Clinical trial NCT04182971: Effect of Added Fruit Pomace Fiber, Juice, and Whole Fruit on Postprandial Glycemia
Official title: Effect of Added Fruit Pomace Fiber, Juice, and Whole Fruit on Postprandial Glycemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glycemic Index
Keywords: Juice
Fiber
Lead sponsor: PepsiCo Global R&D
Sponsor class: INDUSTRY
First posted: 2019-12-02
Enrollment: 58
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Cross-over
Primary purpose: BASIC_SCIENCE

Brief summary: Compare the effects of whole orange, orange juice alone, and orange juice with added orange pomace fiber, and whole apple, apple juice alone, and apple juice with added apple pomace fiber, on 2h glycemic response.


Eligibility criteria: Inclusion Criteria:

* BMI 20-24.9 kg/m2 and weight \>=110 lbs at screening
* Willing to maintain usual physical activity pattern and exercise level
* Willing to follow instructions for compliance with dietary restrictions, dosing and visits
* In good health based on medical history
* Willing to avoid alcohol for 24 hrs prior to visits
* Willing to maintain stable dose of vitamins, minerals, supplements, and medications not interfering with study outcomes including birth control for the study
* Understands procedures, signs informed consent and authorization for release of relevant protected health information and is willing to complete study procedures

Exclusion Criteria:

* Fasting finger stick glucose \>100
* Uncontrolled hypertension
* Major trauma or surgical event within 2 months of Visit 1
* Weight change \> 4.5 kg within 2 months, taking weight loss drugs, bariatric surgery, or other weight reduction surgery (liposuction, laser fat removal, etc.)
* History or presence of clinically important endocrine, cardiovascular, pulmonary, bilary or gastrointestinal disorders that could interfere with the interpretation of study results
* History or presence of cancer in past 2 yrs except for non-melanoma skin cancer
* History of extreme dietary habits (Atkins, etc.)
* History of eating disorder
* Known intolerance or sensitivity to any of the ingredients in the study products
* Subject has used medications know to influence carbohydrate metaboism 2 weeks prior to visit and throughout the study
* Subject is taking systemic steroids, extreme alcohol use or drug user
* Vein access score \< 7
* Pregnant, planning to become pregnant, or lactating
* Current smoker or smoked within past 2 yrs
* Has not participated in another clinical trial for past 30 days or another PepsiCo study in past 6 months

Primary outcomes:
measure: Glucose
timeFrame: 0-120 minutes
Secondary outcomes:
measure: Glucose
timeFrame: 0-120 minutes
measure: Insulin
timeFrame: 0-120 minutes
measure: Glucose
timeFrame: 0-120 minutes
measure: Insulin
timeFrame: 0-120 minutes
measure: Insulin
timeFrame: 0-120 minutes
Other outcomes:
Locations:
city: Chicago
country: United States
facility: IIT (Illinois Institute of Technology), Center for Nutrition Research, Institute for Food Safety and Health
state: Illinois
Study officials:
References: