Human HealthNCT03911050
Scavenging of Reactive Carbonyl Species by Apple Polyphenols in Human
A study testing Apple consumption in people with Human Health and Polyphenols, run by North Carolina Agriculture & Technical State University at 1 site in United States.
Trial summary
This is an interventional study to investigate formation and pharmacokinetics of reactive carbonyl species adducts of apple polyphenols in human after a single dose of apple consumption. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Health, Polyphenols, Pharmacokinetics
- What is being tested?
- Apple consumption
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Nov 2018to 21 Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI between 17 and 30
- Have blood and urine biochemical markers in normal range
- Have no known allergy to apples
- Be not taking antibiotics for six months
- Be not currently taking medication
- Be nonsmoking
Show all 9Show fewer
- Have no alcoholic intoxication
- Have no extensive exposure to industrial wastes
- Be not frequent charred meat consumption
Who cannot join
- Individuals with gout
- Individuals with heart diseases
- Individuals with peripheral vascular diseases
- Individuals with degenerative kidney
- Individuals with degenerative liver
- Cancer patients
Show all 9Show fewer
- Patients with diabetes
- Individuals with GI disorders
- Individuals with endocrine disorders
Trial locations and contacts
1 site in 1 country.
United States1 site
North Carolina Agriculture and Technical State University
Kannapolis, North Carolina, 28081
About this study
Official title: Scavenging of Endogenous Reactive Carbonyl Species by Apple Polyphenols in Healthy Human Subjects
This is an interventional study to investigate formation and pharmacokinetics of reactive carbonyl species adducts of apple polyphenols in human after a single dose of apple consumption.
Read the detailed description
A crossover design was used. Twelve healthy volunteers were recruited and asked to avoid the consumption of any apple products starting 1 week before intervention and continuing throughout the entire study for a total of 3 weeks.
On week 2, each of six participants received 600 g apple blends (seeds removal) in a single dose, and afterwards, urine and blood samples at different timepoints over 24 h, and fecal sample at different timepoints over 48 h were collected. Meanwhile, other six participants received breakfast (without any apple products) only, and urine and blood samples at different timepoints over 24 h, and fecal sample at different timepoints over 48 h were collected.
On the contrary, on week 3, six participants who received apple blends on week 2 received breakfast only, and six participants who were used as control on week 2 received apple blends. And urine and blood samples at different timepoints over 24 h, and fecal sample at different timepoints over 48 h for both groups were collected.
Samples will be analyzed by LC-MS/MS. Pharmacokinetics of conjugates will be investigated.
- Conditions
- Human Health, Polyphenols, Pharmacokinetics
- Being tested
- Apple consumption, Control group
- Keywords
- endogenous reactive carbonyl species, apple consumption, formation of carbonyl species adducts of apple polyphenols, pharmacokinetics of adducts in human, intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apple consumptionDietary supplement
Apple blends (600 g) One single dose
Control groupDietary supplement
Breakfast without any apple-related products
| Study group | Role | What they receive |
|---|---|---|
| Apple consumption | Experimental | Each subject took apple blends 600 g (made from two apples with seed removal) in a single dose, and samples (urine and blood and feces) at different timepoints were collected following administration of apple blends. Receives: Dietary Supplement: Apple consumption |
| Control group | Placebo comparator | Each subject took breakfast without any apple-related products in a single dose, and samples (urine and blood and feces) at different timepoints were collected following breakfast. Receives: Dietary Supplement: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Urinary Excretion Rates of Major Reactive Carbonyl Species (RCS) Adducts of Apple Polyphenols Over 24 Hours After One Single Dose of Apple Consumption
Urinary excretion rates of major reactive carbonyl species (RCS) conjugates were determined using LC-MS analysis. Urine samples were enzymatically hydrolyzed. Chromatographic separation of RCS-polyphenols (PPs) in human urine was performed on a Gemini column (50 mm × 2.0 mm; i.d. 3 μm) using a Dionex HPLC. Targeted conjugates were identified using an LTQ Velos Pro ion trap mass spectrometer equipped with an electrospray ionization (ESI) source operating in negative ion mode. Quantitation for RCS-PPs was carried out by using multiple reaction monitoring (MRM3) transitions (parent → product ion), and data were processed using Xcalibur Quan Browser (Version 4.2.47).
Measured: Urinary excretion rates (ERs) of ACR-PPs and MGO-PPs at different time intervals (0-2, 2-4, 4-6, 6-9, 9-12, and 12-24 h) after apple consumption were measured. The maximum ERs at 6 h post-dose for ACR-PPs and 9 h post-dose for MGO-PPs were presented.
Change in Plasma Levels of Major RCS Adducts of Apple Polyphenols Over 24 Hours After One Single Dose of Apple Consumption
Levels of RCS adducts of apple polyphenols in plasma will be determined by Liquid chromatography-tandem mass spectrometry analysis.
