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

NCT ID: NCT04182971

Last Updated: 2019-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-28
• Study Completion Date: 2019-09-03

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.

Conditions

Glycemic Index

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Whole fruit

Phase 1 of study is an orange, Phase 2 of study is an apple

Group Type: ACTIVE_COMPARATOR

Fruit

Intervention Type: OTHER

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

Juice

Phase 1 of study is orange juice, Phase 2 of study is apple juice

Group Type: ACTIVE_COMPARATOR

Fruit juice

Intervention Type: OTHER

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

Juice plus pomace fiber

Phase 1 is orange juice with added fiber, Phase 2 is apple juice with added fiber

Group Type: EXPERIMENTAL

Fruit juice plus fiber

Intervention Type: 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)

Interventions

Fruit

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

Intervention Type: OTHER

Fruit juice

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

Intervention Type: 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)

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

PepsiCo Global R&D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Chicago, Illinois, United States

Countries

United States

Other Identifiers

PEP-1806

Identifier Type: -

Identifier Source: org_study_id