Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
211 participants
INTERVENTIONAL
2015-12-31
2020-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Cerebrovascular and Cognitive Improvement by Resveratrol (resVida) and Fruitflow-II (CCIRF-II)
NCT01766180
Brain Response to an Intervention Using Guided, At-Home Technology for the Mind
NCT05912556
Augmentation of Cognitive Training in Children With TBI With D-Cyloserine
NCT02312635
Effect of Frontal Transcranial Direct Current Stimulation on BDNF in Stroke Patients With Cognitive Impairment
NCT06386614
High Definition Transcranial Direct Current Stimulation (HD-tDCS) in Patients With Mild Cognitive Impairment
NCT04121156
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
In an optional substudy, fMRI (functional magnetic resonance imaging) with gadolinium contrast will be conducted to measure dentate gyrus function before randomization and then after completion of the 12-week intervention portion of the trial.
\*see note in Record Log regarding the change in the method of assessment of cocoa flavanol content of the capsules
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
F 0 mg
daily consumption of capsules containing 0 mg cocoa flavanol for 12 weeks
Cocoa Flavanol
12 weeks administration of cocoa flavanol
F 260 mg
daily consumption of capsules containing 260 mg\* cocoa flavanol for 12 weeks
\*see note in Record Log regarding the change in the method of assessment of cocoa flavanol content of the capsules
Cocoa Flavanol
12 weeks administration of cocoa flavanol
F 510 mg
daily consumption of capsules containing 510 mg cocoa flavanol for 12 weeks
Cocoa Flavanol
12 weeks administration of cocoa flavanol
F 770 mg
daily consumption of capsules containing 770 mg cocoa flavanol for 12 weeks
Cocoa Flavanol
12 weeks administration of cocoa flavanol
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cocoa Flavanol
12 weeks administration of cocoa flavanol
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2\. Healthy Male or Female subjects. (Females must be post-menopausal) Telephone Screen
3\. Age between 50 and 75 years, both inclusive. Telephone Screen
4\. Body mass index between 18.0 and 35 kg/m², both inclusive. Telephone Screen
Exclusion Criteria
2. Clinically significant abnormal hematology, biochemistry, urinalysis, or coagulation screening tests, as judged by the Investigator. Medical History Interview
3. History or presence of cancer (except basal cell skin cancer or squamous cell skin cancer), or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological (with the exception euthyroid struma), haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders as judged by the Investigator. Medical History Interview
4. Seated blood pressure at screening (after resting for 5 min in seated position) outside the range of 90-140 mmHg for systolic or 50-90 mmHg for diastolic (excluding white-coat hypertension; therefore, if a repeated measurement shows values within the range, the subject can be included in the trial) and/or resting supine heart rate outside the range 50-90 beats per minute. Measurement taken at consent before eligibility is determined
5. Current Depression or Anxiety Symptoms using PHQ-8 (eight-item Patient Health Questionnaire depression scale) and GAD-7 (Generalized Anxiety Disorder 7-item scale). PHQ-8 score \>= 10 and/or GAD-7 score \>= 10 are excluded.
(Past history of disorders not exclusionary). Interview
6. Currently taking SSRI (selective serotonin reuptake inhibitor) medications for any reason. Interview
7. Heart Diseases. Medical History Interview
8. Hepatitis B or C positive status. Medical History Interview
9. HIV positive status. Medical History Interview
10. History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction. Medical History Interview
11. Use of non-prescription medication, herbal products or nutritional supplements during the study, and within the last 4 weeks before the start of the study (screening), as judged by the Investigator; occasional use of aspirin, ibuprofen, acetaminophen is permitted. Interview
12. Adherence to a vegan or vegetarian diet or to specialty/uncommon diets. Interview
13. Food Allergies to tree nuts, soy, cocoa and cocoa-containing products. Interview
14. People who choose to avoid caffeine intake. Interview
15. Current or history of alcoholism or drug/chemical abuse as per Investigator's judgment. Medical History Interview
16. Hormone Replacement Therapy; Currently pregnant; Pregnant or lactating within past 6 mos; Hormonal birth control (pill). Interview
17. Smoking. Interview
18. Unwilling to have blood drawn or anxiety/nausea during a blood draw. Interview.
19. Uncomfortable completing memory and attention tasks in the English language. Interview
20. MoCA (Montreal Cognitive Assessment) score less than 26. Montreal Cognitive Assessment
21. Inability to swallow study capsules. Interview (at consent).
22. Did not complete the two weeks Run-In Period (Participants who missed more than 2 intake occasions out of 14 days (28 occasions total) or if there are \> 8 capsules left in the bottle after the two weeks will be excluded). Run-In Period.
MRI RELATED
1. Cardiac Pacemaker Interview
2. Internal Pump Interview
3. Insulin Pump Interview
4. Tattoo eyeliner Interview
5. Wire sutures Interview
6. Internal Metal Objects Interview
7. Metal Slivers in Eye Interview
8. Prosthesis Interview
9. Hearing Aid Implants Interview
10. Neurostimulator Interview
11. Metal Fragments Interview
12. Brain Aneurysm Clips Interview
13. Vascular Clips Interview
14. Breast Expander Interview
15. Vena Cava Filter Interview
16. Heart Valve Interview
17. Metal Stents Interview
18. Asthma Interview
19. Hay-Fever Interview
20. Sickle Cell Disease Interview
21. Kidney Disease Interview
22. Pregnant Interview
23. Claustrophobic Interview
24. Wheelchair bound Interview
25. Machinist or ever worked with heavy metals Interview
26. Contraindication to Gadolinium, including prior adverse reaction to gadolinium, past or current history of severe breathing difficulty that has been treated by a physician (e.g. asthma, COPD (Chronic obstructive pulmonary disease), etc) and sickle cell disease. History of renal impairment or estimated glomerular filtration rate \<30 L/min.1.732m2 is also exclusionary Interview; Glomerular filtration rate assessed with creatinine via StatSensor monitor
27. Had more than one previous MRI scans with Gadolinium Interview
50 Years
75 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Mars, Inc.
INDUSTRY
New York State Psychiatric Institute
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Richard Sloan
Research Scientist / Professor of Behavioral Medicine (in Psychiatry)
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Scott A Small, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Columbia University Medical Center
New York, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Brickman AM, Khan UA, Provenzano FA, Yeung LK, Suzuki W, Schroeter H, Wall M, Sloan RP, Small SA. Enhancing dentate gyrus function with dietary flavanols improves cognition in older adults. Nat Neurosci. 2014 Dec;17(12):1798-803. doi: 10.1038/nn.3850. Epub 2014 Oct 26.
Bussy U , May BR , Olanrewaju Y , Hewitt G , Anderson N , Crozier A , Ottaviani JI , Kwik-Uribe C . Reliable, accessible and transferable method for the quantification of flavanols and procyanidins in foodstuffs and dietary supplements. Food Funct. 2020 Jan 29;11(1):131-138. doi: 10.1039/c9fo02762a.
Ottaviani JI, Fong R, Kimball J, Ensunsa JL, Britten A, Lucarelli D, Luben R, Grace PB, Mawson DH, Tym A, Wierzbicki A, Khaw KT, Schroeter H, Kuhnle GGC. Evaluation at scale of microbiome-derived metabolites as biomarker of flavan-3-ol intake in epidemiological studies. Sci Rep. 2018 Jun 29;8(1):9859. doi: 10.1038/s41598-018-28333-w.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Informed Consent Form
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
7034
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.