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Acute Raspberry Intake on Metabolic Control and Cognitive Function

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ClinicalTrials.gov Identifier: NCT03743792
Recruitment Status : Recruiting
First Posted : November 16, 2018
Last Update Posted : March 25, 2019
Sponsor:
Information provided by (Responsible Party):
USDA Human Nutrition Research Center on Aging

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.

Condition or disease Intervention/treatment Phase
Aging Age-related Cognitive Decline Obesity Dietary Supplement: Active breakfast Dietary Supplement: Control breakfast Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: The Effects of Acute Raspberry Intake on the Relationship Between Enhanced Metabolic Control and Cognitive and Psychomotor Function
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Arm Intervention/treatment
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

Placebo Comparator: Placebo
Placebo breakfast
Dietary Supplement: Control breakfast
Control drink + buttermilk biscuit sandwich




Primary Outcome Measures :
  1. Psychomotor function [ Time Frame: Baseline to 6 hours ]
    Psychomotor function will be measured with the Grooved Pegboard


Secondary Outcome Measures :
  1. Endothelial function [ Time Frame: Baseline to 5 hours ]
    Vascular assessments will be measured using Near-infrared spectroscopy (NIRS)



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Ages Eligible for Study:   55 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03743792


Contacts
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Contact: Kimberly Dupiton 617-556-3012 Kimberly.Dupiton@tufts.edu
Contact: Grant A Rutledge, PhD 617-556-3366 Grant.Rutledge@tufts.edu

Locations
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United States, Massachusetts
USDA Human Nutrition Research Center on Aging Recruiting
Boston, Massachusetts, United States, 02111
Contact: Kimberly Dupiton    617-556-3366    Kimberly.Dupiton@tufts.edu   
Principal Investigator: Tammy M Scott, PhD         
Sub-Investigator: Barbara Shukitt-Hale, PhD         
Sub-Investigator: Grant A Rutledge, PhD         
Sponsors and Collaborators
USDA Human Nutrition Research Center on Aging
Investigators
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Principal Investigator: Barbara Shukitt-Hale, PhD USDA Human Nutrition Research Center on Aging
Principal Investigator: Tammy M Scott, PhD Tufts University

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Responsible Party: USDA Human Nutrition Research Center on Aging
ClinicalTrials.gov Identifier: NCT03743792     History of Changes
Other Study ID Numbers: 13165
First Posted: November 16, 2018    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by USDA Human Nutrition Research Center on Aging:
Raspberry
Cognition
Vascular function

Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders