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

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

6

Phase

  • 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

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
Intervention / Treatment
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

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

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

USDA Human Nutrition Research Center on Aging

Investigators

  • 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)

February 1, 2019

Primary Completion (Actual)

October 1, 2021

Study Completion (Actual)

April 30, 2023

Study Registration Dates

First Submitted

November 7, 2018

First Submitted That Met QC Criteria

November 13, 2018

First Posted (Actual)

November 16, 2018

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

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