Spatial Memory ('Corsi Blocks'(COMPASS))
timeFrame: Day 0 (baseline) to day 28
measure: Working and Spatial Memory ('Corsi Blocks'(COMPASS))
timeFrame: Day 0 (baseline) to day 56
measure: Working and Spatial Memory ('Corsi Blocks'(COMPASS))
timeFrame: Day 0 (baseline) to day 77
measure: Executive Function and Verbal Memory (Peg and Ball Task (COMPASS))
timeFrame: Day 0 (baseline) to day 28
measure: Executive Function and Verbal Memory (Peg and Ball Task (COMPASS))
timeFrame: Day 0 (baseline) to day 56
measure: Executive Function and Verbal Memory (Peg and Ball Task (COMPASS))
timeFrame: Day 0 (baseline) to day 77
measure: Executive Function and Verbal Memory (Delayed Word Recognition (COMPASS))
timeFrame: Day 0 (baseline) to day 28
measure: Executive Function and Verbal Memory (Delayed Word Recognition (COMPASS))
timeFrame: Day 0 (baseline) to day 56
measure: Executive Function and Verbal Memory (Delayed Word Recognition (COMPASS))
timeFrame: Day 0 (baseline) to day 77
Secondary outcomes:
measure: Attention and Concentration (Choice Reaction Time (COMPASS))
timeFrame: Day 0 (baseline) to day 28
measure: Attention and Concentration (Choice Reaction Time (COMPASS))
timeFrame: Day 0 (baseline) to day 56
measure: Attention and Concentration (Choice Reaction Time (COMPASS))
timeFrame: Day 0 (baseline) to day 77
measure: Attention and Concentration (Rapid Visual Information Processing (COMPASS))
timeFrame: Day 0 (baseline) to day 28
measure: Attention and Concentration (Rapid Visual Information Processing (COMPASS))
timeFrame: Day 0 (baseline) to day 56
measure: Attention and Concentration (Rapid Visual Information Processing (COMPASS))
timeFrame: Day 0 (baseline) to day 77
measure: Bond-Lader Visual Analog Scales (VAS) of Mood
timeFrame: Day 0 (baseline) to day 28
measure: Bond-Lader Visual Analog Scales (VAS) of Mood
timeFrame: Day 0 (baseline) to day 56
measure: Bond-Lader Visual Analog Scales (VAS) of Mood
timeFrame: Day 0 (baseline) to day 77
measure: Profile of Mood States (POMS) Questionnaire
timeFrame: Day 0 (baseline) to day 28
measure: Profile of Mood States (POMS) Questionnaire
timeFrame: Day 0 (baseline) to day 56
measure: Profile of Mood States (POMS) Questionnaire
timeFrame: Day 0 (baseline) to day 77
measure: Prospective and Retrospective Memory Questionnaire (PRMQ)
timeFrame: Day 0 (baseline) to day 28
measure: Prospective and Retrospective Memory Questionnaire (PRMQ)
timeFrame: Day 0 (baseline) to day 56
measure: Prospective and Retrospective Memory Questionnaire (PRMQ)
timeFrame: Day 0 (baseline) to day 77
Other outcomes:
Locations:
city: Newcastle upon Tyne
country: United Kingdom
facility: Northumbria University
Study officials:
affiliation: Director of the 'Brain, Performance and Nutrition Research Centre', Northumbria University, UK
name: David Kennedy, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate Director of the 'Brain, Performance and Nutrition Research Centre', Northumbria University, UK
name: Crystal Haskell, PhD
role: PRINCIPAL_INVESTIGATOR
References: