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

NCT04369716 | Completed

• 1 other identifier: PEP-1709
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Glycemic Response

Keywords

fiber; fruit; pomace; postprandial glycemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• iAUC0-120 min for insulin

  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

  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

  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

  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

  t = -15, -5, 15, 30, 45, 60, 90, and 120 min where t = 0 min is the start of study product consumption

Study Arms (6)

Whole fruit 1

ACTIVE COMPARATOR

Oranges

Other: Whole oranges

Whole fruit 2

ACTIVE COMPARATOR

Apples

Other: Whole Apples

Juice 1 + pomace

EXPERIMENTAL

Orange Juice + orange pomace

Other: Orange juice + orange pomace

Juice 2 + pomace

EXPERIMENTAL

Apple Juice + apple pomace

Other: Apple juice + apple pomace

Juice 1 alone

ACTIVE COMPARATOR

Orange Juice

Other: Orange juice

Juice 2 alone

ACTIVE COMPARATOR

Apple Juice

Other: Apple juice

Interventions

Whole oranges OTHER

Navel oranges (227 g total)

Whole fruit 1

Whole Apples OTHER

Red Delicious apple with skin (230 g)

Whole fruit 2

Orange juice + orange pomace OTHER

Orange Juice (149 g) + orange pomace (100g) \[40% pomace by weight\]

Juice 1 + pomace

Apple juice + apple pomace OTHER

Apple Juice (129 g) + apple pomace (106 g) \[45% pomace by weight\]

Juice 2 + pomace

Orange juice OTHER

Orange Juice (250 g)

Juice 1 alone

Apple juice OTHER

Apple Juice (235 g)

Juice 2 alone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is a generally healthy male or female, 18-65 years of age, inclusive.
• Subject has a BMI of 18.5 to 29.9 kg/m2, inclusive, at Visit 1.
• Subject has a rating of 7 to 10 on the Vein Access Scale at Visit 1.
• 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
• 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.
• 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
• If applicable, subject must be on a stable dose of.osteoporosis medication, anti-hypertensive medication, aspirin, and/or thyroid medication.
• Subject is normally active and judged by the Investigator to be in general good health on the basis of medical history.
• Subject is willing to maintain physical activity patterns, body weight, and habitual diet throughout the trial.
• Subject is willing to abstain from alcohol consumption and avoid vigorous physical activity for 24 h prior to and during test visits.
• 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.
• 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.

You may not qualify if:

• Subject has diagnosed diabetes mellitus (Type 1 or Type 2) or fasting glucose ≥110 mg/dL at Visit 1. No retest allowed.
• 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).
• 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.
• Subject has a history of bariatric surgery.
• Subject has extreme dietary habits (e.g., Atkins diet, very high protein, vegetarian), in the opinion of the Clinical Investigator.
• 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.
• Subject has a history or presence of cancer in the prior two years, except for non-melanoma skin cancer.
• Subject has experienced any major trauma or any other surgical event within three months
• Subject has a known allergy, intolerances, or sensitivity to any of the ingredients in the study products.
• Subject has had a weight loss or gain \>4.5 kg in the 3 months prior to Visit 1.
• 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.
• 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).
• 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.
• Subject has used weight-loss drugs (including over-the-counter medications and/or supplements) or programs within 30 d prior to Visit 1.
• 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.

Sponsors & Collaborators

• PepsiCo Global R&D: lead

Study Sites (1)

BioFortis Innovation Services

Addison, Illinois, 60101, United States

Location

Study Officials

• Andrea Lawless, MD

  Biofortis Innovation Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Conducted in 2 separate phases (1 phase/fruit) with 3 visits/phase

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: April 30, 2020
• Study Start: October 9, 2017
• Primary Completion: December 23, 2017
• Study Completion: December 23, 2017
• Last Updated: May 1, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)