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

Glycemic Index Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04182971
• Other study ID #: PEP-1806
• Status: Completed
• Phase: N/A
• Start date: August 28, 2018
• Est. completion date: September 3, 2019

Study information

• Verified date: December 2019
• Source: PepsiCo Global R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: September 3, 2019
• Est. primary completion date: September 3, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Glycemic Index

Intervention

Other:
• Fruit
Phase 1 is 227g of orange fruit, Phase 2 is 230g of apple fruit
• Fruit juice
Phase 1 is 250g of orange juice, Phase 2 is 235g of apple juice
• 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)

Locations

Country	Name	City	State
United States	IIT (Illinois Institute of Technology), Center for Nutrition Research, Institute for Food Safety and Health	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
PepsiCo Global R&D

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose	Cmax, plasma	0-120 minutes
Secondary	Glucose	iAUC, plasma	0-120 minutes
Secondary	Insulin	iAUC, plasma	0-120 minutes
Secondary	Glucose	Tmax, plasma	0-120 minutes
Secondary	Insulin	Cmax, plasma	0-120 minutes
Secondary	Insulin	Tmax, plasma	0-120 minutes