Characterization of Wild Blueberry Polyphenols Bioavailability and Kinetic Profile Over 24-hour Period

NCT02167555 | Completed

• 1 other identifier: 2014-020
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Primary objective is to characterize the relative bioavailability and kinetic profile of wild blueberry polyphenols over 24-hours period. Secondary objective is to examine the relationship between bioavailability and kinetic profile of wild blueberry polyphenols on markers of chronic diseases.

Conditions

Overweight; Obese; Healthy

Keywords

Wild Blueberries; Polyphenolics

Outcome Measures

Primary Outcomes (1)

• Changes in plasma and urine polyphenol metabolite concentrations over 24 hours after wild blueberry consumption with a high carbohydrate and high fat meal.

  To assess the kinetic profile and bioavailability of wild blueberry polyphenols when consume with a meal

  24 hours

Secondary Outcomes (1)

• Changes in metabolic and inflammation markers over 24 hours after wild blueberry consumption with a high carbohydrate and high fat meal.

  24 hours

Other Outcomes (1)

• Changes in oxidative stress markers over 24 hours after wild blueberry consumption with a high carbohydrate and high fat meal

  24 hours

Study Arms (2)

Wild Bluberries

ACTIVE COMPARATOR

Active Comparator

Dietary Supplement: Active Comparator

Placebo

PLACEBO COMPARATOR

Placebo Comparator

Dietary Supplement: Placebo Comparator

Interventions

Active Comparator DIETARY_SUPPLEMENT

Wild Blueberry Beverage

Also known as: Wild Blueberries

Wild Bluberries

Placebo Comparator DIETARY_SUPPLEMENT

Placebo Beverage

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years of age
• Body Mass Index (BMI) range from 25 to 33 kg/m2
• Nonsmoker
• No clinical evidence of cardiovascular, metabolic, respiratory, renal, gastrointestinal or hepatic disease
• Not taking any medications that would interfere with outcomes of the study, i.e. lipid lowering medications, anti-inflammatory drugs, dietary supplements, etc…
• Able to provide informed consent
• Able to comply and perform the procedures requested by the protocol
• Weight stable: not gained or lost weight +/- 5 kg in previous 3 months

You may not qualify if:

• Men and women who smoke
• Past smokers: abstinence for minimum 2 years
• Men and women with known or suspected food intolerance, allergies or hypersensitivity
• Men and women known to have/diagnosed with diabetes mellitus
• Men and women who have fasting blood glucose concentrations \> 110mg/dL
• Men and women who have uncontrolled blood pressure \>120 mmHg/80 mmHg
• Men and women with documented vascular disease, e.g., heart failure, myocardial infarction, stroke, angina, related surgeries, etc...
• Men and women with cancer other than non-melanoma skin cancer in previous 5 years
• Women who are known to be pregnant or who are intending to become pregnant over the course of the study
• Women who are lactating
• Taking medication or dietary supplements that may interfere with the outcomes of the study; e.g., antioxidant supplement, anti-inflammation, lipid lowering medication, blood pressure lowering medication, etc... Subjects may choose to go off dietary supplements (requires 30 days washout); e.g., fish oil, probiotics, etc...
• Men and women who have donated blood 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.
• Men and women who are vegans
• Substance (alcohol or drug) abuse within the last 2 years
• Excessive coffee and tea consumers (\> 4 cups/d) and berry consumers (\>2 cups fresh/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

Related Publications (1)

• Zhong S, Sandhu A, Edirisinghe I, Burton-Freeman B. Characterization of Wild Blueberry Polyphenols Bioavailability and Kinetic Profile in Plasma over 24-h Period in Human Subjects. Mol Nutr Food Res. 2017 Dec;61(12). doi: 10.1002/mnfr.201700405. Epub 2017 Nov 8.

  PMID: 28887907 DERIVED

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Britt Burton-Freeman, Ph.D, MS

  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: June 17, 2014
• First Posted: June 19, 2014
• Study Start: June 1, 2014
• Primary Completion: January 8, 2015
• Study Completion: January 19, 2016
• Last Updated: January 26, 2021

Record last verified: 2021-01

Locations

US (1)