Human HealthNCT07767149
Effects of Flavonoid Foods on Carbonyl Stress
A study testing High-Flavonoid Diet and Low-Flavonoid Diet in people with Human Health and Flavonoids, run by North Carolina Agriculture & Technical State University at 1 site in United States.
Trial summary
This randomized crossover study will compare low- and high-flavonoid diets in healthy adults to identify flavonoid-derived biomarkers in urine and plasma. Using targeted liquid chromatography-mass spectrometry (LC-MS) metabolomics, researchers will measure known and novel flavonoid metabolites and evaluate whether a… Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Health, Flavonoids, Carbonyl Stress
- What is being tested?
- High-Flavonoid Diet and Low-Flavonoid Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 25-70 years
- BMI between 18 and 30
- Have no known allergy to test food
- Have no known allergies to green tea, apples, blueberries, soy milk, or pineapples
- Be not engaging in high-intensity exercise
- Having blood and urine clinical tests in the normal range.
Show all 17Show fewer
- Be not taking antibiotics for six months
- Be not currently taking medication
- No taking any prescription drugs
- All flavonoid-enriched supplements should be avoided. The flavonoid-enriched supplements list includes soy isoflavones, Lipo-Flavonoid, Citrus Bioflavonoids Complex, Super Flavonoids, Super Antioxidants, Quercetin Supplement, Essential-C, flavonoids, and milk thistle. Also other flavonoid supplements, including but not limited to luteolin, Rutin, etc.
- No drugs or supplements within three weeks of the experiment
- Be nonsmoking
- Have no alcoholic intoxication
- No alcoholic addiction
- < 3-4 drinks per week (less than 2 glasses (300 mL) per drink)
- No alcohol within three weeks of the experiment
- Have no extended exposure to industrial wastes
Who cannot join
- Disease: gout, heart disease, peripheral vascular disease, degenerative kidney, degenerative liver, diabetes, GI disorders, or endocrine disorders
- Cancer patients
- Currently diagnosed cancer patients will be excluded.
- Medication-free for >2 years could be considered.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
North Carolina Agriculture and Technical State University/ NRI Building
Kannapolis, North Carolina, 28081
Samantha Caroll, 7047013024, samantha_carroll@unc.edu
About this study
Official title: Effects of Flavonoid-rich Foods on Carbonyl Stress
This randomized crossover study will compare low- and high-flavonoid diets in healthy adults to identify flavonoid-derived biomarkers in urine and plasma. Using targeted liquid chromatography-mass spectrometry (LC-MS) metabolomics, researchers will measure known and novel flavonoid metabolites and evaluate whether a higher flavonoid intake reduces carbonyl stress markers, including reactive carbonyl species (RCS) and advanced glycation end products (AGEs).
Read the detailed description
Biomarkers of flavonoids and flavonoid-rich foods are needed to monitor diets. Monitoring diets and associating dietary patterns with health risks and outcomes is an essential step in the research process. The goal of this study is to determine the time- and dose-dependent formation of novel flavonoid metabolites in urine and plasma samples by conducting a randomized crossover trial of two dietary interventions with low (~140 mg flavonoids/day) and high (~420 mg flavonoids/day) flavonoid diets among healthy individuals.
Foods with high or low flavonoid content will be incorporated into participants' usual diets. Liquid chromatography-mass spectrometry (LCMS)-based targeted metabolomics will be used to assess flavonoid metabolites, including novel RCS-conjugated and oxidized flavonoid metabolites, and to determine whether consuming a flavonoid-rich diet will lead to a decrease in carbonyl stress as measured by RCS and related advanced glycation end products (AGEs). Investigators will determine the changes in the major RCS and related AGEs after each intervention period using LCMS and examine the relationship between changes in RCS and AGEs and the formation of flavonoid RCS conjugates
- Conditions
- Human Health, Flavonoids, Carbonyl Stress
- Being tested
- High-Flavonoid Diet, Low-Flavonoid Diet
- Keywords
- flavonoids, Carbonyl stress, Advanced glycation end products (AGEs), Metabolomics, Reactive carbonyl species (RCS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Flavonoid DietDietary supplement
Participants will consume the high-flavonoid diet daily for 3 weeks. The diet includes 1 Red Delicious apple (approximately 160 g), freeze-dried whole blueberry powder (25 g), soy milk (240 mL), and decaffeinated Lipton green tea ( 2 g tea leaves), providing approximately 420 mg flavonoids per day.
Low-Flavonoid DietDietary supplement
Participants will consume the low-flavonoid diet daily for 3 weeks. The diet includes 1/3 of Red Delicious, 107 g of pineapple; 8.3 g of blueberry powder plus 16.7 g of blueberry placebo powder; 80 mL of soy milk plus 160 mL of 2% low-fat milk; and 0.67 g tea leaves, providing approximately 140 mg flavonoids per day.
| Study group | Role | What they receive |
|---|---|---|
| High-Flavonoid Diet, Then Low-Flavonoid Diet | Experimental | All participants will first complete a 2-week low-flavonoid wash-in period. Participants in this sequence will then consume the high-flavonoid diet for 3 weeks, complete a 3-week low-flavonoid washout period, and then consume the low-flavonoid diet for 3 weeks. Receives: Dietary Supplement: High-Flavonoid Diet; Dietary Supplement: Low-Flavonoid Diet |
| Low-Flavonoid Diet Followed by High-Flavonoid Diet | Experimental | All participants will first complete a 2-week low-flavonoid wash-in period. Participants in this sequence will then consume the low-flavonoid diet for 3 weeks, complete a 3-week low-flavonoid washout period, and then consume the high-flavonoid diet for 3 weeks. Receives: Dietary Supplement: High-Flavonoid Diet; Dietary Supplement: Low-Flavonoid Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma and Urine Flavonoid Metabolites
Change in plasma and urine concentrations of flavonoid metabolites, including reactive carbonyl species (RCS)-conjugated flavonoid metabolites, measured by liquid chromatography-mass spectrometry (LC-MS).
Measured: After the 3-week dietary intervention period.
Secondary outcomes (1)
Association Between Carbonyl Stress Biomarkers and Flavonoid RCS Conjugates
Association between changes in urinary reactive carbonyl species and the formation of flavonoid RCS-conjugated metabolites measured by liquid chromatography-mass spectrometry (LC-MS).
Measured: After the 3-week dietary intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start2 Sep 2026 (estimated)
- Primary completion15 Oct 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- North Carolina Agriculture & Technical State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Shengmin Sang, North Carolina Agriculture & Technical State University
- Investigators
- Shengmin Sang, Principal investigator, North Carolina A&T State University Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07767149
- Sponsor's protocol ID
- 25-0075
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- 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 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Flavonoid-rich Foods on Carbonyl Stress
- ClinicalTrials.gov ID
- NCT07767149
- Acronym / sponsor ID
- 25-0075
- Conditions
- Human Health, Flavonoids, Carbonyl Stress
- Keywords
- flavonoids, Carbonyl stress, Advanced glycation end products (AGEs), Metabolomics, Reactive carbonyl species (RCS)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- North Carolina Agriculture & Technical State UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 2 Sep 2026 (estimated)
- Primary completion
- 15 Oct 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Aug 2026 (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.
This randomized crossover study will compare low- and high-flavonoid diets in healthy adults to identify flavonoid-derived biomarkers in urine and plasma. Using targeted liquid chromatography-mass spectrometry (LC-MS) metabolomics, researchers will measure known and novel flavonoid metabolites and evaluate whether a higher flavonoid intake reduces carbonyl stress markers, including reactive carbonyl species (RCS) and advanced glycation end products (AGEs).
Detailed description
Biomarkers of flavonoids and flavonoid-rich foods are needed to monitor diets. Monitoring diets and associating dietary patterns with health risks and outcomes is an essential step in the research process. The goal of this study is to determine the time- and dose-dependent formation of novel flavonoid metabolites in urine and plasma samples by conducting a randomized crossover trial of two dietary interventions with low (~140 mg flavonoids/day) and high (~420 mg flavonoids/day) flavonoid diets among healthy individuals.
