POGR: Processed Orange and the Glycemic Response

Sponsor

PepsiCo Global R&D (Industry)

Overall Status

Completed

CT.gov ID

NCT02112851

Collaborator

(none)

Enrollment

Location

Arms

21.8

Actual Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Maximum Observed Plasma Glucose Concentration (Cmax)	Other: Orange flavored beverage	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

38 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Mar 7, 2014

Actual Primary Completion Date :

Jan 1, 2016

Actual Study Completion Date :

Jan 1, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Maximum observed plasma glucose concentration (Cmax) [0-8 hours]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 65 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tufts University	Boston	Massachusetts	United States	02111

Sponsors and Collaborators

PepsiCo Global R&D

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

PepsiCo Global R&D

ClinicalTrials.gov Identifier:

NCT02112851

Other Study ID Numbers:

PEP-1326

First Posted:

Apr 14, 2014

Last Update Posted:

Mar 10, 2021

Last Verified:

Mar 1, 2021

Study Results

No Results Posted as of Mar 10, 2021