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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04182971
Other study ID # PEP-1806
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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