Foods with high or low flavonoid content will be incorporated into participants' usual diets. Liquid chromatography-mass spectrometry (LCMS)-based targeted metabolomics will be used to assess flavonoid metabolites, including novel RCS-conjugated and oxidized flavonoid metabolites, and to determine whether consuming a flavonoid-rich diet will lead to a decrease in carbonyl stress as measured by RCS and related advanced glycation end products (AGEs). Investigators will determine the changes in the major RCS and related AGEs after each intervention period using LCMS and examine the relationship between changes in RCS and AGEs and the formation of flavonoid RCS conjugates
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-Flavonoid Diet, Then Low-Flavonoid Diet | Experimental | Dietary Supplement: High-Flavonoid Diet, Dietary Supplement: Low-Flavonoid DietAll participants will first complete a 2-week low-flavonoid wash-in period. Participants in this sequence will then consume the high-flavonoid diet for 3 weeks, complete a 3-week low-flavonoid washout period, and then consume the low-flavonoid diet for 3 weeks. |
| Low-Flavonoid Diet Followed by High-Flavonoid Diet | Experimental | Dietary Supplement: High-Flavonoid Diet, Dietary Supplement: Low-Flavonoid DietAll participants will first complete a 2-week low-flavonoid wash-in period. Participants in this sequence will then consume the low-flavonoid diet for 3 weeks, complete a 3-week low-flavonoid washout period, and then consume the high-flavonoid diet for 3 weeks. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age 25-70 years
- BMI between 18 and 30
- Have no known allergy to test food
- Have no known allergies to green tea, apples, blueberries, soy milk, or pineapples
- Be not engaging in high-intensity exercise
Key exclusion criteria (4 listed)
- Disease: gout, heart disease, peripheral vascular disease, degenerative kidney, degenerative liver, diabetes, GI disorders, or endocrine disorders
- Cancer patients
- Currently diagnosed cancer patients will be excluded.
- Medication-free for >2 years could be considered.
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 |
|---|---|---|
| High-Flavonoid DietParticipants will consume the high-flavonoid diet daily for 3 weeks. The diet includes 1 Red Delicious apple (approximately 160 g), freeze-dried whole blueberry powder (25 g), soy milk (240 mL), and decaffeinated Lipton green tea ( 2 g tea leaves), providing approximately 420 mg flavonoids per day. | Dietary supplement | High-Flavonoid Diet, Then Low-Flavonoid Diet, Low-Flavonoid Diet Followed by High-Flavonoid Diet |
| Low-Flavonoid DietParticipants will consume the low-flavonoid diet daily for 3 weeks. The diet includes 1/3 of Red Delicious, 107 g of pineapple; 8.3 g of blueberry powder plus 16.7 g of blueberry placebo powder; 80 mL of soy milk plus 160 mL of 2% low-fat milk; and 0.67 g tea leaves, providing approximately 140 mg flavonoids per day. | Dietary supplement | High-Flavonoid Diet, Then Low-Flavonoid Diet, Low-Flavonoid Diet Followed by High-Flavonoid Diet |
Primary outcome
Plasma and Urine Flavonoid Metabolites
Time frame: After the 3-week dietary intervention period.
Change in plasma and urine concentrations of flavonoid metabolites, including reactive carbonyl species (RCS)-conjugated flavonoid metabolites, measured by liquid chromatography-mass spectrometry (LC-MS).
1 secondary outcome
Association Between Carbonyl Stress Biomarkers and Flavonoid RCS Conjugates
Time frame: After the 3-week dietary intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
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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.
Shengmin Sang principal investigator
North Carolina A&T State University Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Flavonoid Diet and Low-Flavonoid Diet in people with Human Health and Flavonoids, 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 17 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 24 Aug 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shengmin Sang (704-250-5710, ssang@ncat.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma and Urine Flavonoid Metabolites (time frame: After the 3-week dietary intervention period.). 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 24 Aug 2026.