Clinical trial NCT05773794: Scavenging of Reactive Carbonyl Species by Dietary Flavonoids in Humans
Official title: Scavenging of Reactive Carbonyl Species by Dietary Flavonoids From Soymilk, Green Tea, and Blueberry in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Health
Reactive Carbonyl Species
Polyphenols
Keywords: dietary flavonoids
Pharmacokinetics
Reactive Carbonyl Species
Polyphenols
Lead sponsor: North Carolina Agriculture & Technical State University
Sponsor class: OTHER
First posted: 2023-03-17
Enrollment: 48
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is an interventional study to investigate the formation and pharmacokinetics of reactive carbonyl species adducts of dietary polyphenols (soymilk, green tea, and blueberry) in humans after a single dose of dietary flavonoids.

Detailed description: A crossover design was used. Sixteen healthy volunteers (16 for each study, in total 48) were recruited and asked to avoid the consumption of any soymilk, green tea, and blueberry products starting 1 week before intervention and continuing throughout the entire study for a total of 3 weeks.

On week 2, each of the eight participants received 460 ml of soymilk, green tea, and blueberry in a single dose, and afterward, urine and blood samples at different time points over 24 h and fecal samples at different time points over 48 h were collected. Meanwhile, the other eight participants received breakfast (without any soymilk, green tea, and blueberry) at different time points over 48 h were collected.

On the contrary, on week 3, eight participants who received regular milk or water on week 2 received breakfast only, and eight participants who were used as a control on week 2 received soymilk, green tea, and blueberry. And urine and blood samples at different time points over 24 h, and fecal samples at different time points over 48 h for both groups were collected.

Samples will be analyzed by LC-MS/MS. The Pharmacokinetics of conjugates will be investigated.

Eligibility criteria: Inclusion Criteria:

1. Age 25-70 years
2. BMI between 18 and 30
3. Have no known allergy to soy milk
4. Be not taking antibiotics for six months
5. Be not currently taking medication

   1. No taking any prescription drugs
   2. If supplements were taken, flavonoid-enriched supplements (see list below) should be avoided.

      Major brands Notes: All flavonoid-enriched supplements should be avoided. Soy Isoflavones/ tea/blueberry 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
   3. No any drugs or supplements within three weeks of the experiment
6. Be nonsmoking
7. Have no alcoholic intoxication

   1. No alcoholic addiction
   2. \< 3-4 drinks per week (less than 2 glasses (300 mL) per drink)
   3. No alcohol within 3 three weeks of the experiment
8. 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

   1. Currently diagnosed cancer patients will be excluded;
   2. Medication free for \>2 years could be considered;

Primary outcomes:
measure: Change in Urinary Levels of Reactive Carbonyl Species (RCS) of Soymilk, Green Tea, or Blueberry Over 8 Hours After One Single Dose of Soymilk, Green Tea, or Blueberry Consumption.
timeFrame: assessed at 0-2 hours, 2-4 hours, 4-6 hours, and 6-8 hours post-dose
measure: Change in Plasma Levels of Reactive Carbonyl Species (RCS) of Soymilk, Green Tea, or Blueberry Over 4 Hours After One Single Dose of Soymilk, Green Tea, or Blueberry Consumption.
timeFrame: assessed at 0 hour, 0.5 hour, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours post-dose
measure: Change in Urinary Levels of Reactive Carbonyl Species (RCS) Adducts of Soymilk, Green Tea, or Blueberry Polyphenols Over 24 Hours After One Single Dose of Soymilk, Green Tea, or Consumption.
timeFrame: 0-2 hours, 2-4 hours, 4-6 hours,6-8 hours, 8-12 hours, and 12-24 hours post-dose
Secondary outcomes:
measure: Change in Plasma Levels of Reactive Carbonyl Species (RCS) Adducts of Soymilk, Green Tea, or Blueberry Polyphenols Over 24 Hours After One Single Dose of Soymilk, Green Tea, or Consumption.
timeFrame: 0 hour, 0.5 hour, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, and 24 hours pose dose
measure: Change in Levels of Reactive Carbonyl Species (RCS) Adducts of Soymilk, Green Tea, or Blueberry Polyphenols in Feces Over 48 Hours After One Single Dose of Soymilk, Green Tea, or Consumption.
timeFrame: 0 hour, 24 hours, and 48 hours post-dose
Other outcomes:
Locations:
city: Kannapolis
country: United States
facility: North Carolina Agriculture and Technical State University
state: North Carolina
Study officials:
affiliation: NC A&T State University
name: Shengmin Sang, PhD
role: PRINCIPAL_INVESTIGATOR
References: