Acute Raspberry Intake on Metabolic Control and Cognitive Function

May 9, 2023 updated by: USDA Human Nutrition Research Center on Aging

The Effects of Acute Raspberry Intake on the Relationship Between Enhanced Metabolic Control and Cognitive and Psychomotor Function

The purpose of this project is to determine whether restoring the post-prandial metabolic/inflammatory balance via supplementation with raspberries results in improved cognitive performance, and if these enhancements are mediated through improvements in vascular function.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study will investigate the effects of red raspberry in a relevant human model of metabolic disturbance to understand the relationship between red raspberry intake, metabolic and immune- balance and cognitive and psychomotor performance in older/over weight adults. A secondary goal of the project is to provide data on central vascular function in relation to metabolic-, inflammatory- and cognitive outcomes. Our primary working hypothesis is that red raspberries will improve metabolic- / inflammatory- balance in older overweight and obese adults resulting in improved cognitive and psychomotor performance mediated in part through improvements in vascular function. Two main objectives have been devised to meet the goals of the project and test our hypotheses: 1) Evaluate the effects of acute dietary raspberry intake on metabolic-associated impairments in cognitive and psychomotor function in overweight/obese adults (55-70y) following a meal challenge. 2) Evaluate the effects of acute dietary raspberry on measures of vascular function

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • USDA Human Nutrition Research Center on Aging

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

55 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • BMI between 27 and 35 kg/m2 and/or waist circumference (>35 inches for women, >40 inches for men)
  • Aged 55-70 years old
  • Able to provide informed consent and comply with study procedures
  • Willing to maintain stable body weight and follow his/her habitual diet and physical activity patterns throughout the trial.
  • Judged by the Investigator to be in general good health on the basis of medical history and screening laboratory tests.

Exclusion Criteria:

  • Current smoker and/or marijuana user, past smokers may be allowed in the study if stopped >2 years
  • Have a history or presence of atherosclerotic cardiovascular disease, inflammatory disease, diabetes mellitus, or other systemic diseases, psychological or psychiatric disorders
  • Have recent surgery or injury to head
  • Mini-Mental Status Exam score < 24 or Beck Depression Inventory score > 20
  • Taking any medications that would interfere with outcomes of the study (i.e., lipid- lowering medications, anti-inflammatory drugs, and supplements, not including multivitamin/mineral or calcium/Vit D supplements),
  • Unstable use of any medication/supplement
  • Have a history of cancer in the prior 5 years, except for non-melanoma skin cancer
  • Addicted to drugs and/or alcohol (>2 drinks/day)
  • Have been exposed to any non-registered drug product within last 30 days.
  • Working overnight (e.g. 3rd shift of overnight workers)
  • Excessive exercisers or trained athletes
  • Have allergies/intolerances to berries.
  • Vegetarian/vegan or have extreme dietary habits.
  • Excessive coffee/tea drinker
  • Actively losing weight/ trying to lose weight (unstable body weight fluctuations of > 5 kg in 3 months)
  • Donated blood within last 3 months
  • Female who is pregnant, planning to be pregnant, breastfeeding
  • Current regular consumption of berries which exceeds > 2 servings per day
  • The individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent or comply with the study protocol, or which might confound the interpretation of the study results or put the person at undue risk.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Placebo breakfast
Dietary supplement: Control breakfast
Control drink + buttermilk biscuit sandwich
Experimental: Active
Freeze-dried red raspberry powder (25 g) in active breakfast meal
Dietary supplement: Active breakfast
freeze-dried red raspberry powder (12.5 g) in drink+ freeze-dried red raspberry powder (12.5 g) in buttermilk biscuit sandwich

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Psychomotor function
Time Frame: Baseline to 6 hours
Psychomotor function will be measured with the Grooved Pegboard
Baseline to 6 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Endothelial function
Time Frame: Baseline to 5 hours
Vascular assessments will be measured using Near-infrared spectroscopy (NIRS)
Baseline to 5 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
USDA Human Nutrition Research Center on Aging

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tammy M Scott, PhD, Tufts University
  • Principal Investigator: Barbara Shukitt-Hale, PhD, USDA Human Nutrition Research Center on Aging

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 7, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 16, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 10, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 13165

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings