HealthyPAPNCT03846986
Postprandial Glycemia in Apple Products
A study testing Apple Juice1, Apple Juice2 and Raw Apple in people with Healthy, run by Clinical Nutrition Research Center, Illinois Institute of Technology at 1 site in United States.
Trial summary
The primary objective of the study is to compare the effects of a whole apple, apple juice alone, and apple juice with pomace on 2 hr glycemic response as measured by maximal glucose concentration Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Apple Juice1, Apple Juice2 and Raw Apple
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2019to 12 Jun 2020
- 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
- • Subject is a male or female, 20-45 years of age, inclusive.
- Subject has a BMI of 20.0-24.9 kg/m2, inclusive and weight ≥ 110 lb at screening visit.
- Subject is willing to maintain his/her usual physical activity pattern throughout the study period.
- Subject is willing to follow study instructions including compliance with dietary restrictions, consumption of study beverage, and study visit schedule.
- Subject is judged to be in good health on the basis of the medical history.
- Subject is willing to abstain from alcohol consumption for 24 hours prior to study visit.
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- Exercise to be maintained throughout study duration, including 3 days before study visit
- Subject is willing to maintain stable dose of current vitamins, minerals, supplements and medications not interfering with study outcomes, including birth control, throughout study duration.
- Subject understands the study procedures and signs forms documenting informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator/s and is willing to complete study procedures
Who cannot join
- •Subject has fasting finger prick glucose >100 mg/dL.
- Subject has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg) at the screening visit.
- Subject has had major trauma or a surgical event within 2 months of study visit 1.
- Subject has had a weight change ≥4.5 kg within 2 months of visit, taking weight loss drugs, or has had bariatric surgery or other weight reduction surgery (ie. liposuction, laser fat removal, etc)
- 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, biliary, or gastrointestinal disorders that, in the opinion of the Investigator, could interfere with the interpretation of the study results.
- Subject has a history or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.
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- Subject has a history of extreme dietary habits, as judged by the Investigator (e.g., Atkins diet, etc.).
- Subject has a history of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional.
- Subject has a known intolerance or sensitivity to any ingredients in the study products.
- Subject has used medications known to influence carbohydrate metabolism, including, but not limited to adrenergic blockers, diuretics, hypoglycemic medications, and systemic corticosteroids 2 weeks prior to visit 1 and throughout the study.
- Subject taking systemic steroids, extreme alcohol use, or drug user.
- Subject has vein access score less than 7
- Subject is a female, who is pregnant, planning to be pregnant during the study period or lactating.
- Subject is a current smoker. Past smoker abstinence for less than 2 years.
- Subject has participated in any clinical trial within 30d prior to enrollment.
- No participation in another Sponsored protocol within 6 months prior to enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Nutrition Research Center
Chicago, Illinois, 60616
About this study
Official title: Effect of Added Fruit Pomace Fiber and Whole Fruit on Postprandial Glycemia in Apple
The primary objective of the study is to compare the effects of a whole apple, apple juice alone, and apple juice with pomace on 2 hr glycemic response as measured by maximal glucose concentration
Read the detailed description
This study is a randomized, 3-arm, within subject cross-over trial allowing for three acute evaluations of 100% Apple Juice (235 g), 100% Apple Juice with enzyme-treated apple pomace fiber (129 g apple juice with 106 g apple pomace), and raw apple (230 g with skin edible portion - not including core or stem) on glucose and insulin responses in fifty-two healthy men and women aged 20-45 years.
A planned sample size of 70 will be enrolled into the study. This study will require one initial screening visit and 3 study visits. This study will take approximately 3-4 weeks per subject to complete.
The initial screening visit will take ~2 hours and provide subject with the informed consent document and determine subject eligibility through anthropometric measurements, body composition measurement, vital signs, fasting blood glucose test (finger prick), a vein access scale evaluation, online 24-hr diet recall, and completion of a survey relate to general eating, health, and exercise habits. For women, a pregnancy test will be conducted.
If willing and eligible to participate, subjects will be invited to participate in the study for 3 study day visits. Eligible subjects will be instructed to follow a relatively low polyphenolic diet for at least 1-week prior the beginning of the study and continue for the duration of the study.
