Acute Berry Intake on Metabolic Control and Cognitive Function

NCT03879213 | Completed

• 1 other identifier: IRB2018-046
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this study are:

1. 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. 2.Evaluate the effects of acute dietary raspberry on measures of vascular function.

Conditions

Healthy

Keywords

Raspberry; Metabolic responses; Endothelial function; Cognitive function

Outcome Measures

Primary Outcomes (6)

• Changes in Profile of Mood States response between 2 treatments

  Cognitive assessment tasks will be performed in Profile of Mood States

  Baseline to 6 hours

• Changes in Digit Symbol Coding response between 2 treatments

  Cognitive assessment tasks will be performed in Digit Symbol Coding

  Baseline to 6 hours

• Changes in Hopkins Verbal Learning Test response between 2 treatments

  Cognitive assessment tasks will be performed in Hopkins Verbal Learning Test

  Baseline to 6 hours

• Changes in CANTAB- paired-associates-learning response between 2 treatments

  Cognitive assessment tasks will be performed in CANTAB- paired-associates-learning

  Baseline to 6 hours

• Changes in CANTAB- rapid-visual-information-processing response between 2 treatments

  Cognitive assessment tasks will be performed in CANTAB- rapid-visual-information-processing

  Baseline to 6 hours

• Changes in CANTAB- spatial-working-memory response between 2 treatments

  Cognitive assessment tasks will be performed in CANTAB- spatial-working-memory

  Baseline to 6 hours

Secondary Outcomes (2)

• Changes in Psychomotor function between 2 treatments

  Baseline to 6 hours

• Changes in postprandial endothelial function between 2 treatments

  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 breakfast DIETARY_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 breakfast DIETARY_SUPPLEMENT

Control drink + buttermilk biscuit sandwich

Placebo

Eligibility Criteria

• Age: 55 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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)

Sponsors & Collaborators

• Clinical Nutrition Research Center, Illinois Institute of Technology: lead

Study Sites (1)

Clinical Nutrition Research Center

Chicago, Illinois, 60616, United States

Location

Study Officials

• Britt Burton-Freeman, Ph.D

  Illinois Institute of Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single (Participant) Single blinded
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multi center, randomized, single-blind, 2-arm, placebo-controlled, within subject cross-over trial, featuring a repeated postprandial sampling paradigm

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: March 18, 2019
• Study Start: September 17, 2018
• Primary Completion: February 1, 2020
• Study Completion: June 1, 2020
• Last Updated: July 14, 2020

Record last verified: 2020-07

Locations

US (1)