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Acute Raspberry Intake on Metabolic Control and Cognitive Function

Primary Purpose

Aging, Age-related Cognitive Decline, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active breakfast
Control breakfast
Sponsored by
USDA Human Nutrition Research Center on Aging
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Aging focused on measuring Raspberry, Cognition, Vascular function

Eligibility Criteria

55 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • USDA Human Nutrition Research Center on Aging

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active

Placebo

Arm Description

Freeze-dried red raspberry powder (25 g) in active breakfast meal

Placebo breakfast

Outcomes

Primary Outcome Measures

Psychomotor function
Psychomotor function will be measured with the Grooved Pegboard

Secondary Outcome Measures

Endothelial function
Vascular assessments will be measured using Near-infrared spectroscopy (NIRS)

Full Information

First Posted
November 7, 2018
Last Updated
May 9, 2023
Sponsor
USDA Human Nutrition Research Center on Aging
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1. Study Identification

Unique Protocol Identification Number
NCT03743792
Brief Title
Acute Raspberry Intake on Metabolic Control and Cognitive Function
Official Title
The Effects of Acute Raspberry Intake on the Relationship Between Enhanced Metabolic Control and Cognitive and Psychomotor Function
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
October 1, 2021 (Actual)
Study Completion Date
April 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
USDA Human Nutrition Research Center on Aging

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging, Age-related Cognitive Decline, Obesity
Keywords
Raspberry, Cognition, Vascular function

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Experimental
Arm Description
Freeze-dried red raspberry powder (25 g) in active breakfast meal
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo breakfast
Intervention Type
Dietary Supplement
Intervention Name(s)
Active breakfast
Intervention Description
freeze-dried red raspberry powder (12.5 g) in drink+ freeze-dried red raspberry powder (12.5 g) in buttermilk biscuit sandwich
Intervention Type
Dietary Supplement
Intervention Name(s)
Control breakfast
Intervention Description
Control drink + buttermilk biscuit sandwich
Primary Outcome Measure Information:
Title
Psychomotor function
Description
Psychomotor function will be measured with the Grooved Pegboard
Time Frame
Baseline to 6 hours
Secondary Outcome Measure Information:
Title
Endothelial function
Description
Vascular assessments will be measured using Near-infrared spectroscopy (NIRS)
Time Frame
Baseline to 5 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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) 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Shukitt-Hale, PhD
Organizational Affiliation
USDA Human Nutrition Research Center on Aging
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tammy M Scott, PhD
Organizational Affiliation
Tufts University
Official's Role
Principal Investigator
Facility Information:
Facility Name
USDA Human Nutrition Research Center on Aging
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Acute Raspberry Intake on Metabolic Control and Cognitive Function

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