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NCT Number: NCT07767149

Effects of Flavonoid 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 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).

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Key information

Age range

25 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

North Carolina Agriculture and Technical State University/ NRI Building

Kannapolis, North Carolina, 28081, United States

Location status: Recruiting

Location contact

Samantha Caroll

CONTACT

[email protected]

7047013024

About this study

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. 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). We 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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. Age 25-70 years 2. BMI between 18 and 30 3. Have no known allergy to test food 4. have no known allergies to green tea, apples, blueberries, soy milk, and pineapples 5. Be not engaging in high-intensity exercise 6. Having blood and urine clinical tests in the normal range. 7. Be not taking antibiotics for six months 8. Be not currently taking medication
  • No taking any prescription drugs
  • If supplements were taken, flavonoid-enriched supplements (see list below) should be avoided.

Major brands Notes Soy Isoflavones All flavonoid-enriched supplements should be avoided. Lipo-Flavonoid Citrus Bioflavonoids Complex Super Flavonoids Super Antioxidants Quercetin Supplement Essential-C and flavonoids Milk Thistle Other flavonoids supplements, including but not limited: Luteolin, Rutin, etc

  • No any drugs or supplements within three weeks of the experiment 9. Be nonsmoking 10. Have no alcoholic intoxication

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  • No alcoholic addiction
  • < 3-4 drinks per week (less than 2 glasses (300 mL) per drink)
  • No alcohol within 3 three weeks of the experiment 11. Have no extended exposure to industrial wastes

Exclusion criteria

  • 1. Disease: gout, heart disease, peripheral vascular disease, degenerative kidney, degenerative liver, diabetes, GI disorders, or endocrine disorders 2. Cancer patients
  • Currently diagnosed cancer patients will be excluded.
  • Medication free for >2 years could be considered.

Treatment and study plan

High-Flavonoid Diet

Dietary 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 Diet

Dietary 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.

Primary outcomes

  1. 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 LC-MS.

Secondary outcomes

  1. Association Between Carbonyl Stress Biomarkers and Flavonoid RCS Conjugates

    Time frame: After the 3-week dietary intervention

    Association between changes in urinary reactive carbonyl species and the formation of flavonoid RCS-conjugated metabolites measured by LC-MS.

Study contacts

Contact information is provided by the study sponsor or research team.

Shengmin Sang

CONTACT

[email protected]

704-250-5710

Sponsors and collaborators

Lead sponsor

North Carolina Agriculture & Technical State University

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

Effects of Flavonoid-rich Foods on Carbonyl Stress

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 17, 2026
Registry last updated
Aug 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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