Effects of cogniVida™ on Learning and Memory and in Comparison to Placebo After Long-term Supplementation

NCT ID: NCT01647919

Last Updated: 2013-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2013-05-31

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.

Conditions

Healthy

Keywords

Cognition; Attention; Memory; Mood

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: TRIPLE

Study Groups

cogniVida™ 100 mg/day

Group Type: EXPERIMENTAL

cogniVida™ 100 mg/day

Intervention Type: DIETARY_SUPPLEMENT

4 capsules 25 mg (total 100 mg) cogniVida™ once a day

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

4 capsules of placebo identical to cogniVida™ once a day

Interventions

cogniVida™ 100 mg/day

4 capsules 25 mg (total 100 mg) cogniVida™ once a day

Intervention Type: DIETARY_SUPPLEMENT

Placebo

4 capsules of placebo identical to cogniVida™ once a day

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

DSM Nutritional Products, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Kennedy, Prof

Role: PRINCIPAL_INVESTIGATOR

Director of the 'Brain, Performance and Nutrition Research Centre', Northumbria University, UK

Crystal Haskell, PhD

Role: PRINCIPAL_INVESTIGATOR

Associate Director of the 'Brain, Performance and Nutrition Research Centre', Northumbria University, UK

Locations

Northumbria University

Newcastle upon Tyne, , United Kingdom

Countries

United Kingdom

Other Identifiers

2012-01-10-STEV

Identifier Type: -

Identifier Source: org_study_id