Acute Berry Intake on Metabolic Control and Cognitive Function (RRB3)

Illinois Institute of Technology

Status

Completed

Conditions

Healthy

Treatments

Dietary Supplement: Control breakfast

Dietary Supplement: Active breakfast

Study type

Interventional

Funder types

Industry

Identifiers

NCT03879213

IRB2018-046

Details and patient eligibility

About

The objectives of this study are:

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

Full description

The proposed study will be conducted in humans according to Good Clinical Practice (GCP) guidelines. All subjects will review and sign an Informed Consent Form approved by the Illinois Institute of Technology's Institutional Review Boards (IRB) prior to screening.

This multi-center clinical trial is a randomized, single-blind, 2-arm, placebo-controlled, within subject cross-over trial, featuring a repeated postprandial sampling paradigm to evaluate the effects of acute dietary red raspberry intake on cognitive function, inflammation, insulin sensitivity / glucose handling and vascular function in overweight/obese older adults after consuming a standardized challenge meal.

A planned sample size of 30 will be enrolled into the study. This study will require one initial screening visit and 3 study visits. This study will take approximately 3-4 weeks per subject to complete.

The initial screening visit will provide subject with their site-specific, IRB-approved informed consent document prior to the start of any study related procedures. Subject eligibility will be determined through anthropometric measurements, vital signs, fasting blood glucose test (finger prick), and completion of a survey relate to general eating, health, mood and exercise habits.

Eligible subjects will follow a limited polyphenolic diet throughout the duration of their participation, although stricter guidelines will be imposed during the 3 days prior to a study visit. Shopping lists and meal plans will be provided to subjects, along with counseling by the investigator's study dietitians, to help subjects adhere to the limited polyphenolic diet. The trial will initiate with a 3-day food diary to assess background (pre-study) dietary intake followed by counseling to follow a diet relatively low in (poly)phenolic rich-beverages/foods, which will be maintained for the duration of the experiment. After an initial 7 day run-in period on the limited polyphenolic diet, subjects will be randomized to 1 of 2 treatment sequences. Treatment codes will be maintained by the principal investigator/study physician. All subjects will receive both treatments, once each on 2 different occasions and separated by at least 1 week. Red raspberries or placebo will be provided with a standardized meal providing 840 kcal. A low-polyphenol snack will be provided to subjects after their final cognitive assessment.

Each visit will last ~ 9.5 hours and subjects will be required to remain at the Clinical Unit for the duration of the visit. Blood samples will be collected at 0 (fasting) and at 0.5 h, 1 h, 2 h, 4 h, 5 h, 6 h and 7.5 h via a catheter placed on the non-dominant arm by a registered nurse. Cognitive function will be measured at 0 (fasting), 2 h, and 6 h. FMD or NIRS will be conducted at the CNRC or the HNRCA, respectively at 0 (fasting), and at 1 h and 5 h.

Enrollment

30 patients

Sex

All

Ages

55 to 70 years old

Volunteers

Accepts 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.