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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04369716
Recruitment Status : Completed
First Posted : April 30, 2020
Last Update Posted : May 1, 2020
Sponsor:
Information provided by (Responsible Party):
PepsiCo Global R&D

Brief 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.

Condition or disease Intervention/treatment Phase
Glycemic Response Other: Whole oranges Other: Whole Apples Other: Orange juice + orange pomace Other: Apple juice + apple pomace Other: Orange juice Other: Apple juice Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Conducted in 2 separate phases (1 phase/fruit) with 3 visits/phase
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Randomized, Crossover Study to Assess the Impact of Fruit Juice, Fruit Juice With Pomace, or Whole Fruit on Glycemic Response
Actual Study Start Date : October 9, 2017
Actual Primary Completion Date : December 23, 2017
Actual Study Completion Date : December 23, 2017

Arm Intervention/treatment
Active Comparator: Whole fruit 1
Oranges
Other: Whole oranges
Navel oranges (227 g total)

Active Comparator: Whole fruit 2
Apples
Other: Whole Apples
Red Delicious apple with skin (230 g)

Experimental: Juice 1 + pomace
Orange Juice + orange pomace
Other: Orange juice + orange pomace
Orange Juice (149 g) + orange pomace (100g) [40% pomace by weight]

Experimental: Juice 2 + pomace
Apple Juice + apple pomace
Other: Apple juice + apple pomace
Apple Juice (129 g) + apple pomace (106 g) [45% pomace by weight]

Active Comparator: Juice 1 alone
Orange Juice
Other: Orange juice
Orange Juice (250 g)

Active Comparator: Juice 2 alone
Apple Juice
Other: Apple juice
Apple Juice (235 g)




Primary Outcome Measures :
  1. Positive incremental area under the curve (iAUC) for blood glucose [ Time Frame: t = -15, -5, 15, 30, 45, 60, 90, and 120 min where t = 0 min is the start of study product consumption ]
    Blood serum


Secondary Outcome Measures :
  1. iAUC0-120 min for insulin [ Time Frame: t = -15, -5, 15, 30, 45, 60, 90, and 120 min where t = 0 min is the start of study product consumption ]
    Blood serum

  2. Maximum concentration (Cmax) for blood glucose [ Time Frame: t = -15, -5, 15, 30, 45, 60, 90, and 120 min where t = 0 min is the start of study product consumption ]
    Blood serum

  3. Time to maximum concentration (tmax) for blood glucose [ Time Frame: t = -15, -5, 15, 30, 45, 60, 90, and 120 min where t = 0 min is the start of study product consumption ]
    Blood serum

  4. Maximum concentration (Cmax) for insulin [ Time Frame: t = -15, -5, 15, 30, 45, 60, 90, and 120 min where t = 0 min is the start of study product consumption ]
    Blood serum

  5. Time to maximum concentration (tmax) for insulin [ Time Frame: t = -15, -5, 15, 30, 45, 60, 90, and 120 min where t = 0 min is the start of study product consumption ]
    Blood serum



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  11. Subject understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the Investigators.
  12. Subject has no health conditions that would prevent him/her from fulfilling the study requirements as judged by the Clinical Investigator on the basis of medical history and routine laboratory test results.

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.
  11. Subject has any signs or symptoms of an active infection of clinical relevance (e.g., urinary tract or respiratory) within 5 d prior to any test visit. If an infection occurs during the study period, test visits should be rescheduled until all signs and symptoms have resolved (at the discretion of the Investigator) and any treatment (e.g., antibiotic therapy) has been completed at least 5 d prior to testing.
  12. Subject has a recent history of (within 12 months of Visit 1) or strong potential for alcohol or substance abuse. Alcohol abuse define as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1½ oz distilled spirits).
  13. Subject has used medications known to influence carbohydrate metabolism, including, but not limited to, protease inhibitors, antipsychotics, adrenergic receptor blockers, diuretics, anti-diabetic agents, and systemic corticosteroids, within 30 d of Visit 1.
  14. Subject has used weight-loss drugs (including over-the-counter medications and/or supplements) or programs within 30 d prior to Visit 1.
  15. Subject is a female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period. The method of contraception must be recorded in the source documentation.
  16. Subject has been exposed to any non-registered drug product within 30 days prior to Visit 1.
  17. Subject has a condition the Clinical Investigator believes would interfere with his ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results, or put the subject at undue risk.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04369716


Locations
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United States, Illinois
BioFortis Innovation Services
Addison, Illinois, United States, 60101
Sponsors and Collaborators
PepsiCo Global R&D
Investigators
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Principal Investigator: Andrea Lawless, MD Biofortis Innovation Services
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Responsible Party: PepsiCo Global R&D
ClinicalTrials.gov Identifier: NCT04369716    
Other Study ID Numbers: PEP-1709
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: May 1, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by PepsiCo Global R&D:
fiber
fruit
pomace
postprandial glycemia