CClinicalTrials.gg
CompletedNCT03685201PORUpdated Jul 14, 2020

Postprandial Glycemia in Orange Products

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

Phase
Not applicable
Study type
Interventional
Enrollment
43
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
All
01

Study 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.

Read the 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 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.

02

Conditions studied

  • Healthy

Keywords

  • orange pomace fiber
  • glycemic response
  • Orange
03

In context

Lead sponsor

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.

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

    • Subject is a male or female, 20-45 years of age, inclusive.

      • Subject has a BMI of 20.0-24.9 kg/m2, inclusive and weight ≥ 110 lb. at screening visit.
      • Subject is willing to maintain his/her usual physical activity pattern throughout the study period.
      • Subject is willing to follow study instructions including compliance with dietary restrictions, consumption of study beverage, and study visit schedule.
      • Subject is judged to be in good health on the basis of the medical history.
      • Subject is willing to abstain from alcohol consumption for 24 hours prior to study visit.
      • Exercise to be maintained throughout study duration, including 3 days before study visit
      • Subject is willing to maintain stable dose of current vitamins, minerals, supplements and medications not interfering with study outcomes, including birth control, throughout study duration.
      • Subject understands the study procedures and signs forms documenting informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator/s and is willing to complete study procedures

Exclusion criteria

Exclusion Criteria:

  • •Subject has fasting finger prick glucose >100 mg/dL.

    • Subject has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg) at the screening visit.
    • Subject has had major trauma or a surgical event within 2 months of study visit 1.
    • Subject has had a weight change ≥4.5 kg within 2 months of visit, taking weight loss drugs, or has had bariatric surgery or other weight reduction surgery (ie. liposuction, laser fat removal, etc)
    • Subject has a history or presence of clinically important endocrine, cardiovascular (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), pulmonary, biliary, or gastrointestinal disorders that, in the opinion of the Investigator, could interfere with the interpretation of the study results.
    • Subject has a history or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.
    • Subject has a history of extreme dietary habits, as judged by the Investigator (e.g., Atkins diet, etc.).
    • Subject has a history of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional.
    • Subject has a known intolerance or sensitivity to any ingredients in the study products.
    • Subject has used medications known to influence carbohydrate metabolism, including, but not limited to adrenergic blockers, diuretics, hypoglycemic medications, and systemic corticosteroids 2 weeks prior to visit 1 and throughout the study.
    • Subject taking systemic steroids, extreme alcohol use, or drug user.
    • Subject has vein access score less than 7
    • Subject is a female, who is pregnant, planning to be pregnant during the study period or lactating.
    • Subject is a current smoker. Past smoker abstinence for less than 2 years.
    • Subject has participated in any clinical trial within 30d prior to enrollment.
    • No participation in another Sponsored protocol within 6 months prior to enrollment
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
43 participants (actual)

Study arms

  • Active comparator
    Orange Juice1

    100% orange juice

    Dietary Supplement: Orange Juice1

  • Experimental
    Orange Juice2

    100% Orange Juice with enzyme-treated orange pomace fiber

    Dietary Supplement: Orange Juice2

  • Placebo comparator
    Raw Orange

    raw orange

    Dietary Supplement: Raw Orange

Interventions

  • Dietary supplementOrange Juice1

    100% Orange Juice

  • Dietary supplementOrange Juice2

    100% Orange Juice with enzyme-treated orange pomace fiber

  • Dietary supplementRaw Orange

    Raw Orange

06

What researchers measure

Primary outcomes

  1. Plasma Glucose maximal concentration (Cmax) over 2 hours

    Plasma Glucose maximal concentration (Cmax) over 2 hours

    Time frame: Postprandial 2 hours

Secondary outcomes

  1. 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

Other outcomes

  1. 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

  2. Plasma Insulin Cmax over 2 hours

    Plasma Insulin Cmax over 2 hours

    Time frame: Postprandial 2 hours

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

07

Study locations

1 site
  • Clinical Nutrition Research Center
    Chicago, Illinois 60616, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 14, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03685201
Lead sponsor
Clinical Nutrition Research Center, Illinois Institute of Technology
Responsible party
Sponsor
First posted
Sep 26, 2018
Start date
Sep 13, 2018
Primary completion
Nov 24, 2019
Completion
Nov 24, 2019
Last update
Jul 14, 2020

Study contacts

Britt Burton-Freeman, Ph.D
principal investigator · Illinois Institute of Technology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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