Ignite Creation Date:
2024-05-06 @ 2:58 AM
Last Modification Date:
2024-10-26 @ 11:26 AM
Study NCT ID:
NCT02167607
Status:
COMPLETED
Last Update Posted:
2021-01-28
First Post:
2014-06-17
Brief Title:
A Pilot Study to Characterize the Bioavailability and Plasma Profile of Potato Polyphenols in Humans
Sponsor:
Clinical Nutrition Research Center Illinois Institute of Technology
Organization:
Clinical Nutrition Research Center Illinois Institute of Technology
Study Overview
Official Title:
A Pilot Study to Characterize the Bioavailability and Plasma Profile of Potato Polyphenols in Humans
Status:
COMPLETED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PPT
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
Secondary objective is to assess the influence of potatoes bioavailability and kinetic profiles on markers of chronic diseases
Detailed Description:
The proposed study is a single-center placebo-controlled randomized 2-arm 2-sequence crossover study that characterizes the bioavailability and kinetic profile of potatoes over 6-hour postprandial day PPD
A planned sample size of 12 will be enrolled into the study This study will require one initial screening visit pre-study visit and 2 PPDs This study will take 3-6 weeks per subject to complete
The trial will initiate with a screening visit which will last for about 1-15 hours where the subjects height weight waist circumference fasting blood glucose fasting hs-CRP high sensitivity C-reactive protein concentration blood pressure and heart rate will be measured and a survey related to general eating health and exercise habits will be completed
If willing and eligible to participate a 3-day food record 2 weekdays and 1 weekend will be given at the screening visit and collected on the following pre-study Visit to assess subjects baseline dietary intake and pattern Also subjects will be instructed to follow a relatively low polyphenolic-diet at least 7 days prior to the first PPD and for the duration of the study Prior to each PPD a dinner meal will be provided the day before the PPD to control the second meal effect from food and beverage intake of the night before the PPD
Subjects will arrive at the center in a fasting state for at least 10 hours well hydrated and rested Each PPD will require blood draws throughout the visit After evaluation of subjects health status via anthropometric vital sign and blood glucose measurements and in-person interview a registered nurse will place a catheter in subjects arm for the purpose of multiple blood sample collections and take the initial blood draw at fasting A standard high carbohydrate and high fat test meal with either 200g white potato or 200g purple potato will be served Thereafter timers will be started and blood sample will be collected at 20 40 60 120 180 240 300 and 360 minutes for assessment in plasma bioavailability and kinetic profile of potato polyphenols and changes in inflammation markers and relative metabolic indices The sequence of receiving the potato treatment at each visit will be randomly assigned based on computer generated sequences white potato-purple potato or purple potato-white potato
Premenopausal female subjects will be studied during the follicular phase of their menstrual cycle because food intake tends to be more stable during the follicular phase days 1-13 than during the luteal phase days 14-28 when the rise in progesterone levels decrease satiety and often resulting in increased intake Both PPD visits will be placed at least 3 days apart as well
A planned sample size of 12 will be enrolled into the study This study will require one initial screening visit pre-study visit and 2 PPDs This study will take 3-6 weeks per subject to complete
The trial will initiate with a screening visit which will last for about 1-15 hours where the subjects height weight waist circumference fasting blood glucose fasting hs-CRP high sensitivity C-reactive protein concentration blood pressure and heart rate will be measured and a survey related to general eating health and exercise habits will be completed
If willing and eligible to participate a 3-day food record 2 weekdays and 1 weekend will be given at the screening visit and collected on the following pre-study Visit to assess subjects baseline dietary intake and pattern Also subjects will be instructed to follow a relatively low polyphenolic-diet at least 7 days prior to the first PPD and for the duration of the study Prior to each PPD a dinner meal will be provided the day before the PPD to control the second meal effect from food and beverage intake of the night before the PPD
Subjects will arrive at the center in a fasting state for at least 10 hours well hydrated and rested Each PPD will require blood draws throughout the visit After evaluation of subjects health status via anthropometric vital sign and blood glucose measurements and in-person interview a registered nurse will place a catheter in subjects arm for the purpose of multiple blood sample collections and take the initial blood draw at fasting A standard high carbohydrate and high fat test meal with either 200g white potato or 200g purple potato will be served Thereafter timers will be started and blood sample will be collected at 20 40 60 120 180 240 300 and 360 minutes for assessment in plasma bioavailability and kinetic profile of potato polyphenols and changes in inflammation markers and relative metabolic indices The sequence of receiving the potato treatment at each visit will be randomly assigned based on computer generated sequences white potato-purple potato or purple potato-white potato
Premenopausal female subjects will be studied during the follicular phase of their menstrual cycle because food intake tends to be more stable during the follicular phase days 1-13 than during the luteal phase days 14-28 when the rise in progesterone levels decrease satiety and often resulting in increased intake Both PPD visits will be placed at least 3 days apart as well
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None