Memory LossNCT03723694
Dietary Modulation of Neuroinflammation in Age-Related Memory Disorders
A study testing 650 mg of Cocoapro flavanols and 0 mg of Cocoapro flavanols in people with Memory Loss and Inflammation, run by Columbia University at 1 site in United States.
Trial summary
The purpose of this study is to test the effect of a cocoa-derived dietary flavanol on brain structures and cognitive outcomes in a 12-week randomized controlled trial of 146 healthy participants, age 50-69, who will receive this cocoa derivative or a placebo. Read more about this study
- Who is it for?
- Ages 50 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Memory Loss, Inflammation
- What is being tested?
- 650 mg of Cocoapro flavanols and 0 mg of Cocoapro flavanols
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 259 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2019to 26 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed and dated informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal screening or management of the subject).
- Healthy Male or Female subjects. (Females must be post-menopausal)
- Age between 50 and 69 years, both inclusive.
- Body mass index between 18.0 and 35 kg/m², both inclusive.
Who cannot join
- Currently undergoing medical treatment, including prescription drugs/medication.
- Clinically significant abnormal hematology, biochemistry, urinalysis, or coagulation screening tests, as judged by the Investigator.
- 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.
- 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
- Heart Diseases.
- Hepatitis B or C positive status.
Show all 40Show fewer
- HIV positive status.
- History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
- 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.
- Adherence to a vegan or vegetarian diet or to specialty/uncommon diets.
- Food Allergies to tree nuts, soy, cocoa and cocoa-containing products.
- People who choose to avoid caffeine intake.
- Current or history of alcoholism or drug/chemical abuse as per Investigator's judgment.
- Hormone Replacement Therapy; Currently pregnant; Pregnant or Interview\ lactating within past 6 months; Hormonal birth control (pill).
- Smoking.
- Unwilling to have blood drawn or anxiety/nausea during a blood draw.
- Uncomfortable completing memory and attention tasks in the English language
- Montreal Cognitive Assessment (MoCA) score less than 26.
- Inability to swallow study capsules Interview (at Consent)
- 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).
- MRI RELATED
- Cardiac Pacemaker
- Internal Pump
- Insulin Pump
- Tattoo eyeliner
- Wire sutures
- Internal Metal Objects
- Metal Slivers in Eye
- Prosthesis
- Hearing Aid Implants
- Neurostimulator
- Metal Fragments
- Brain Aneurysm Clips
- Vascular Clips
- Breast Expander
- Vena Cava Filter
- Heart Valve
- Metal Stents
- Asthmatic symptoms within the past 3 years
- Sickle Cell Disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
The purpose of this study is to test the effect of a cocoa-derived dietary flavanol on brain structures and cognitive outcomes in a 12-week randomized controlled trial of 146 healthy participants, age 50-69, who will receive this cocoa derivative or a placebo. Th investigators will also examine the role of inflammation in this relationship.
Read the detailed description
Within 25 years, the US population aged 65 and over will double in size to 80 million bringing, with it an epidemic of aging-related cognitive decline, from normal cognitive aging to neurodegenerative disorders including Alzheimer's Disease. These conditions impair quality of life and functional status, impose an enormous burden on individuals, their families, the healthcare system, and require elucidation of mechanisms and development of new treatments to prevent or at least slow their progression. The use of plant-based food and drink for health purposes has a long and well-documented history. Cocoa beans contain a substance that has multiple beneficial health effects. In this study, the investigators will test the effect of this substance on brain structures and cognitive outcomes in a 12-week randomized controlled trial of 146 healthy participants, age 50-69, who will receive this cocoa derivative or a placebo. The investigators also will examine the role of inflammation in this relationship. Such a trial has potential for significant clinical impact.
- Conditions
- Memory Loss, Inflammation
- Being tested
- 650 mg of Cocoapro flavanols, 0 mg of Cocoapro flavanols
- Keywords
- Flavanol, Cocoapro
- Medical subject headings
- Memory Disorders, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
650 mg of Cocoapro flavanolsDietary supplement
12-week period during which participant will be asked to consume two cocoa-flavanol-containing capsules(650mg) twice a day with meals.
0 mg of Cocoapro flavanolsDietary supplement
12-week period during which participant will be asked to consume two cocoa-flavanol-containing capsules(0mg) twice a day with meals.
| Study group | Role | What they receive |
|---|---|---|
| 650 mg of Cocoapro flavanols | Active comparator | Daily, each subject will consume either two cocoa flavanol-containing capsules twice a day with a meal. Receives: Dietary Supplement: 650 mg of Cocoapro flavanols |
| 0mg Cocoapro flavanols | Placebo comparator | Daily, each subject will consume either ttwo placebo-containing capsules twice a day with a meal. Receives: Dietary Supplement: 0 mg of Cocoapro flavanols |
What is being measured
The primary outcome is the main question the study is designed to answer.