Measured: Major RCS conjugates in plasma at different timepoints (0, 0.5, 1, 1.5, 2, 4, 8, and 24 h) after apple consumption were analyzed.
Change in Levels of RCS Adducts of Apple Polyphenols in Feces Over 48 Hours After One Single Dose of Apple Consumption
Liquid chromatography-tandem mass spectrometry will be utilized to assess RCS adducts of apple polyphenols in fecal samples
Measured: Major RCS adducts of apple polyphenols at different time intervals (0, 0-24, and 24-48 h) after apple consumption were analyzed.
Secondary outcomes (2)
Average Urinary Excretion Rates of Major RCS (e.g. ACR and MGO) Over 24 Hours After One Single Dose of Apple Consumption
Average excretion rates of major RCS in urine were determined by Liquid chromatography-tandem mass spectrometry analysis. Urine samples were derivatized with DNPH solution. Chromatographic separation of RCS-DNPH adducts in samples was conducted on an Accucore C8 column. The thermo Q Exactive Plus Orbitrap mass spectrometer equipped with a heated-electrospray ionization (HESI) source was operated in a highly sensitive targeted-single ion monitoring (tSIM) mode, with positive ion polarity from 0 to 4.6 min and negative ion polarity from 4.6 to 13 min, for quantitative analysis.
Measured: Urinary excretion rates (ERs) of major RCS (e.g. ACR and MGO) at different time intervals (0-2, 2-4, 4-6, 6-9, 9-12, and 12-24 h) post-dose were measured. Average urinary ERs of ACR and MGO within 24 h were presented.
Average Plasma Levels of Major RCS (ACR and MGO) Over 24 Hours After One Single Dose of Apple Consumption
Plasma levels of major RCS were determined by Liquid chromatography-tandem mass spectrometry analysis. Plasma samples were derivatized with DNPH solution. Chromatographic separation of RCS-DNPH adducts in samples was conducted on an Accucore C8 column. The thermo Q Exactive Plus Orbitrap mass spectrometer equipped with a heated-electrospray ionization (HESI) source was operated in a highly sensitive targeted-single ion monitoring (tSIM) mode, with positive ion polarity from 0 to 4.6 min and negative ion polarity from 4.6 to 13 min, for quantitative analysis.
Measured: Plasma levels of major RCS (e.g. ACR and MGO) at different time points (0, 0.5, 1.0, 1.5, 2.0, 4.0, 8.0, and 24 h) post-dose were measured. Average plasma levels of ACR and MGO within 24 h were presented.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start26 Nov 2018
- Primary completion14 Dec 2018
- Study completion21 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Human HealthStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Carolina Agriculture & Technical State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shengmin Sang, North Carolina Agriculture & Technical State University
- Investigators
- Shengmin Sang, PhD, Principal investigator, North Carolina Agriculture & Technical State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03911050
- Sponsor's protocol ID
- 18-0089
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2019
- Last updated
- 2 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scavenging of Endogenous Reactive Carbonyl Species by Apple Polyphenols in Healthy Human Subjects
- ClinicalTrials.gov ID
- NCT03911050
- Acronym / sponsor ID
- 18-0089
- Conditions
- Human Health, Polyphenols, Pharmacokinetics
- Keywords
- endogenous reactive carbonyl species, apple consumption, formation of carbonyl species adducts of apple polyphenols, pharmacokinetics of adducts in human, intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- North Carolina Agriculture & Technical State UniversityUniversity, hospital or other
- Study start
- 26 Nov 2018 (actual)
- Primary completion
- 14 Dec 2018 (actual)
- Study completion
- 21 Dec 2018 (actual)
- First posted
- 10 Apr 2019 (actual)
- Results
- Posted 2 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an interventional study to investigate formation and pharmacokinetics of reactive carbonyl species adducts of apple polyphenols in human after a single dose of apple consumption.
Detailed description
A crossover design was used. Twelve healthy volunteers were recruited and asked to avoid the consumption of any apple products starting 1 week before intervention and continuing throughout the entire study for a total of 3 weeks.
On week 2, each of six participants received 600 g apple blends (seeds removal) in a single dose, and afterwards, urine and blood samples at different timepoints over 24 h, and fecal sample at different timepoints over 48 h were collected. Meanwhile, other six participants received breakfast (without any apple products) only, and urine and blood samples at different timepoints over 24 h, and fecal sample at different timepoints over 48 h were collected.
On the contrary, on week 3, six participants who received apple blends on week 2 received breakfast only, and six participants who were used as control on week 2 received apple blends. And urine and blood samples at different timepoints over 24 h, and fecal sample at different timepoints over 48 h for both groups were collected.
