Glycemic ResponseNCT04369716
The Impact of Fruit Juice, Fruit Juice With Pomace, or Whole Fruit on Glycemic Response
A study testing Whole oranges, Whole Apples and Orange juice + orange pomace in people with Glycemic Response, run by PepsiCo Global R&D at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Glycemic Response
- What is being tested?
- Whole oranges, Whole Apples and Orange juice + orange pomace
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2017to 23 Dec 2017
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 1.
- Subject has a rating of 7 to 10 on the Vein Access Scale at Visit 1.
- 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
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- 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.
- Subject understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the Investigators.
- Subject has no health conditions that would prevent him/her from fulfilling the study requirements as judged by the Clinical Investigator on the basis of medical history and routine laboratory test results.
Who cannot join
- Subject has diagnosed diabetes mellitus (Type 1 or Type 2) or fasting glucose ≥110 mg/dL at Visit 1. 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 1. One retest will be allowed.
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- 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
- Subject has a known allergy, intolerances, or sensitivity to any of the ingredients in the study products.
- Subject has had a weight loss or gain >4.5 kg in the 3 months prior to Visit 1.
- Subject has any signs or symptoms of an active infection of clinical relevance (e.g., urinary tract or respiratory) within 5 d prior to any test visit. If an infection occurs during the study period, test visits should be rescheduled until all signs and symptoms have resolved (at the discretion of the Investigator) and any treatment (e.g., antibiotic therapy) has been completed at least 5 d prior to testing.
- Subject has a recent history of (within 12 months of Visit 1) or strong potential for alcohol or substance abuse. Alcohol abuse define as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1½ oz distilled spirits).
- Subject has used medications known to influence carbohydrate metabolism, including, but not limited to, protease inhibitors, antipsychotics, adrenergic receptor blockers, diuretics, anti-diabetic agents, and systemic corticosteroids, within 30 d of Visit 1.
- Subject has used weight-loss drugs (including over-the-counter medications and/or supplements) or programs within 30 d prior to Visit 1.
- Subject is a female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period. The method of contraception must be recorded in the source documentation.
- Subject has been exposed to any non-registered drug product within 30 days prior to Visit 1.
- Subject has a condition the Clinical Investigator believes would interfere with his ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results, or put the subject at undue risk.
Trial locations and contacts
1 site in 1 country.
United States1 site
BioFortis Innovation Services
Addison, Illinois, 60101
About this study
Official title: A Randomized, Crossover Study to Assess the Impact of Fruit Juice, Fruit Juice With Pomace, or Whole Fruit on Glycemic Response
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.
Read the 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).
- Conditions
- Glycemic Response
- Being tested
- Whole oranges, Whole Apples, Orange juice + orange pomace, Apple juice + apple pomace, Orange juice
- Keywords
- fiber, fruit, pomace, postprandial glycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole orangesOther
Navel oranges (227 g total)
Whole ApplesOther
Red Delicious apple with skin (230 g)
Orange juice + orange pomaceOther
Orange Juice (149 g) + orange pomace (100g) [40% pomace by weight]
Apple juice + apple pomaceOther
Apple Juice (129 g) + apple pomace (106 g) [45% pomace by weight]
Orange juiceOther
Orange Juice (250 g)
Apple juiceOther
Apple Juice (235 g)
| Study group | Role | What they receive |
|---|---|---|
| Whole fruit 1 | Active comparator | Oranges Receives: Other: Whole oranges |
| Whole fruit 2 | Active comparator | Apples Receives: Other: Whole Apples |
| Juice 1 + pomace | Experimental | Orange Juice + orange pomace Receives: Other: Orange juice + orange pomace |
| Juice 2 + pomace | Experimental | Apple Juice + apple pomace Receives: Other: Apple juice + apple pomace |
| Juice 1 alone | Active comparator | Orange Juice Receives: Other: Orange juice |
| Juice 2 alone | Active comparator | Apple Juice Receives: Other: Apple juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive incremental area under the curve (iAUC) for blood glucose
Blood serum
