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

Study Overview
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Brief Summary
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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.

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

Conditions
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Glycemic Index

Intervention / Treatment
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* Other: Fruit
* Other: Fruit juice
* Other: Fruit juice plus fiber


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Cross-over
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Whole fruit<br>Phase 1 of study is an orange, Phase 2 of study is an apple | Other: Fruit<br>* Phase 1 is 227g of orange fruit, Phase 2 is 230g of apple fruit<br>|
| Active Comparator: Juice<br>Phase 1 of study is orange juice, Phase 2 of study is apple juice | Other: Fruit juice<br>* Phase 1 is 250g of orange juice, Phase 2 is 235g of apple juice<br>|
| Experimental: Juice plus pomace fiber<br>Phase 1 is orange juice with added fiber, Phase 2 is apple juice with added fiber | Other: Fruit juice plus fiber<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose | Cmax, plasma | 0-120 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose | iAUC, plasma | 0-120 minutes | 
| Insulin | iAUC, plasma | 0-120 minutes | 
| Glucose | Tmax, plasma | 0-120 minutes | 
| Insulin | Cmax, plasma | 0-120 minutes | 
| Insulin | Tmax, plasma | 0-120 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Juice, Fiber