Ignite Creation Date:
2024-05-06 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 12:54 PM
Study NCT ID:
NCT03685201
Status:
COMPLETED
Last Update Posted:
2020-07-14
First Post:
2018-09-20
Brief Title:
Postprandial Glycemia in Orange Products
Sponsor:
Clinical Nutrition Research Center Illinois Institute of Technology
Organization:
Clinical Nutrition Research Center Illinois Institute of Technology
Study Overview
Official Title:
Effect of Added Fruit Pomace Fiber and Whole Fruit on Postprandial Glycemia in Orange
Status:
COMPLETED
Status Verified Date:
2020-07
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:
POR
Brief Summary:
The primary objective of the study is to compare the effects of a whole orange orange juice alone and orange juice with pomace on 2 hr glycemic response as measured by maximal glucose concentration
Detailed Description:
This study is a randomized 3-arm within subject cross-over trial allowing for three acute evaluations of 100 orange juice 250 g 100 Orange Juice with enzyme-treated orange pomace fiber 157 g orange juice with 100 g orange pomace and raw orange 227 g edible portion of navel orange on glucose and insulin response in fifty-two healthy men and women aged 20-45 years
A planned sample size of 52 will be enrolled into the study This study will require one initial screening visit and 3 study visits This study will take approximately 3-4 weeks per subject to complete
The initial screening visit will take 2 hours and provide subject with the informed consent document and determine subject eligibility through anthropometric measurements body composition measurement vital signs fasting blood glucose test finger prick a vein access scale evaluation online 24-hr diet recall and completion of a survey relate to general eating health and exercise habits For women a pregnancy test will be conducted
If willing and eligible to participate subjects will be invited to participate in the study for 3 study days Eligible subjects will be instructed to follow a relatively low polyphenolic diet for at least 1 week prior the beginning of the study and continue for the duration of the study
Each Study Day visit will last about 3 hours The day before each of the 3 Study Day visits subjects will be asked to consume the same dinner meal and record on a food record At each Study Day visit subjects will arrive at the clinic after fasting for 10 to 12 hours and in a well-hydrated and well-rested state
Each study visit 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 Licensed health Care Professional will place a catheter in subjects arm for the purpose of multiple blood sample collections and take the initial blood draw in the fasting state Subjects will be randomized to receive one of study products based on randomized treatment sequences for 3 study visits immediately after fasting blood draw
Participants will come to the research site on 3 separate occasions separated by a washout period On each occasion 2 fasting blood samples will be obtained at 5 min intervals -5 0 minute min Subjects will then consume one of the 3 treatments Further blood samples will be taken at 15 25 30 35 40 45 60 75 90 105 and 120 min Self-reported visual analog scales VAS will be used to measure subject hunger fullness desire to eat and prospective food intake After completion of all study procedures and datasample collection for the day the catheter will be removed and subjects will be evaluated for safety andor discomfortsymptoms before leaving the study site They will be given a take-home snack and given written instructions in preparation for the next visit Study day visits will be scheduled at least 3 days apart but no more than 7 days
A planned sample size of 52 will be enrolled into the study This study will require one initial screening visit and 3 study visits This study will take approximately 3-4 weeks per subject to complete
The initial screening visit will take 2 hours and provide subject with the informed consent document and determine subject eligibility through anthropometric measurements body composition measurement vital signs fasting blood glucose test finger prick a vein access scale evaluation online 24-hr diet recall and completion of a survey relate to general eating health and exercise habits For women a pregnancy test will be conducted
If willing and eligible to participate subjects will be invited to participate in the study for 3 study days Eligible subjects will be instructed to follow a relatively low polyphenolic diet for at least 1 week prior the beginning of the study and continue for the duration of the study
Each Study Day visit will last about 3 hours The day before each of the 3 Study Day visits subjects will be asked to consume the same dinner meal and record on a food record At each Study Day visit subjects will arrive at the clinic after fasting for 10 to 12 hours and in a well-hydrated and well-rested state
Each study visit 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 Licensed health Care Professional will place a catheter in subjects arm for the purpose of multiple blood sample collections and take the initial blood draw in the fasting state Subjects will be randomized to receive one of study products based on randomized treatment sequences for 3 study visits immediately after fasting blood draw
Participants will come to the research site on 3 separate occasions separated by a washout period On each occasion 2 fasting blood samples will be obtained at 5 min intervals -5 0 minute min Subjects will then consume one of the 3 treatments Further blood samples will be taken at 15 25 30 35 40 45 60 75 90 105 and 120 min Self-reported visual analog scales VAS will be used to measure subject hunger fullness desire to eat and prospective food intake After completion of all study procedures and datasample collection for the day the catheter will be removed and subjects will be evaluated for safety andor discomfortsymptoms before leaving the study site They will be given a take-home snack and given written instructions in preparation for the next visit Study day visits will be scheduled at least 3 days apart but no more than 7 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None