Acute Raspberry Intake on Metabolic Control and Cognitive Function

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03743792
• Other study ID #: 13165
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: April 30, 2023

Study information

• Verified date: May 2023
• Source: USDA Human Nutrition Research Center on Aging
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: April 30, 2023
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Age-related Cognitive Decline
• Aging
• Cognitive Dysfunction
• Obesity

Intervention

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
• Control breakfast
Control drink + buttermilk biscuit sandwich

Locations

Country	Name	City	State
United States	USDA Human Nutrition Research Center on Aging	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
USDA Human Nutrition Research Center on Aging

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychomotor function	Psychomotor function will be measured with the Grooved Pegboard	Baseline to 6 hours
Secondary	Endothelial function	Vascular assessments will be measured using Near-infrared spectroscopy (NIRS)	Baseline to 5 hours