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

December 3, 2019 updated by: PepsiCo Global R&D
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60661
        • IIT (Illinois Institute of Technology), Center for Nutrition Research, Institute for Food Safety and Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucose
Time Frame: 0-120 minutes
Cmax, plasma
0-120 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucose
Time Frame: 0-120 minutes
iAUC, plasma
0-120 minutes
Insulin
Time Frame: 0-120 minutes
iAUC, plasma
0-120 minutes
Glucose
Time Frame: 0-120 minutes
Tmax, plasma
0-120 minutes
Insulin
Time Frame: 0-120 minutes
Cmax, plasma
0-120 minutes
Insulin
Time Frame: 0-120 minutes
Tmax, plasma
0-120 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PepsiCo Global R&D

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 28, 2018

Primary Completion (Actual)

September 3, 2019

Study Completion (Actual)

September 3, 2019

Study Registration Dates

First Submitted

November 27, 2019

First Submitted That Met QC Criteria

November 27, 2019

First Posted (Actual)

December 2, 2019

Study Record Updates

Last Update Posted (Actual)

December 5, 2019

Last Update Submitted That Met QC Criteria

December 3, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PEP-1806

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

After publication, investigator can be contacted to discuss requests.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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