Dietary Flavanols and Dentate Gyrus Function

NCT02312310 | Completed Results

• 1 other identifier: 7034
• Study Type: interventional
• Target: 211
• Locations: 1 country
• Sites: 1

Brief Summary

to assess the effect of differing amounts of a cocoa-derived dietary flavanol (epicatechin ) on dentate gyrus function and corresponding cognitive function

Conditions

Memory Loss

Outcome Measures

Primary Outcomes (1)

• Modified Benton Recognition Task (ModBent)

  The ModBent task is divided into two parts. During the matching trials (top), participants were shown a complex stimulus for 10 s. Following a 1-s inter-trial interval, they were required to select, via a key press, which of two stimuli matched the one they had just studied, as quickly and as accurately as possible. Following 41 matching trials, participants were shown a series of 82 stimuli (bottom), 41 of which appeared on the initial study set during the matching trials and 41 of which were foils. They were required to indicate, as quickly as possible, whether each stimulus appeared earlier (yes response) or was new (no response). The primary variable of the ModBent task is the mean RT for correct rejections of foils during the recognition trials

  baseline and 12 weeks

Secondary Outcomes (4)

• Dentate Gyrus Cerebral Blood Volume

  baseline and 12 weeks

• Modified Benton Recognition Task (ModBent)

  20 weeks

• Modified Rey Auditory Verbal Learning Test

  Baseline and 12 Weeks

• NIH Toolbox Cognition Battery (NIHTB-CB): The List Sorting Test

  Baseline and 12 Weeks

Study Arms (4)

F 0 mg

PLACEBO COMPARATOR

daily consumption of capsules containing 0 mg cocoa flavanol for 12 weeks

Dietary Supplement: Cocoa Flavanol

F 260 mg

ACTIVE COMPARATOR

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

Dietary Supplement: Cocoa Flavanol

F 510 mg

ACTIVE COMPARATOR

daily consumption of capsules containing 510 mg cocoa flavanol for 12 weeks

Dietary Supplement: Cocoa Flavanol

F 770 mg

ACTIVE COMPARATOR

daily consumption of capsules containing 770 mg cocoa flavanol for 12 weeks

Dietary Supplement: Cocoa Flavanol

Interventions

Cocoa Flavanol DIETARY_SUPPLEMENT

12 weeks administration of cocoa flavanol

F 0 mg; F 260 mg; F 510 mg; F 770 mg

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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 management of the subject). Telephone Screen
• \. Healthy Male or Female subjects. (Females must be post-menopausal) Telephone Screen
• \. Age between 50 and 75 years, both inclusive. Telephone Screen
• \. Body mass index between 18.0 and 35 kg/m², both inclusive. Telephone Screen

You may not qualify if:

• Currently undergoing medical treatment, including prescription drugs/medication. Medical History Interview
• Clinically significant abnormal hematology, biochemistry, urinalysis, or coagulation screening tests, as judged by the Investigator. Medical History Interview
• 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
• 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
• 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.
• Currently taking SSRI (selective serotonin reuptake inhibitor) medications for any reason. Interview
• Heart Diseases. Medical History Interview
• Hepatitis B or C positive status. Medical History Interview
• HIV positive status. Medical History Interview
• History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction. Medical History Interview
• 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
• Adherence to a vegan or vegetarian diet or to specialty/uncommon diets. Interview
• Food Allergies to tree nuts, soy, cocoa and cocoa-containing products. Interview
• People who choose to avoid caffeine intake. Interview
• Current or history of alcoholism or drug/chemical abuse as per Investigator's judgment. Medical History Interview

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• Mars, Inc.: collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (3)

• 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.

  PMID: 25344629 BACKGROUND

• 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.

  PMID: 31932823 BACKGROUND

• 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.

  PMID: 29959422 BACKGROUND

MeSH Terms

Conditions

Memory Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Scott A. Small, MD
• Organization: Columbia University Medical Center

sas68@columbia.edu

212-305-1269

Study Officials

• Scott A Small, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist / Professor of Behavioral Medicine (in Psychiatry)

Study Record Dates

• First Submitted: December 5, 2014
• First Posted: December 9, 2014
• Study Start: December 1, 2015
• Primary Completion: November 1, 2018
• Study Completion: April 1, 2020
• Last Updated: June 11, 2020
• Results First Posted: June 11, 2020

Record last verified: 2020-06

Locations

US (1)