Glycemic IndexNCT04182971
Effect of Added Fruit Pomace Fiber, Juice, and Whole Fruit on Postprandial Glycemia
A study testing Fruit, Fruit juice and Fruit juice plus fiber in people with Glycemic Index, run by PepsiCo Global R&D at 1 site in United States.
Trial summary
Compare the effects of whole orange, orange juice alone, and orange juice with added orange pomace fiber, and whole apple, apple juice alone, and apple juice with added apple pomace fiber, on 2h glycemic response. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Glycemic Index
- What is being tested?
- Fruit, Fruit juice and Fruit juice plus fiber
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2018to 3 Sep 2019
- 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 20-24.9 kg/m2 and weight >=110 lbs at screening
- Willing to maintain usual physical activity pattern and exercise level
- Willing to follow instructions for compliance with dietary restrictions, dosing and visits
- In good health based on medical history
- Willing to avoid alcohol for 24 hrs prior to visits
- Willing to maintain stable dose of vitamins, minerals, supplements, and medications not interfering with study outcomes including birth control for the study
- Understands procedures, signs informed consent and authorization for release of relevant protected health information and is willing to complete study procedures
Who cannot join
- Fasting finger stick glucose >100
- Uncontrolled hypertension
- Major trauma or surgical event within 2 months of Visit 1
- Weight change > 4.5 kg within 2 months, taking weight loss drugs, bariatric surgery, or other weight reduction surgery (liposuction, laser fat removal, etc.)
- History or presence of clinically important endocrine, cardiovascular, pulmonary, bilary or gastrointestinal disorders that could interfere with the interpretation of study results
- History or presence of cancer in past 2 yrs except for non-melanoma skin cancer
Show all 15Show fewer
- History of extreme dietary habits (Atkins, etc.)
- History of eating disorder
- Known intolerance or sensitivity to any of the ingredients in the study products
- Subject has used medications know to influence carbohydrate metaboism 2 weeks prior to visit and throughout the study
- Subject is taking systemic steroids, extreme alcohol use or drug user
- Vein access score < 7
- Pregnant, planning to become pregnant, or lactating
- Current smoker or smoked within past 2 yrs
- Has not participated in another clinical trial for past 30 days or another PepsiCo study in past 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
IIT (Illinois Institute of Technology), Center for Nutrition Research, Institute for Food Safety and Health
Chicago, Illinois, 60661
About this study
Compare the effects of whole orange, orange juice alone, and orange juice with added orange pomace fiber, and whole apple, apple juice alone, and apple juice with added apple pomace fiber, on 2h glycemic response.
- Conditions
- Glycemic Index
- Being tested
- Fruit, Fruit juice, Fruit juice plus fiber
- Keywords
- Juice, Fiber
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FruitOther
Phase 1 is 227g of orange fruit, Phase 2 is 230g of apple fruit
Fruit juiceOther
Phase 1 is 250g of orange juice, Phase 2 is 235g of apple juice
Fruit juice plus fiberOther
Phase 1 is 157g of orange juice + 100g of orange pomace fiber (39% pomace by weight), Phase 2 is 129g of apple juice + 106g of apple pomace fiber (45% pomace by weight)
| Study group | Role | What they receive |
|---|---|---|
| Whole fruit | Active comparator | Phase 1 of study is an orange, Phase 2 of study is an apple Receives: Other: Fruit |
| Juice | Active comparator | Phase 1 of study is orange juice, Phase 2 of study is apple juice Receives: Other: Fruit juice |
| Juice plus pomace fiber | Experimental | Phase 1 is orange juice with added fiber, Phase 2 is apple juice with added fiber Receives: Other: Fruit juice plus fiber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose
Cmax, plasma
Measured: 0-120 minutes
Secondary outcomes (5)
Glucose
iAUC, plasma
Measured: 0-120 minutes
Insulin
iAUC, plasma
Measured: 0-120 minutes
Glucose
Tmax, plasma
Measured: 0-120 minutes
Insulin
Cmax, plasma
Measured: 0-120 minutes
Insulin
Tmax, plasma
Measured: 0-120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2019
- Study start28 Aug 2018
- Primary completion3 Sep 2019
- Study completion3 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glycemic IndexStudies 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
- Cross-over
- Masking
- None (open label)
- Enrolment
- 58 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
- NCT04182971
- Sponsor's protocol ID
- PEP-1806
- Status last verified
- Dec 2019
- First submitted
- 27 Nov 2019
- Last updated
- 5 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: After publication, investigator can be contacted to discuss requests.
