Different Types of Fruits on Metabolic Function and Cognitive Performance

NCT02736331 | Completed

• 1 other identifier: IRB2015-105
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Cognitive performance; Metabolic control; Pharmacokinetic profile; Anthocyanins

Outcome Measures

Primary Outcomes (1)

• Changes in memory function using the Montreal Cognitive Assessment after intake of different types of fruits

  Sum all sub-scores of the Montreal Cognitive Assessment

  8 hours Postprandial Study

Secondary Outcomes (4)

• Changes in plasma glucose concentrations after intake of different types of fruits

  8 hours Postprandial Study

• Changes in plasma insulin concentrations after intake of different types of fruits

  8 hours Postprandial Study

• Changes in plasma Triglycerides Concentrations after intake of different types of fruits

  8 hours Postprandial Study

• Changes in plasma Total Cholesterol Concentrations after intake of different types of fruits

  8 hours Postprandial Study

Other Outcomes (6)

• Changes in polyphenol anthocyanin concentrations after intake of different types of fruits

  8 hours Postprandial Study

• Changes in LDL oxidation after intake of different types of fruits

  8 hours Postprandial Study

• Changes in IL-6 after intake of different types of fruits

  8 hours Postprandial Study

Study Arms (2)

Treatment 1 Beverage

EXPERIMENTAL

Treatment 1

Dietary Supplement: Treatment 1

Treatment 2 Beverage

PLACEBO COMPARATOR

Treatment 2

Dietary Supplement: Treatment 2

Interventions

Treatment 1 DIETARY_SUPPLEMENT

Treatment 1 Beverage

Treatment 1 Beverage

Treatment 2 DIETARY_SUPPLEMENT

Treatment 2 Beverage

Treatment 2 Beverage

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• Clinical Nutrition Research Center, Illinois Institute of Technology: lead

Study Sites (1)

Clinical Nutrition Research Center

Chicago, Illinois, 60616, United States

Location

Study Officials

• Britt Burton-Freeman, Ph.D

  Illinois Institute of Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2016
• First Posted: April 13, 2016
• Study Start: March 2, 2016
• Primary Completion: October 30, 2019
• Study Completion: July 30, 2020
• Last Updated: July 27, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)