Effects of Cyclodextrin on Circulating Branched-Chain a-Keto Acid Levels and Inflammatory Regulation in Healthy Individuals

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2600118017

Enrollment

Unknown

Registered

2026-01-31

Start date

2026-01-31

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

healthy subject

Interventions

15 g dissolved in 50 mL water

BCAA supplementation group:BCAA supplementation group: Participants received an oral BCAA supplement (BY-HEALTH Leduo? Post-exercise Branched-Chain Amino Acid Recovery Powder: 14 g dissolved in 50 mL

BCAA supplementation + HP-ß-CD group:After a 1-week washout period, with fasting and fluid restriction identical to the previous session, BCAA supplementation + HP-ß-CD group: Participants received o

Purified water control group:Purified water control group: Participants received 50 mL of purified water orally. Blood samples were collected at 0.5, 1, 2, and 3 hours after administration to measure

HP-ß-CD group:After a one-week washout period, with fasting and fluid restriction identical to the previous phase, HP-ß-CD group: Participants received oral HP-ß-cyclodextrin (HP-ß-CD

manufactured by Shandong Zhiyuan Biotech). Blood samples were collected at 0.5, 1, 2, and 3 hours after administration to determine plasma concentrations of free BCAAs, BCKAs, and inflammatory mark

Eligibility

Sex/Gender

All

Age

18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18–45 years; 2. Body Mass Index (BMI) between 18.5–24 kg/m²; 3. No history of cardiovascular, metabolic, hepatic or renal disorders, or acute/chronic inflammatory conditions; 4. No recent (within 1 month) use of medications or supplements affecting metabolism (e.g. hormonal agents, high-dose vitamins).

Exclusion criteria

Exclusion criteria: 1. Smokers, heavy drinkers, or individuals with specific dietary requirements; 2. Pregnant or breastfeeding women; 3. Patients unable to provide informed consent; 4. Those experiencing language barriers or difficulties in communication and comprehension.

Design outcomes

Primary

Measure	Time frame
Branched-chain a-keto acid concentration;	—

Secondary

Measure	Time frame
Branched-chain amino acid concentration;IL-1ß;Tumour Necrosis Factor Alpha;	—

Countries

China

Contacts

Public ContactLi Zhou

Huaxi hospital of Sichuan university

714549399@qq.com+86 189 8060 6160

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026