Effects of Flavonoid Foods on Carbonyl Stress
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-70
SponsorNorth Carolina Agriculture & Technical State University
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Crossover
Treatments tested in this trial
High-Flavonoid Diet
Dietary supplementParticipants 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 supplementParticipants 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.
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: High-Flavonoid Diet, Then Low-Flavonoid DietExperimental treatment 2 interventions
Group B: Low-Flavonoid Diet Followed by High-Flavonoid DietExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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).
Time frame
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).
Time frame
After the 3-week dietary interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
North Carolina Agriculture & Technical State University
Lead sponsor
National Institutes of Health (NIH)
Collaborator
Source ClinicalTrials.gov