Acute Berry Intake on Metabolic Control and Cognitive Function
NCT ID: NCT03879213
Last Updated: 2020-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
30 participants
INTERVENTIONAL
2018-09-17
2020-06-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Acute Raspberry Intake on Metabolic Control and Cognitive Function
NCT03743792
Effect of Raspberry on Gut Microbiota and Metabolic Syndrome
NCT03620617
The Impact of Cranberries On the Microbiome and the Brain in Healthy Ageing sTudy (COMBAT)
NCT03679533
The Effects of Strawberry Supplementation on Memory and Gait Among Over-weight Older Adults
NCT03162913
The Acute Effect of Two Berry Extracts on Cognition and Mood in Adults Aged 40 to 60
NCT02810769
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
OTHER
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Active
freeze-dried red raspberry powder (25 g) in active breakfast meal
Active breakfast
freeze-dried red raspberry powder (12.5 g) in drink+ freeze-dried red raspberry powder (12.5 g) in buttermilk biscuit sandwich
Placebo
Placebo breakfast
Control breakfast
Control drink + buttermilk biscuit sandwich
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
55 Years
70 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Clinical Nutrition Research Center, Illinois Institute of Technology
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Britt Burton-Freeman, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Illinois Institute of Technology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Clinical Nutrition Research Center
Chicago, Illinois, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRB2018-046
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.