Different Types of Fruits on Metabolic Function and Cognitive Performance

Completed · Not applicable

Conditions studied: Healthy

In brief

Primary objective is to assess the effect of the intake of different types of fruits on memory and attention. Secondary objective is to assess effect of intake of different types of fruits on metabolic markers, including glucose, insulin, total cholesterol and triglyceride and the pharmacokinetic profile of the anthocyanins.

Key facts

Study ID

NCT02736331

Run by

Clinical Nutrition Research Center, Illinois Institute of Technology

People needed

40

Starts

2016-03-02

Expected to finish

2020-07-30

Last updated by the study team

2021-07-27

Who can join

Age: 40 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• • Subject is male or female aged between 40 and 65 years of age
• Subject has BMI between 18.5 and 34.9 kg/m2, (inclusive) at screening visit
• Fasting blood sugar less than 126 mg/dL
• Average Blood pressure less than 160/100 mmHg
• Subject is willing to maintain a stable body weight and to follow his/her regular diet and physical activity patterns throughout the study period.
• Subject is willing to refrain from vigorous physical activity and consumption of alcoholic and/or caffeinated beverages 24 h prior to each test day
• Subject does not smoke or has abstained from smoking for at least 2 years
• No clinical evidence of cardiovascular, metabolic, respiratory, renal, gastrointestinal or hepatic disease
• Not taking any medications or dietary supplements that would interfere with outcomes of the study.

You may not qualify if…

• • Subject currently smokes or has smoked within the past 2 years
• Subject works overnight i.e. the night shift
• Subjects who have a significant sleep disorder, a traumatic brain injury, have a learning disability or attention deficit disorder or any psychiatric or neurological disturbances
• Subject is color blind, has impaired cognitive performance on the flanker test (score <60 at screening) or has a vein access score <7
• Men and women with known or suspected food intolerance, allergies or hypersensitivity to the study materials or closely related compounds
• Men and women known to have/diagnosed with diabetes mellitus
• Men and women with a fasting blood glucose concentration ≥126 mg/dL
• Average blood pressure > 160/100 mmHg during screening visit
• Men and women with documented vascular disease, e.g., heart failure, myocardial infarction, stroke, angina, related surgeries
• Men and women with cancer other than non-melanoma skin cancer in previous 2 years
• Men and women who are taking medication or dietary supplements that may interfere with the study procedures or the endpoints of the study (e.g. antioxidants, anti-inflammatory medications, antidepressant medications, oral and injectable hypoglycemic medications, GI medications, antibiotics, diuretics, adrenergic blockers etc.) Subjects may choose to go off dietary supplements (requires 30 days washout)
• Men and women taking antibiotics within 5 days of study start
• Men and women who have donated blood/plasma within 3 months of the screening visit and blood donors/participants for whom participation in this study will result in having donated more than 1500 milliliters of blood in the previous 12 months
• Substance (alcohol or drug) abuse within the last 2 years
• Excessive coffee and tea consumption (> 4 cups/day)
• Unstable body weight fluctuations of >4.5kg (9.9lbs) in the past 4 weeks
• Women who are known to be pregnant or who are intending to become pregnant over the course of the study and women who are lactating.
• Men and women whom investigator is uncertain about subject's capability or willingness to comply with protocol requirements
• Women who are taking unstable dose and brand of hormonal contraceptives and/or stable dose and brand less than 6 months.
• Men and women who do excessive exercise regularly or are athlete

Where it is running

• Clinical Nutrition Research Center — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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