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

Not Applicable

Completed

• Conditions: Glycemic Index
• Interventions: Other: Fruit juice; Other: Fruit juice plus fiber; Other: Fruit

• Registration Number: NCT04182971
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-28
• Primary Completion: 2019-09-03
• Study Completion: 2019-09-03
• Study First Submitted: 2019-11-27
• Study First Submitted QC: 2019-11-27
• Status Verified: 2019-12
• Study First Posted: 2019-12-02
• Last Update Submitted: 2019-12-03
• Last Update Posted: 2019-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Juice	Fruit juice	Phase 1 of study is orange juice, Phase 2 of study is apple juice
Juice plus pomace fiber	Fruit juice plus fiber	Phase 1 is orange juice with added fiber, Phase 2 is apple juice with added fiber
Whole fruit	Fruit	Phase 1 of study is an orange, Phase 2 of study is an apple

Primary Outcome Measures

Name	Time	Method
Glucose	0-120 minutes	Cmax, plasma

Secondary Outcome Measures

Name	Time	Method
Insulin	0-120 minutes	Tmax, plasma
Glucose	0-120 minutes	Tmax, plasma

Trial Locations

Locations (1)

IIT (Illinois Institute of Technology), Center for Nutrition Research, Institute for Food Safety and Health; 🇺🇸 Chicago, Illinois, United States