Healthy Clinical Trial
— RRB3Official title:
The Effects of Acute Raspberry Intake on the Relationship Between Enhanced Metabolic Control and Cognitive and Psychomotor Function
Verified date | July 2020 |
Source | Clinical Nutrition Research Center, Illinois Institute of Technology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objectives of this study are:
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | June 1, 2020 |
Est. primary completion date | February 1, 2020 |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Clinical Nutrition Research Center | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Clinical Nutrition Research Center, Illinois Institute of Technology |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | Changes in Digit Symbol Coding response between 2 treatments | Cognitive assessment tasks will be performed in Digit Symbol Coding | Baseline to 6 hours | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Changes in Psychomotor function between 2 treatments | Psychomotor function will be measured with the Grooved Pegboard | Baseline to 6 hours | |
Secondary | Changes in postprandial endothelial function between 2 treatments | Vascular Assessments will be measured with Flow mediated vasodilation (FMD) | Baseline to 5 hours |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06052553 -
A Study of TopSpin360 Training Device
|
N/A | |
Completed |
NCT05511077 -
Biomarkers of Oat Product Intake: The BiOAT Marker Study
|
N/A | |
Recruiting |
NCT04632485 -
Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
|
||
Completed |
NCT05931237 -
Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults
|
N/A | |
Completed |
NCT04527718 -
Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers
|
Phase 1 | |
Terminated |
NCT04556032 -
Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women
|
N/A | |
Completed |
NCT04107441 -
AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects
|
Phase 1 | |
Completed |
NCT04065295 -
A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225
|
Phase 1 | |
Completed |
NCT04998695 -
Health Effects of Consuming Olive Pomace Oil
|
N/A | |
Completed |
NCT01442831 -
Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects
|
Phase 1 | |
Terminated |
NCT05934942 -
A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood
|
Phase 1 | |
Recruiting |
NCT05525845 -
Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI
|
N/A | |
Completed |
NCT05515328 -
A Study in Healthy Men to Test How BI 685509 is Processed in the Body
|
Phase 1 | |
Completed |
NCT05030857 -
Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects
|
Phase 1 | |
Completed |
NCT04967157 -
Cognitive Effects of Citicoline on Attention in Healthy Men and Women
|
N/A | |
Recruiting |
NCT04494269 -
A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls
|
Phase 1 | |
Recruiting |
NCT04714294 -
Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT04539756 -
Writing Activities and Emotions
|
N/A | |
Recruiting |
NCT04098510 -
Concentration of MitoQ in Human Skeletal Muscle
|
N/A | |
Completed |
NCT03308110 -
Bioavailability and Food Effect Study of Two Formulations of PF-06650833
|
Phase 1 |