Skip to main content
OpenTrials
Completed

NCT Number: NCT04182971

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IIT (Illinois Institute of Technology), Center for Nutrition Research, Institute for Food Safety and Health

Chicago, Illinois, 60661, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fruit

Other

Phase 1 is 227g of orange fruit, Phase 2 is 230g of apple fruit

Fruit juice

Other

Phase 1 is 250g of orange juice, Phase 2 is 235g of apple juice

Fruit juice plus fiber

Other

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 outcomes

  1. Glucose

    Time frame: 0-120 minutes

    Cmax, plasma

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

PepsiCo Global R&D

Industry

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 2, 2019
Registry last updated
Dec 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.