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

NCT04182971 | Completed

• 1 other identifier: PEP-1806
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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

Keywords

Juice; Fiber

Outcome Measures

Primary Outcomes (1)

• Glucose

  Cmax, plasma

  0-120 minutes

Secondary Outcomes (5)

• Glucose

  0-120 minutes

• Insulin

  0-120 minutes

• Glucose

  0-120 minutes

• Insulin

  0-120 minutes

• Insulin

  0-120 minutes

Study Arms (3)

Whole fruit

ACTIVE COMPARATOR

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

Other: Fruit

Juice

ACTIVE COMPARATOR

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

Other: Fruit juice

Juice plus pomace fiber

EXPERIMENTAL

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

Other: Fruit juice plus fiber

Interventions

Fruit OTHER

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

Whole fruit

Fruit juice OTHER

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

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)

Juice plus pomace fiber

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• PepsiCo Global R&D: lead

Study Sites (1)

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

Chicago, Illinois, 60661, United States

Location

MeSH Terms

Interventions

Fruit; Fruit and Vegetable Juices; Dietary Fiber

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Beverages; Dietary Carbohydrates; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Cross-over

Study Record Dates

• First Submitted: November 27, 2019
• First Posted: December 2, 2019
• Study Start: August 28, 2018
• Primary Completion: September 3, 2019
• Study Completion: September 3, 2019
• Last Updated: December 5, 2019

Record last verified: 2019-12

Locations

US (1)