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Added Fruit Pomace Fiber, Juice, and Whole Fruit on Postprandial Glycemia
- ClinicalTrials.gov ID
- NCT04182971
- Acronym / sponsor ID
- PEP-1806
- Conditions
- Glycemic Index
- Keywords
- Juice, Fiber
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Study start
- 28 Aug 2018 (actual)
- Primary completion
- 3 Sep 2019 (actual)
- Study completion
- 3 Sep 2019 (actual)
- First posted
- 2 Dec 2019 (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.
Compare the effects of whole orange, orange juice alone, and orange juice with added orange pomace fiber, and whole apple, apple juice alone, and apple juice with added apple pomace fiber, on 2h glycemic response.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Cross-over
| Arm | Type | Receives |
|---|---|---|
| Whole fruit | Active comparator | Other: FruitPhase 1 of study is an orange, Phase 2 of study is an apple |
| Juice | Active comparator | Other: Fruit juicePhase 1 of study is orange juice, Phase 2 of study is apple juice |
| Juice plus pomace fiber | Experimental | Other: Fruit juice plus fiberPhase 1 is orange juice with added fiber, Phase 2 is apple juice with added fiber |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- BMI 20-24.9 kg/m2 and weight >=110 lbs at screening
- Willing to maintain usual physical activity pattern and exercise level
- Willing to follow instructions for compliance with dietary restrictions, dosing and visits
- In good health based on medical history
- Willing to avoid alcohol for 24 hrs prior to visits
Key exclusion criteria (15 listed)
- Fasting finger stick glucose >100
- Uncontrolled hypertension
- Major trauma or surgical event within 2 months of Visit 1
- Weight change > 4.5 kg within 2 months, taking weight loss drugs, bariatric surgery, or other weight reduction surgery (liposuction, laser fat removal, etc.)
- History or presence of clinically important endocrine, cardiovascular, pulmonary, bilary or gastrointestinal disorders that could interfere with the interpretation of study results
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 |
|---|---|---|
| FruitPhase 1 is 227g of orange fruit, Phase 2 is 230g of apple fruit | Other | Whole fruit |
| Fruit juicePhase 1 is 250g of orange juice, Phase 2 is 235g of apple juice | Other | Juice |
| Fruit juice plus fiberPhase 1 is 157g of orange juice + 100g of orange pomace fiber (39% pomace by weight), Phase 2 is 129g of apple juice + 106g of apple pomace fiber (45% pomace by weight) | Other | Juice plus pomace fiber |
Primary outcome
Glucose
Time frame: 0-120 minutes
Cmax, plasma
5 secondary outcomes
Glucose
Time frame: 0-120 minutes
Insulin
Time frame: 0-120 minutes
Glucose
Time frame: 0-120 minutes
Insulin
Time frame: 0-120 minutes
Insulin
Time frame: 0-120 minutes
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 5 Dec 2019.
- Individual participant dataSharing planned: Undecided. After publication, investigator can be contacted to discuss requests.
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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.
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 Fruit, Fruit juice and Fruit juice plus fiber in people with Glycemic Index, 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 7 inclusion and 15 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 5 Dec 2019. 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?
Glucose (time frame: 0-120 minutes). 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 5 Dec 2019.