Processed Orange and the Glycemic Response (POGR)

March 8, 2021 updated by: PepsiCo Global R&D

A Randomized, Placebo-controlled, Double-blind, Crossover Trial to Investigate the Effects of Acute Processed Whole Orange Consumption on Postprandial Glycemic Responses in Healthy Men

Randomized, placebo controlled, double blind, postprandial crossover study in male subjects. 3 intervention arms, consisting of a control (Product A), a low dose processed whole orange (Product B) and a high dose processed whole orange (Product C), to determine the effect of the interventions on the primary endpoint of postprandial glycemia. Secondarily, plasma insulin concentrations will be quantified.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study design is a randomized, placebo controlled, double-blind, crossover. This trial will include 33 subjects randomized to receive products A, B or C [240 mL (255 g)]. Subjects will be randomly assigned to one of 6 sequences of 3 interventions. After the initial screening visit, subjects will visit the Clinical and Translational Research Center (CTRC) the Tufts Translational and Clinical Science Institute (CTSI) on three separate occasions. Following each intervention day there will be a two week wash out period.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Males (due to potential hormonal fluctuations in female subjects) aged 30-65 y
  • BMI: 25-29.9 kg/m2
  • Not diabetic [diagnosed or fasting glucose >7 mmol/L (126 mg/dL)] or suffer from other endocrine disorders
  • Not having suffered a myocardial infarction/stroke in the past 12 mo
  • Not suffering from renal or bowel disease or have a history of choleostatic liver or pancreatitis
  • Not on drug treatment for hyperlipidaemia, hypertension, inflammation or hypercoagulation
  • No history of alcohol misuse
  • Not planning or on a weight reducing regime
  • Not taking any fish oil, fatty acid or vitamin and mineral supplements
  • Non smokers

Exclusion Criteria:

  • Females
  • Use of medications known to affect lipid metabolism, i.e., hypolipidemic or cholesterol-lowering agents (e.g., Pravastatin, Simuvustatin)

  • Use of (>2x/wk) medication for inflammation or hypercoagulation

    • Anticoagulants (Warfarin)
    • Inflammation - NSAID's (Tiaprofenic acid, Sulindac, Ibuprofen), Corticosteroids (Betamethasone)
  • Regular use (>2x/wk) of any acid-lowering medications, laxatives or anti-diarrheal medications (prescription or over-the-counter [OTC])
  • Use of medications known or suspected to influence blood pressure, including beta-adrenergic blocking agents (oral or ocular) (e.g., Sotalol, Bisoprolol), beta-adrenergic drugs, calcium channel blocking agents (Amlodipine, Nicardipine), angiotensin converting enzyme (ACE) inhibitors (Captopril, Cilazapril), angiotensin receptor blocking agents (Valsartan), nitrates, diuretics (Chlortalidone), venlafaxine and sibutramine, decongestants or chloroquine
  • Systolic blood pressure >150 mmHg and/or diastolic blood pressure >95 mmHg
  • CVD including coronary artery disease, left ventricular hypertrophy, congestive heart failure, cerebrovascular disease, stroke, peripheral vascular disease or dysautonomia
  • Gastrointestinal diseases conditions or medications influencing gastrointestinal absorption including active peptic ulcer disease, treatment with acid-lowering drugs or inflammatory bowel disease
  • Renal or chronic kidney disease due to any condition, renovascular disease, history of nephrolithiasis or serum creatinine >1.5 mg/dL
  • Endocrine disorders including diabetes [fasting blood glucose >7 mmol/L (126 mg/dL) or current pharmacologic treatment for diabetes], untreated thyroid disease, adrenal disease, pheochromocytoma, parathyroid disease or hyperuricemia
  • Rheumatologic diseases including gout or inflammatory arthritis
  • Active treatment for cancer of any type (except basal cell carcinoma)<1 y
  • Regular use of oral steroids except topical OTC steroids
  • Regular use of any dietary supplements containing vitamins, minerals, herbal or other plant-based preparations, fish oil supplements (including cod liver oil) or homeopathic remedies. However, subjects who are willing to refrain from the use of these supplements for 1 mo prior to their initial visit (Visit 3) may be considered eligible.
  • Usual daily ethanol intake of>2 drinks (24 oz beer, 8 oz wine, 2 oz hard liquor)
  • Cigarette smoking and/or nicotine replacement use. However, subjects who have stopped using these products for 1 y prior to their initial visit (Visit 1) may be considered eligible.
  • Illicit drug use
  • Infrequent (<3/wk) or excessive (>3/d) number of regular bowel movements

  • Specific laboratory blood or urine analysis parameters of:

    • Creatinine > 1.5 mg/dL
    • Electrolytes, calcium, phosphorous - out of normal ranges
    • ALT and AST >1.5 nmol
    • Total bilirubin - above normal range
    • Triglycerides ≥300 mg/dL
    • Fasting glucose ≥126 mg/dL
    • CBC: HCT outside of normal NEL reference ranges at the discretion of the study physician
    • WBC, PLT - outside of normal NEL reference ranges Strict vegetarians
  • Those on or planning a weight reducing regime
  • Unable to consume study meals or products
  • Subjects with larger than 5 kg weight loss in the last 3 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Orange flavored beverage
240ml orange beverage
Other: Orange flavored beverage
Intervention involves consumption of one beverage of 240ml following baseline measurements
Experimental: Orange flavored beverage - Test1
240ml processed whole orange low dose
Other: Orange flavored beverage
Intervention involves consumption of one beverage of 240ml following baseline measurements
Experimental: Orange flavored beverage - Test2
240ml processed whole orange high dose
Other: Orange flavored beverage
Intervention involves consumption of one beverage of 240ml following baseline measurements

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Maximum observed plasma glucose concentration (Cmax)
Time Frame: 0-8 hours
0-8 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Maximum observed plasma insulin concentration (Cmax)
Time Frame: 0-8 hours
0-8 hours
Area under the curve (AUC) of glucose and insulin and the time to reach Cmax gluc (Tmax gluc) and Cmax ins (Tmax ins)
Time Frame: 0-8 hours
0-8 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
PepsiCo Global R&D

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 7, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 10, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PEP-1326

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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