Measured: t = -15, -5, 15, 30, 45, 60, 90, and 120 min where t = 0 min is the start of study product consumption
Secondary outcomes (5)
iAUC0-120 min for insulin
Blood serum
Measured: 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 blood glucose
Blood serum
Measured: 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
Blood serum
Measured: 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
Blood serum
Measured: 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
Blood serum
Measured: t = -15, -5, 15, 30, 45, 60, 90, and 120 min where t = 0 min is the start of study product consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start9 Oct 2017
- Primary completion23 Dec 2017
- Study completion23 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glycemic ResponseStudies 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
- Model description
- Conducted in 2 separate phases (1 phase/fruit) with 3 visits/phase
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- PepsiCo Global R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrea Lawless, MD, Principal investigator, Biofortis Innovation Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04369716
- Sponsor's protocol ID
- PEP-1709
- Status last verified
- Apr 2020
- First submitted
- 27 Apr 2020
- Last updated
- 1 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Crossover Study to Assess the Impact of Fruit Juice, Fruit Juice With Pomace, or Whole Fruit on Glycemic Response
- ClinicalTrials.gov ID
- NCT04369716
- Acronym / sponsor ID
- PEP-1709
- Conditions
- Glycemic Response
- Keywords
- fiber, fruit, pomace, postprandial glycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Study start
- 9 Oct 2017 (actual)
- Primary completion
- 23 Dec 2017 (actual)
- Study completion
- 23 Dec 2017 (actual)
- First posted
- 30 Apr 2020 (actual)
- 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.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Conducted in 2 separate phases (1 phase/fruit) with 3 visits/phase
| Arm | Type | Receives |
|---|---|---|
| Whole fruit 1 | Active comparator | Other: Whole orangesOranges |
| Whole fruit 2 | Active comparator | Other: Whole ApplesApples |
| Juice 1 + pomace | Experimental | Other: Orange juice + orange pomaceOrange Juice + orange pomace |
| Juice 2 + pomace | Experimental | Other: Apple juice + apple pomaceApple Juice + apple pomace |
| Juice 1 alone | Active comparator | Other: Orange juiceOrange Juice |
| Juice 2 alone | Active comparator | Other: Apple juiceApple Juice |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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 1.
- Subject has a rating of 7 to 10 on the Vein Access Scale at Visit 1.
- 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.
Key exclusion criteria (17 listed)
- Subject has diagnosed diabetes mellitus (Type 1 or Type 2) or fasting glucose ≥110 mg/dL at Visit 1. 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.
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 |
|---|---|---|
| Whole orangesNavel oranges (227 g total) | Other | Whole fruit 1 |
| Whole ApplesRed Delicious apple with skin (230 g) | Other | Whole fruit 2 |
| Orange juice + orange pomaceOrange Juice (149 g) + orange pomace (100g) [40% pomace by weight] | Other | Juice 1 + pomace |
| Apple juice + apple pomaceApple Juice (129 g) + apple pomace (106 g) [45% pomace by weight] | Other | Juice 2 + pomace |
| Orange juiceOrange Juice (250 g) | Other | Juice 1 alone |
| Apple juiceApple Juice (235 g) | Other | Juice 2 alone |
Primary outcome
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
5 secondary outcomes
iAUC0-120 min for insulin
Time frame: 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 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
Time to maximum concentration (tmax) 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
Maximum concentration (Cmax) for insulin
Time frame: 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
Time frame: t = -15, -5, 15, 30, 45, 60, 90, and 120 min where t = 0 min is the start of study product consumption
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 1 May 2020.
- Individual participant dataSharing planned: No
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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.
Andrea Lawless, MD principal investigator
Biofortis Innovation Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole oranges, Whole Apples and Orange juice + orange pomace in people with Glycemic Response, 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 12 inclusion and 17 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 1 May 2020. 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. 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?
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). 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 1 May 2020.