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

NCT02167607 | Completed

• 1 other identifier: 2014-033
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Premenopausal Women; Overweight and Obese Women

Keywords

Purple Potatoes; Polyphenolics

Outcome Measures

Primary Outcomes (1)

• Changes in plasma polyphenol metabolite concentrations over 6 hours after white or purple potato consumption with a high carbohydrate and high fat meal.

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

  6 hours

Secondary Outcomes (1)

• Changes in metabolic and inflammation markers over 6 hours after white or purple potato consumption with a high carbohydrate and high fat meal.

  6 hours

Other Outcomes (1)

• Changes in oxidative stress markers over 6 hours after white or purple potato consumption with a high carbohydrate and high fat meal

  6 hours

Study Arms (2)

Purple Potato

ACTIVE COMPARATOR

Active Comparator

Dietary Supplement: Active Comparator

White Potato

PLACEBO COMPARATOR

Placebo Comparator

Dietary Supplement: Placebo Comparator

Interventions

Active Comparator DIETARY_SUPPLEMENT

Purple Potato

Also known as: Purple Potato

Purple Potato

Placebo Comparator DIETARY_SUPPLEMENT

Placebo Comparator

Also known as: White Potato

White Potato

Eligibility Criteria

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

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)

Sponsors & Collaborators

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

Study Sites (1)

Clinical Nutrition Research Center

Chicago, Illinois, 60616, United States

Location

MeSH Terms

Conditions

Overweight

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: October 27, 2014
• Study Completion: November 11, 2014
• Last Updated: January 28, 2021

Record last verified: 2021-01

Locations

US (1)