Each Study Day visit will last about ~3 hours. The day before each of the 3 Study Day visits, subjects will be asked to consume the same dinner meal and record on a food record. At each Study Day visit, subjects will arrive at the clinic after fasting for 10 to 12 hours and in a well-hydrated and well-rested state.
Each study visit will require blood draws throughout the visit. After evaluation of subject's health status (via anthropometric, vital sign and blood glucose measurements and in-person interview), a Licensed Health Care Professional will place a catheter in subject's arm for the purpose of multiple blood sample collections and take the initial blood draw in the fasting state. Subjects will be randomized to receive one of study products based on randomized treatment sequences for 3 study visits immediately after fasting blood draw.
Participants will come to the research site on 3 separate occasions separated by a washout period. On each occasion 2 fasting blood samples will be obtained at 5 min intervals (-5, 0 minute (min)). Subjects will then consume one of the 3 treatments. Further blood samples will be taken at 15, 25, 30, 35, 40, 45, 60, 75, 90, 105 and 120 min. Self-reported visual analog scales (VAS) will be used to measure subject hunger, fullness, desire to eat, and prospective food intake at 0, 15, 30, 60, 90, and 120 min. After completion of all study procedures and data/sample collection for the day, the catheter will be removed and subjects will be evaluated for safety and/or discomfort/symptoms before leaving the study site. They will be given a take-home snack and given written instructions in preparation for the next visit. Study day visits will be scheduled at least 3 days apart but no more than 7 days.
- Conditions
- Healthy
- Being tested
- Apple Juice1, Apple Juice2, Raw Apple
- Keywords
- Apple pomace fiber, Glycemic response, Apple
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apple Juice1Dietary supplement
Also called Apple Juice
Apple Juice1
Apple Juice2Dietary supplement
Also called Apple Juice with Pomace Fiber
100% Apple Juice with enzyme-treated apple pomace fiber
Raw AppleDietary supplement
Raw Apple
| Study group | Role | What they receive |
|---|---|---|
| Apple Juice1 | Active comparator | 100% Apple Juice Receives: Dietary Supplement: Apple Juice1 |
| Apple Juice2 | Experimental | 100% Apple Juice with enzyme-treated apple pomace fiber Receives: Dietary Supplement: Apple Juice2 |
| Raw Apple | Placebo comparator | Raw Apple Receives: Dietary Supplement: Raw Apple |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Glucose maximal concentration (Cmax) over 2 hours
Plasma Glucose maximal concentration (Cmax) over 2 hours
Measured: Postprandial 2 hours
Secondary outcomes (1)
Changes in Plasma Glucose concentration as measured by incremental area under the curve (iAUC) over 2 hours
Changes in plasma glucose concentration as measured by iAUC over a 2-hour Postprandial Test day after administration of active treatment compared to control treatment
Measured: Postprandial 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start28 Feb 2019
- Primary completion12 Jun 2020
- Study completion12 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Clinical Nutrition Research Center, Illinois Institute of TechnologyThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Britt Burton-Freeman, Ph.D, Study chair, Illinois Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03846986
- Sponsor's protocol ID
- IRB2018-115
- Acronym
- PAP
- Status last verified
- Jul 2020
- First submitted
- 18 Feb 2019
- Last updated
- 14 Jul 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 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Added Fruit Pomace Fiber and Whole Fruit on Postprandial Glycemia in Apple
- ClinicalTrials.gov ID
- NCT03846986
- Acronym / sponsor ID
- PAP / IRB2018-115
- Conditions
- Healthy
- Keywords
- Apple pomace fiber, Glycemic response, Apple
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Clinical Nutrition Research Center, Illinois Institute of TechnologyIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2019 (actual)
- Primary completion
- 12 Jun 2020 (actual)
- Study completion
- 12 Jun 2020 (actual)
- First posted
- 20 Feb 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.
The primary objective of the study is to compare the effects of a whole apple, apple juice alone, and apple juice with pomace on 2 hr glycemic response as measured by maximal glucose concentration
Detailed description
This study is a randomized, 3-arm, within subject cross-over trial allowing for three acute evaluations of 100% Apple Juice (235 g), 100% Apple Juice with enzyme-treated apple pomace fiber (129 g apple juice with 106 g apple pomace), and raw apple (230 g with skin edible portion - not including core or stem) on glucose and insulin responses in fifty-two healthy men and women aged 20-45 years.
