NCT06110260

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 31, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

March 30, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2024

Completed
Last Updated

December 18, 2025

Status Verified

December 1, 2025

Enrollment Period

7 months

First QC Date

October 26, 2023

Last Update Submit

December 10, 2025

Conditions

Keywords

BCAAGinseng and Astragalus Saponin ExtractWhey ProteinPharmacokinetics

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

EXPERIMENTAL

The 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)

Dietary Supplement: AstraGin (Ginseng and Astragalus Saponin Extract)

Placebo

PLACEBO COMPARATOR

The 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)

Dietary Supplement: Placebo

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.

AstraGin
PlaceboDIETARY_SUPPLEMENT

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.

Placebo

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Interventions

Asian ginseng

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

Locations