Samples will be analyzed by LC-MS/MS. Pharmacokinetics of conjugates will be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apple consumption | Experimental | Dietary Supplement: Apple consumptionEach subject took apple blends 600 g (made from two apples with seed removal) in a single dose, and samples (urine and blood and feces) at different timepoints were collected following administration of apple blends. |
| Control group | Placebo comparator | Dietary Supplement: Control groupEach subject took breakfast without any apple-related products in a single dose, and samples (urine and blood and feces) at different timepoints were collected following breakfast. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- BMI between 17 and 30
- Have blood and urine biochemical markers in normal range
- Have no known allergy to apples
- Be not taking antibiotics for six months
- Be not currently taking medication
Key exclusion criteria (9 listed)
- Individuals with gout
- Individuals with heart diseases
- Individuals with peripheral vascular diseases
- Individuals with degenerative kidney
- Individuals with degenerative liver
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 consumptionApple blends (600 g) One single dose | Dietary supplement | Apple consumption |
| Control groupBreakfast without any apple-related products | Dietary supplement | Control group |
Primary outcome
Maximum Urinary Excretion Rates of Major Reactive Carbonyl Species (RCS) Adducts of Apple Polyphenols Over 24 Hours After One Single Dose of Apple Consumption
Time frame: Urinary excretion rates (ERs) of ACR-PPs and MGO-PPs at different time intervals (0-2, 2-4, 4-6, 6-9, 9-12, and 12-24 h) after apple consumption were measured. The maximum ERs at 6 h post-dose for ACR-PPs and 9 h post-dose for MGO-PPs were presented.
Urinary excretion rates of major reactive carbonyl species (RCS) conjugates were determined using LC-MS analysis. Urine samples were enzymatically hydrolyzed. Chromatographic separation of RCS-polyphenols (PPs) in human urine was performed on a Gemini column (50 mm × 2.0 mm; i.d. 3 μm) using a Dionex HPLC. Targeted conjugates were identified using an LTQ Velos Pro ion trap mass spectrometer equipped with an electrospray ionization (ESI) source operating in negative ion mode. Quantitation for RCS-PPs was carried out by using multiple reaction monitoring (MRM3) transitions (parent → product ion), and data were processed using Xcalibur Quan Browser (Version 4.2.47).
Change in Plasma Levels of Major RCS Adducts of Apple Polyphenols Over 24 Hours After One Single Dose of Apple Consumption
Time frame: Major RCS conjugates in plasma at different timepoints (0, 0.5, 1, 1.5, 2, 4, 8, and 24 h) after apple consumption were analyzed.
Levels of RCS adducts of apple polyphenols in plasma will be determined by Liquid chromatography-tandem mass spectrometry analysis.
Change in Levels of RCS Adducts of Apple Polyphenols in Feces Over 48 Hours After One Single Dose of Apple Consumption
Time frame: Major RCS adducts of apple polyphenols at different time intervals (0, 0-24, and 24-48 h) after apple consumption were analyzed.
Liquid chromatography-tandem mass spectrometry will be utilized to assess RCS adducts of apple polyphenols in fecal samples
2 secondary outcomes
Average Urinary Excretion Rates of Major RCS (e.g. ACR and MGO) Over 24 Hours After One Single Dose of Apple Consumption
Time frame: Urinary excretion rates (ERs) of major RCS (e.g. ACR and MGO) at different time intervals (0-2, 2-4, 4-6, 6-9, 9-12, and 12-24 h) post-dose were measured. Average urinary ERs of ACR and MGO within 24 h were presented.
Average Plasma Levels of Major RCS (ACR and MGO) Over 24 Hours After One Single Dose of Apple Consumption
Time frame: Plasma levels of major RCS (e.g. ACR and MGO) at different time points (0, 0.5, 1.0, 1.5, 2.0, 4.0, 8.0, and 24 h) post-dose were measured. Average plasma levels of ACR and MGO within 24 h were presented.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Shengmin Sang, PhD principal investigator
North Carolina Agriculture & Technical State University
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 consumption in people with Human Health and Polyphenols, run by North Carolina Agriculture & Technical State University 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 9 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 2 Jul 2026. 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?
Yes. Results are posted in the registry (first posted 2 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Urinary Excretion Rates of Major Reactive Carbonyl Species (RCS) Adducts of Apple Polyphenols Over 24 Hours After One Single Dose of Apple Consumption (time frame: Urinary excretion rates (ERs) of ACR-PPs and MGO-PPs at different time intervals (0-2, 2-4, 4-6, 6-9, 9-12, and 12-24 h) after apple consumption were measured. The maximum ERs at 6 h post-dose for ACR-PPs and 9 h post-dose for MGO-PPs were presented.). The study lists 3 primary outcomes in all. 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 2 Jul 2026.