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

PepsiCo

Status: Completed

Conditions: Glycemic Index

Treatments: Other: Fruit juice plus fiber; Other: Fruit juice; Other: Fruit

Study type: Interventional

Funder types: Industry

Identifiers

NCT04182971

PEP-1806

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: All

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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58 participants in 3 patient groups

Whole fruit

Active Comparator group

Description:

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

Treatment:

Other: Fruit

Juice

Active Comparator group

Description:

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

Treatment:

Other: Fruit juice

Juice plus pomace fiber

Experimental group

Description:

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

Treatment:

Other: Fruit juice plus fiber