Maximum Observed Plasma Glucose Concentration (Cmax)POGRNCT02112851
Processed Orange and the Glycemic Response
A study testing Orange flavored beverage in people with Maximum Observed Plasma Glucose Concentration (Cmax), run by PepsiCo Global R&D at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Maximum Observed Plasma Glucose Concentration (Cmax)
- What is being tested?
- Orange flavored beverage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2014to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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])
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- Orange flavored beverage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orange flavored beverageOther
Intervention involves consumption of one beverage of 240ml following baseline measurements
| Study group | Role | What they receive |
|---|---|---|
| Orange flavored beverage | Placebo comparator | 240ml orange beverage Receives: Other: Orange flavored beverage |
| Orange flavored beverage - Test1 | Experimental | 240ml processed whole orange low dose Receives: Other: Orange flavored beverage |
| Orange flavored beverage - Test2 | Experimental | 240ml processed whole orange high dose Receives: Other: Orange flavored beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma glucose concentration (Cmax)
Measured: 0-8 hours
Secondary outcomes (2)
Maximum observed plasma insulin concentration (Cmax)
Measured: 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)
Measured: 0-8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2014 (estimated)
- Study start7 Mar 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maximum Observed Plasma Glucose Concentration (Cmax)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- PepsiCo Global R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02112851
- Sponsor's protocol ID
- PEP-1326
- Acronym
- POGR
- Status last verified
- Mar 2021
- First submitted
- 10 Apr 2014
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02112851
- Acronym / sponsor ID
- POGR / PEP-1326
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Study start
- 7 Mar 2014 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 14 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Orange flavored beverage | Placebo comparator | Other: Orange flavored beverage240ml orange beverage |
| Orange flavored beverage - Test1 | Experimental | Other: Orange flavored beverage240ml processed whole orange low dose |
| Orange flavored beverage - Test2 | Experimental | Other: Orange flavored beverage240ml processed whole orange high dose |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (32 listed)
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orange flavored beverageIntervention involves consumption of one beverage of 240ml following baseline measurements | Other | Orange flavored beverage, Orange flavored beverage - Test1, Orange flavored beverage - Test2 |
Primary outcome
Maximum observed plasma glucose concentration (Cmax)
Time frame: 0-8 hours
2 secondary outcomes
Maximum observed plasma insulin concentration (Cmax)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orange flavored beverage in people with Maximum Observed Plasma Glucose Concentration (Cmax), run by PepsiCo Global R&D at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum observed plasma glucose concentration (Cmax) (time frame: 0-8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2021.