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Clinical Trials/NCT03743792
NCT03743792
Completed
Not Applicable

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

USDA Human Nutrition Research Center on Aging1 site in 1 country6 target enrollmentFebruary 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aging
Sponsor
USDA Human Nutrition Research Center on Aging
Enrollment
6
Locations
1
Primary Endpoint
Psychomotor function
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

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

Registry
clinicaltrials.gov
Start Date
February 1, 2019
End Date
April 30, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
USDA Human Nutrition Research Center on Aging
Responsible Party
Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Psychomotor function

Time Frame: Baseline to 6 hours

Psychomotor function will be measured with the Grooved Pegboard

Secondary Outcomes

  • Endothelial function(Baseline to 5 hours)

Study Sites (1)

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