NCT03743792

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 16, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

2.7 years

First QC Date

November 7, 2018

Last Update Submit

May 9, 2023

Conditions

AgingAge-related Cognitive DeclineObesity

Keywords

RaspberryCognitionVascular function

Outcome Measures

Primary Outcomes (1)

  • Psychomotor function

    Psychomotor function will be measured with the Grooved Pegboard

    Baseline to 6 hours

Secondary Outcomes (1)

  • Endothelial function

    Baseline to 5 hours

Study Arms (2)

Active

EXPERIMENTAL

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

Dietary Supplement: Active breakfast

Placebo

PLACEBO COMPARATOR

Placebo breakfast

Dietary Supplement: Control breakfast

Interventions

Active breakfastDIETARY_SUPPLEMENT

freeze-dried red raspberry powder (12.5 g) in drink+ freeze-dried red raspberry powder (12.5 g) in buttermilk biscuit sandwich

Active
Control breakfastDIETARY_SUPPLEMENT

Control drink + buttermilk biscuit sandwich

Placebo

Eligibility Criteria

Age55 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USDA Human Nutrition Research Center on Aging

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Barbara Shukitt-Hale, PhD

    USDA Human Nutrition Research Center on Aging

    PRINCIPAL INVESTIGATOR

  • Tammy M Scott, PhD

    Tufts University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2018

First Posted

November 16, 2018

Study Start

February 1, 2019

Primary Completion

October 1, 2021

Study Completion

April 30, 2023

Last Updated

May 10, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)