A Pilot Study to Characterize the Bioavailability and Plasma Profile of Potato Polyphenols in Humans

Completed · Not applicable · Has a placebo group

Conditions studied: Premenopausal Women, Overweight and Obese Women

In brief

Primary objective is to determine the bioavailability of and characterize the kinetic profile of target polyphenol metabolites of potatoes over 6 hour postprandial period. Secondary objective is to assess the influence of potatoes' bioavailability and kinetic profiles on markers of chronic diseases.

Key facts

Study ID

NCT02167607

Run by

Clinical Nutrition Research Center, Illinois Institute of Technology

People needed

13

Starts

2014-06-01

Expected to finish

2014-11-11

Last updated by the study team

2021-01-28

Who can join

Age: 20 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Premenopausal women with regular menstrual cycle
• Aged between 20 to 45 years old
• Body Mass Index (BMI) range from 25 to 35 kg/m2; exception BMI 23 to 35 kg/m2 for Asian population
• Fasting blood glucose concentration < 110 mg/dL
• Fasting hs-CRP >2 mg/dL to < 10 mg/dL
• Weight stable: not gained or lost weight +/- 5 lbs in previous 3 months
• Non-smokers
• 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, i.e. lipid lowering medications, anti-inflammatory drugs, fish oil, probiotics, grape seed supplement, etc…If anti-inflammation and/or antibiotic medications/supplements are taken, subjects may qualify if go off these medications/supplements 30 days wash-out before entering the study.
• Able to provide informed consent
• Able to comply and perform the procedures requested by the protocol

You may not qualify if…

• Men
• Past smokers: abstinence for less than 2 years
• Women who smoke
• Women with known or suspected food intolerance, allergies or hypersensitivity to the study materials or closely related compound or any their stated ingredients.
• Women known to have/diagnosed with diabetes mellitus
• Women who have fasting blood glucose concentrations ≥110 mg/dL
• Women who have uncontrolled blood pressure >140 mmHg/90 mmHg
• Women with documented vascular disease, e.g., heart failure, myocardial infarction, stroke, angina, related surgeries.
• Women with cancer other than non-melanoma skin cancer in previous 5 years.
• Women who are taking medication or dietary supplements that may interfere with the outcomes of the study; e.g., antioxidant supplements, anti-inflammation, lipid lowering medication. Subjects may choose to go off dietary supplements (requires 30 days washout).
• Women who are taking blood pressure lowering medication that may interfere the outcomes of the study; e.g. diuretics.
• 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.
• Women who are vegetarians or vegans
• Substance (alcohol or drug) abuse within the last 2 years.
• Excessive coffee and tea consumers (> 4 cups/day); berry and grape consumers (>2 cups/day)
• Women who do excessive exercise regularly or athlete
• Unstable weight: gained or lost weight +/- 5 lbs in previous 3 months
• Women who are known to be pregnant or who are intending to become pregnant over the course of the study
• Women who are lactating

Where it is running

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

Full record on ClinicalTrials.gov

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