A planned sample size of 70 will be enrolled into the study. This study will require one initial screening visit and 3 study visits. This study will take approximately 3-4 weeks per subject to complete.
The initial screening visit will take ~2 hours and provide subject with the informed consent document and determine subject eligibility through anthropometric measurements, body composition measurement, vital signs, fasting blood glucose test (finger prick), a vein access scale evaluation, online 24-hr diet recall, and completion of a survey relate to general eating, health, and exercise habits. For women, a pregnancy test will be conducted.
If willing and eligible to participate, subjects will be invited to participate in the study for 3 study day visits. Eligible subjects will be instructed to follow a relatively low polyphenolic diet for at least 1-week prior the beginning of the study and continue for the duration of the study.
Each Study Day visit will last about ~3 hours. The day before each of the 3 Study Day visits, subjects will be asked to consume the same dinner meal and record on a food record. At each Study Day visit, subjects will arrive at the clinic after fasting for 10 to 12 hours and in a well-hydrated and well-rested state.
Each study visit will require blood draws throughout the visit. After evaluation of subject's health status (via anthropometric, vital sign and blood glucose measurements and in-person interview), a Licensed Health Care Professional will place a catheter in subject's arm for the purpose of multiple blood sample collections and take the initial blood draw in the fasting state. Subjects will be randomized to receive one of study products based on randomized treatment sequences for 3 study visits immediately after fasting blood draw.
Participants will come to the research site on 3 separate occasions separated by a washout period. On each occasion 2 fasting blood samples will be obtained at 5 min intervals (-5, 0 minute (min)). Subjects will then consume one of the 3 treatments. Further blood samples will be taken at 15, 25, 30, 35, 40, 45, 60, 75, 90, 105 and 120 min. Self-reported visual analog scales (VAS) will be used to measure subject hunger, fullness, desire to eat, and prospective food intake at 0, 15, 30, 60, 90, and 120 min. After completion of all study procedures and data/sample collection for the day, the catheter will be removed and subjects will be evaluated for safety and/or discomfort/symptoms before leaving the study site. They will be given a take-home snack and given written instructions in preparation for the next visit. Study day visits will be scheduled at least 3 days apart but no more than 7 days.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Apple Juice1 | Active comparator | Dietary Supplement: Apple Juice1100% Apple Juice |
| Apple Juice2 | Experimental | Dietary Supplement: Apple Juice2100% Apple Juice with enzyme-treated apple pomace fiber |
| Raw Apple | Placebo comparator | Dietary Supplement: Raw AppleRaw Apple |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- • Subject is a male or female, 20-45 years of age, inclusive.
Key exclusion criteria (16 listed)
- •Subject has fasting finger prick glucose >100 mg/dL.
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 |
|---|---|---|
| Apple Juice1Also: Apple JuiceApple Juice1 | Dietary supplement | Apple Juice1 |
| Apple Juice2Also: Apple Juice with Pomace Fiber100% Apple Juice with enzyme-treated apple pomace fiber | Dietary supplement | Apple Juice2 |
| Raw AppleRaw Apple | Dietary supplement | Raw Apple |
Primary outcome
Plasma Glucose maximal concentration (Cmax) over 2 hours
Time frame: Postprandial 2 hours
Plasma Glucose maximal concentration (Cmax) over 2 hours
1 secondary outcome
Changes in Plasma Glucose concentration as measured by incremental area under the curve (iAUC) over 2 hours
Time frame: Postprandial 2 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 14 Jul 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.
Britt Burton-Freeman, Ph.D study chair
Illinois Institute of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apple Juice1, Apple Juice2 and Raw Apple in people with Healthy, run by Clinical Nutrition Research Center, Illinois Institute of Technology 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 9 inclusion and 16 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 14 Jul 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. 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?
Plasma Glucose maximal concentration (Cmax) over 2 hours (time frame: Postprandial 2 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 14 Jul 2020.