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

PepsiCo Global R&D1 site in 1 country18 target enrollmentOctober 9, 2017

ConditionsGlycemic Response

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Glycemic Response
Sponsor: PepsiCo Global R&D
Enrollment: 18
Locations: 1
Primary Endpoint: Positive incremental area under the curve (iAUC) for blood glucose
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

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).

Registry

clinicaltrials.gov

Start Date

October 9, 2017

End Date

December 23, 2017

Last Updated

6 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

PepsiCo Global R&D

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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
•Subject has a rating of 7 to 10 on the Vein Access Scale at Visit
•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.

Exclusion Criteria

•Subject has diagnosed diabetes mellitus (Type 1 or Type 2) or fasting glucose ≥110 mg/dL at Visit
•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
•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

Outcomes

Primary Outcomes

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 Outcomes

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)
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 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)