Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04182971
Recruitment Status : Completed
First Posted : December 2, 2019
Last Update Posted : December 5, 2019
Sponsor:
Information provided by (Responsible Party):
PepsiCo Global R&D

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.

Condition or disease Intervention/treatment Phase
Glycemic Index Other: Fruit Other: Fruit juice Other: Fruit juice plus fiber Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Cross-over
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of Added Fruit Pomace Fiber, Juice, and Whole Fruit on Postprandial Glycemia
Actual Study Start Date : August 28, 2018
Actual Primary Completion Date : September 3, 2019
Actual Study Completion Date : September 3, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber

Arm Intervention/treatment
Active Comparator: Whole fruit
Phase 1 of study is an orange, Phase 2 of study is an apple
Other: Fruit
Phase 1 is 227g of orange fruit, Phase 2 is 230g of apple fruit

Active Comparator: Juice
Phase 1 of study is orange juice, Phase 2 of study is apple juice
Other: Fruit juice
Phase 1 is 250g of orange juice, Phase 2 is 235g of apple juice

Experimental: Juice plus pomace fiber
Phase 1 is orange juice with added fiber, Phase 2 is apple juice with added fiber
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)




Primary Outcome Measures :
  1. Glucose [ Time Frame: 0-120 minutes ]
    Cmax, plasma


Secondary Outcome Measures :
  1. Glucose [ Time Frame: 0-120 minutes ]
    iAUC, plasma

  2. Insulin [ Time Frame: 0-120 minutes ]
    iAUC, plasma

  3. Glucose [ Time Frame: 0-120 minutes ]
    Tmax, plasma

  4. Insulin [ Time Frame: 0-120 minutes ]
    Cmax, plasma

  5. Insulin [ Time Frame: 0-120 minutes ]
    Tmax, plasma



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04182971


Locations
Layout table for location information
United States, Illinois
IIT (Illinois Institute of Technology), Center for Nutrition Research, Institute for Food Safety and Health
Chicago, Illinois, United States, 60661
Sponsors and Collaborators
PepsiCo Global R&D

Layout table for additonal information
Responsible Party: PepsiCo Global R&D
ClinicalTrials.gov Identifier: NCT04182971     History of Changes
Other Study ID Numbers: PEP-1806
First Posted: December 2, 2019    Key Record Dates
Last Update Posted: December 5, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: After publication, investigator can be contacted to discuss requests.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by PepsiCo Global R&D:
Juice
Fiber