Pharmacokinetic Effect of AstraGin on Whey Protein Absorption and Muscle Function in Healthy Subjects
1 other identifier
interventional
30
1 country
1
Brief Summary
This study gave healthy people supplements with ginseng and astragalus saponin extracts (AstraGin), combined with whey protein, to explore whether it can promote amino acid absorption and thereby enhance protein nutritional status and muscle function. This trial is a randomized, double-blind, crossover trial, and the research subjects are adult healthy subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 26, 2023
CompletedFirst Posted
Study publicly available on registry
October 31, 2023
CompletedStudy Start
First participant enrolled
March 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2024
CompletedDecember 18, 2025
December 1, 2025
7 months
October 26, 2023
December 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The AUC of BCAA in human plasma
Pharmacokinetic ( 0, 15, 30, 45, 60, 90, 120, 150, and 180 minutes)
3 hr
Secondary Outcomes (3)
Plasma TAC Test
4weeks、12weeks
Grip Strength
4weeks、12weeks
Muscle Mass-DXA
4weeks、12weeks
Study Arms (2)
AstraGin
EXPERIMENTALThe 1st round: Before each study day, all subjects took a 50 mg AstraGin capsule at 9 p.m. and began fasting for 12 hours, except for a small amount of water the night before the experiment. On each study day, all subjects collected their first blood sample at 9 a.m. from the median cubital vein using the indwelling catheter method. After the first blood collection, all subjects took 50 mg AstraGin and 35 g of whey protein with 250 mL water. Additional blood samples were collected at 0, 15, 30, 45, 60, 90, 120, 150, and 180 min to analyze the plasma concentration of amino acids. The washout period is seven days, during which the subjects maintain a stable lifestyle and dietary habits. The 2nd round: All subjects take a 50 mg AstraGin capsule and conduct the procedure (same as the 1st round)
Placebo
PLACEBO COMPARATORThe 1st round: Before each study day, all subjects took a 50 mg placebo (maltodextrin) capsule at 9 p.m. and began fasting for 12 hours, except for a small amount of water the night before the experiment. On each study day, all subjects collected their first blood sample at 9 a.m. from the median cubital vein using the indwelling catheter method. After the first blood collection, all subjects took 50 mg placebo and 35 g of whey protein with 250 mL water. Additional blood samples were collected at 0, 15, 30, 45, 60, 90, 120, 150, and 180 min to analyze the plasma concentration of amino acids. The washout period is seven days, during which the subjects maintain a stable lifestyle and dietary habits. The 2nd round: All subjects take a 50 mg Placebo capsule and conduct the procedure (same as the 1st round)
Interventions
In this study, we are investigating the effects of AstraGin on healthy adults. The testing sample is orally administrated to subjects with 35g whey protein + AstraGin. After intervention, a 180-min kinetics study of plasma amino acids was conducted.
In this study, we are investigating the effects of AstraGin on healthy adults. The testing sample is orally administrated to subjects with 35g whey protein + Placebo. After intervention, a 180-min kinetics study of plasma amino acids was conducted.
Eligibility Criteria
You may qualify if:
- Healthy adults and aged 20-65 years.
- Subject has provided written informed consent to participate in the study.
- The subject is willing and able to comply with the study.
You may not qualify if:
- The subject is participating in another clinical trial thirty days prior to enrollment.
- Subject allergy to milk proteins
- Subject has any medical condition or uses any medication, nutritional product, amino acids supplement, or program which might interfere with the conduct of the study or place the subject at risk.
- Subjects lost to follow-up, non-compliance, and concomitant medication.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chung Shan Medical University
Taichung, Taiwan
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 26, 2023
First Posted
October 31, 2023
Study Start
March 30, 2024
Primary Completion
October 30, 2024
Study Completion
October 30, 2024
Last Updated
December 18, 2025
Record last verified: 2025-12