An interventional study of Orange Juice1 and Orange Juice2 in Healthy, sponsored by Clinical Nutrition Research Center, Illinois Institute of Technology. Completed at 1 site in United States. Open to participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-14.
Sponsored by Clinical Nutrition Research Center, Illinois Institute of Technology · Not applicable, Interventional, and Basic science
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.
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 subject's health status (via anthropometric, vital sign and blood glucose measurements and in-person interview), a Licensed health Care Professional will place a catheter in subject's 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 data/sample collection for the day, the catheter will be removed and subjects will be evaluated for safety and/or discomfort/symptoms 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.
Clinical Nutrition Research Center, Illinois Institute of Technology is the lead sponsor of 59 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Subject is a male or female, 20-45 years of age, inclusive.
Exclusion Criteria:
•Subject has fasting finger prick glucose >100 mg/dL.
100% orange juice
Dietary Supplement: Orange Juice1
100% Orange Juice with enzyme-treated orange pomace fiber
Dietary Supplement: Orange Juice2
raw orange
Dietary Supplement: Raw Orange
100% Orange Juice
100% Orange Juice with enzyme-treated orange pomace fiber
Raw Orange
Plasma Glucose maximal concentration (Cmax) over 2 hours
Plasma Glucose maximal concentration (Cmax) over 2 hours
Time frame: Postprandial 2 hours
Changes in Plasma Glucose concentration as measured by incremental area under the curve (iAUC) over 2 hours
Changes in plasma glucose concentration as measured by iAUC over a 2 hour Postprandial Test day after administration of active treatment compared to control treatment
Time frame: Postprandial 2 hours
Time to plasma glucose maximal concentration (Tmax) over 2 hours
time to Plasma glucose maximal concentration (Tmax) over 2 hours
Time frame: Postprandial 2 hours
Plasma Insulin Cmax over 2 hours
Plasma Insulin Cmax over 2 hours
Time frame: Postprandial 2 hours
Changes in plasma insulin concentration as measured by iAUC over a 2 hour Postprandial Test day after administration of active treatment compared to control treatment
Plasma Insulin iAUC over 2 hours
Time frame: Postprandial 2 hours
time to to Plasma Insulin Maximal concentration (Tmax) over 2 hours
time to to Plasma Insulin Maximal concentration (Tmax) over 2 hours
Time frame: Postprandial 2 hours
Changes in postprandial subjective satiety responses using visual analog scales (VAS) of Hunger
Self-reported VAS of hunger ranged in 0 to 100 mm
Time frame: Postprandial 2 hours
Changes in postprandial subjective satiety responses using VAS of Fullness
Self-reported VAS of fullness ranged in 0 to 100 mm
Time frame: Postprandial 2 hours
Changes in postprandial subjective satiety responses using VAS of desire to eat
Self-reported VAS of Desire to eat ranged in 0 to 100 mm
Time frame: Postprandial 2 hours
Changes in postprandial subjective satiety responses using VAS of Prospective food intake
Self-reported VAS of Prospective food intake ranged in 0 to 100 mm
Time frame: Postprandial 2 hours
Plan to share: No
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This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Clinical Nutrition Research Center, Illinois Institute of Technology