HMGB1
circulating levels of the inflammatory marker HMGB1
Measured: 12 weeks
Secondary outcomes (2)
NFkB
TLR4-dependent NFkB
Measured: 12 weeks
TNFa
TLR4-dependent TNFa
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2018
- Study start1 Jan 2019
- Primary completion5 Mar 2023
- Study completion26 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Memory LossStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 259 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Richard P Sloan PhD, Columbia University
- Investigators
- Richard P. Sloan, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03723694
- Sponsor's protocol ID
- NYSPI 7665
- Other IDs
- 5R01AG058417
- Status last verified
- Aug 2024
- First submitted
- 24 Oct 2018
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 25344629
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Modulation of Neuroinflammation in Age-Related Memory Disorders
- ClinicalTrials.gov ID
- NCT03723694
- Acronym / sponsor ID
- NYSPI 7665
- Conditions
- Memory Loss, Inflammation
- Keywords
- Flavanol, Cocoapro
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 259 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 5 Mar 2023 (actual)
- Study completion
- 26 Jun 2023 (actual)
- First posted
- 29 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test the effect of a cocoa-derived dietary flavanol on brain structures and cognitive outcomes in a 12-week randomized controlled trial of 146 healthy participants, age 50-69, who will receive this cocoa derivative or a placebo. Th investigators will also examine the role of inflammation in this relationship.
Detailed description
Within 25 years, the US population aged 65 and over will double in size to 80 million bringing, with it an epidemic of aging-related cognitive decline, from normal cognitive aging to neurodegenerative disorders including Alzheimer's Disease. These conditions impair quality of life and functional status, impose an enormous burden on individuals, their families, the healthcare system, and require elucidation of mechanisms and development of new treatments to prevent or at least slow their progression. The use of plant-based food and drink for health purposes has a long and well-documented history. Cocoa beans contain a substance that has multiple beneficial health effects. In this study, the investigators will test the effect of this substance on brain structures and cognitive outcomes in a 12-week randomized controlled trial of 146 healthy participants, age 50-69, who will receive this cocoa derivative or a placebo. The investigators also will examine the role of inflammation in this relationship. Such a trial has potential for significant clinical impact.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 650 mg of Cocoapro flavanols | Active comparator | Dietary Supplement: 650 mg of Cocoapro flavanolsDaily, each subject will consume either two cocoa flavanol-containing capsules twice a day with a meal. |
| 0mg Cocoapro flavanols | Placebo comparator | Dietary Supplement: 0 mg of Cocoapro flavanolsDaily, each subject will consume either ttwo placebo-containing capsules twice a day with a meal. |
Who may qualify
- Ages
- 50 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed and dated informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal screening or management of the subject).
- Healthy Male or Female subjects. (Females must be post-menopausal)
- Age between 50 and 69 years, both inclusive.
- Body mass index between 18.0 and 35 kg/m², both inclusive.
Key exclusion criteria (40 listed)
- Currently undergoing medical treatment, including prescription drugs/medication.
- Clinically significant abnormal hematology, biochemistry, urinalysis, or coagulation screening tests, as judged by the Investigator.
- 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.
- 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
- Heart Diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 650 mg of Cocoapro flavanols12-week period during which participant will be asked to consume two cocoa-flavanol-containing capsules(650mg) twice a day with meals. | Dietary supplement | 650 mg of Cocoapro flavanols |
| 0 mg of Cocoapro flavanols12-week period during which participant will be asked to consume two cocoa-flavanol-containing capsules(0mg) twice a day with meals. | Dietary supplement | 0mg Cocoapro flavanols |
Primary outcome
HMGB1
Time frame: 12 weeks
circulating levels of the inflammatory marker HMGB1
2 secondary outcomes
NFkB
Time frame: 12 weeks
TNFa
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Background: PubMed 25344629Brickman 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.
Related trials for Memory Loss
Not yet recruitingPhase 4
Effect of Midazolam Given at Induction on Recall of Propofol Injection Pain
Propofol Injection Pain, Postoperative Recall of Pain
Active, not recruiting
The PorchLight Project
Memory Loss, Alzheimer Disease
Recruiting
OCT-Angiography and Adaptive Optics in Patients With Memory Impairment
Amnesia, Alzheimer Disease
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Choose Myself (Before) Losing Myself
Dementia (Diagnosis), Mild Cognitive Impairment
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard P. Sloan, PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 650 mg of Cocoapro flavanols and 0 mg of Cocoapro flavanols in people with Memory Loss and Inflammation, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HMGB1 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03723694, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.