Effect of Added Fruit Pomace Fiber, Juice, and Whole Fruit on Postprandial Glycemia

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 29, 2019

Interventions

  • Other: Fruit
    • Phase 1 is 227g of orange fruit, Phase 2 is 230g of apple fruit
  • Other: Fruit juice
    • Phase 1 is 250g of orange juice, Phase 2 is 235g of apple juice
  • Other: Fruit juice plus fiber
    • Phase 1 is 157g of orange juice + 100g of orange pomace fiber (39% pomace by weight), Phase 2 is 129g of apple juice + 106g of apple pomace fiber (45% pomace by weight)

Arms, Groups and Cohorts

  • Active Comparator: Whole fruit
    • Phase 1 of study is an orange, Phase 2 of study is an apple
  • Active Comparator: Juice
    • Phase 1 of study is orange juice, Phase 2 of study is apple juice
  • Experimental: Juice plus pomace fiber
    • Phase 1 is orange juice with added fiber, Phase 2 is apple juice with added fiber

Clinical Trial Outcome Measures

Primary Measures

  • Glucose
    • Time Frame: 0-120 min
    • Cmax, plasma

Secondary Measures

  • Glucose
    • Time Frame: 0-120 min
    • iAUC, plasma
  • Insulin
    • Time Frame: 0-120 min
    • iAUC, plasma
  • Glucose
    • Time Frame: 0-120 min
    • Tmax, plasma
  • Insulin
    • Time Frame: 0-120 min
    • Cmax, plasma
  • Insulin
    • Time Frame: 0-120 min
    • Tmax, plasma

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • PepsiCo Global R&D
  • Provider of Information About this Clinical Study
    • Sponsor

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