Processed Orange and the Glycemic Response (POGR)

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: Completed
• Conditions: Maximum Observed Plasma Glucose Concentration (Cmax)
• Intervention / Treatment: Other: Orange flavored beverage

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: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
Maximum observed plasma glucose concentration (Cmax)	0-8 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximum observed plasma insulin concentration (Cmax)	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)	0-8 hours

Collaborators and Investigators

• Sponsor: PepsiCo Global R&D

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2014
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: April 10, 2014
• First Submitted That Met QC Criteria: April 10, 2014
• First Posted (Estimate): April 14, 2014

Study Record Updates

• Last Update Posted (Actual): March 10, 2021
• Last Update Submitted That Met QC Criteria: March 8, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: PEP-1326