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The Impact of Fruit Juice, Fruit Juice With Pomace, or Whole Fruit on Glycemic Response | Clinical Trials | Clareo Health

COMPLETEDNA

The Impact of Fruit Juice, Fruit Juice With Pomace, or Whole Fruit on Glycemic Response

A Randomized, Crossover Study to Assess the Impact of Fruit Juice, Fruit Juice With Pomace, or Whole Fruit on Glycemic Response

NCT04369716•PepsiCo Global R&D

View on ClinicalTrials.gov

Summary

The primary aim of this clinical trial is to compare the effects of a whole orange, orange juice alone, and orange juice with pomace, and a whole apple, apple juice alone, apple juice with pomace on glycemic response. Fruit pomace is a fiber-rich byproduct that is isolated during normal juice production of fruits, such as orange and apple.

Detailed Description

Study products are matched on total sugar and fiber. Phase I consists of 3 orange study products and Phase II consists of 3 apple study products. Subjects consume one fruit test portion or beverage test portion per visit day with at least a 3 day washout in between. 24 hr diet records are reviewed each test day to verify food and drink consistency and a diet containing at least 150 g of carbohydrate. Subjects arrive fasted (10-14 h, water only), are asked to maintain adequate hydration; and refrain from vigorous physical activity (24 h), alcohol consumption (24 h), and tobacco products (for at least 1 h).

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Subject is a generally healthy male or female, 18-65 years of age, inclusive.
•2. Subject has a BMI of 18.5 to 29.9 kg/m2, inclusive, at Visit 1.
•3. Subject has a rating of 7 to 10 on the Vein Access Scale at Visit 1.
•4. If a smoker, subject has no plans to change smoking habits during the study period and is able to abstain from tobacco products at least 1 h prior to and during each test visit
•5. Subject is on a stable dose of vitamins, minerals, and other supplements throughout the trial and is willing to maintain the current use throughout the trial. On test days, subject agrees not to take any vitamins, minerals, or other dietary supplements until dismissal from the clinic. Failure to comply will result in a rescheduled test visit.
•6. If a female on oral contraceptives, the subject must be on a stable dose of oral contraceptives \[defined as same dose for the past 90 d
•7. If applicable, subject must be on a stable dose of.osteoporosis medication, anti-hypertensive medication, aspirin, and/or thyroid medication.
•8. Subject is normally active and judged by the Investigator to be in general good health on the basis of medical history.
•9. Subject is willing to maintain physical activity patterns, body weight, and habitual diet throughout the trial.
•10. Subject is willing to abstain from alcohol consumption and avoid vigorous physical activity for 24 h prior to and during test visits.
+2 more criteria

Exclusion Criteria

•1. Subject has diagnosed diabetes mellitus (Type 1 or Type 2) or fasting glucose ≥110 mg/dL at Visit 1. No retest allowed.
•2. Subject has the presence of a gastrointestinal disease or condition that could potentially interfere with absorption of the study product (including but not limited to inflammatory bowel diseases, ulcers), including history of gastrointestinal surgery (e.g., for weight reduction).
•3. Subject has a history or presence of clinically important endocrine, cardiovascular (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), pulmonary (including uncontrolled asthma), hepatic, renal, hematologic, immunologic, neurologic (such as Alzheimer's or Parkinson's disease), or biliary disorders, in the opinion of the Clinical Investigator.
•4. Subject has a history of bariatric surgery.
•5. Subject has extreme dietary habits (e.g., Atkins diet, very high protein, vegetarian), in the opinion of the Clinical Investigator.
•6. Subject has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg) as defined by the blood pressure measured at Visit 1. One retest will be allowed.
•7. Subject has a history or presence of cancer in the prior two years, except for non-melanoma skin cancer.
•8. Subject has experienced any major trauma or any other surgical event within three months
•9. Subject has a known allergy, intolerances, or sensitivity to any of the ingredients in the study products.
•10. Subject has had a weight loss or gain \>4.5 kg in the 3 months prior to Visit 1.
+7 more criteria

Locations (1)

BioFortis Innovation Services

Addison, Illinois, United States

Key Dates

Start Date

October 9, 2017

Primary Completion Date

December 23, 2017

Completion Date

December 23, 2017

Last Updated

May 1, 2020

Enrollment

ACTUAL participants

Conditions

Glycemic Response

Interventions

Whole oranges

OTHER

Whole Apples

OTHER

Orange juice + orange pomace

OTHER

Apple juice + apple pomace

OTHER

Orange juice

OTHER

Apple juice

OTHER

PRediction Of Glycemic RESponse Study

NCT04881019

Glycemic Response

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COMPLETEDNA

Short, Simple, Exercise to Improve Circadian Dependent Postprandial Glycemic Responses

NCT05783752

Postprandial Glycemic ResponsePostprandial Hyperglycemia+1 more

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COMPLETED

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 1, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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The Impact of Fruit Juice, Fruit Juice With Pomace, or Whole Fruit on Glycemic Response

Inclusion Criteria

Exclusion Criteria

PRediction Of Glycemic RESponse Study

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