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

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.

Study Overview

• Status: Completed
• Conditions: Glycemic Response
• Intervention / Treatment: Other: Whole oranges; Other: Whole Apples; Other: Orange juice + orange pomace; Other: Apple juice + apple pomace; Other: Orange juice; Other: Apple juice

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).

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Addison, Illinois, United States, 60101
      • Biofortis Innovation Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
iAUC0-120 min for insulin	Blood serum	t = -15, -5, 15, 30, 45, 60, 90, and 120 min where t = 0 min is the start of study product consumption
Maximum concentration (Cmax) for blood glucose	Blood serum	t = -15, -5, 15, 30, 45, 60, 90, and 120 min where t = 0 min is the start of study product consumption
Time to maximum concentration (tmax) for blood glucose	Blood serum	t = -15, -5, 15, 30, 45, 60, 90, and 120 min where t = 0 min is the start of study product consumption
Maximum concentration (Cmax) for insulin	Blood serum	t = -15, -5, 15, 30, 45, 60, 90, and 120 min where t = 0 min is the start of study product consumption
Time to maximum concentration (tmax) for insulin	Blood serum	t = -15, -5, 15, 30, 45, 60, 90, and 120 min where t = 0 min is the start of study product consumption

Collaborators and Investigators

• Sponsor: PepsiCo Global R&D
• Investigators: Principal Investigator: Andrea Lawless, MD, Biofortis Innovation Services

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2017
• Primary Completion (Actual): December 23, 2017
• Study Completion (Actual): December 23, 2017

Study Registration Dates

• First Submitted: April 27, 2020
• First Submitted That Met QC Criteria: April 27, 2020
• First Posted (Actual): April 30, 2020

Study Record Updates

• Last Update Posted (Actual): May 1, 2020
• Last Update Submitted That Met QC Criteria: April 29, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: fruit; postprandial glycemia; fiber; pomace
• Other Study ID Numbers: PEP-1709

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No