Pharmacokinetic Effect of AstraGin on Whey Protein Absorption and Muscle Function in Healthy Subjects

NCT ID: NCT06110260

Last Updated: 2023-10-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-30
• Study Completion Date: 2024-09-30

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.

Detailed Description

A randomized-double blind, crossover human trial. 30 healthy adults, subdivided into two groups, are randomized into treatments and placebo groups to ensure equally balanced randomization and comparability, considering factors including age, sex, and diet.

(2) The 1st round: Before each study day, all subjects took a 50 mg AstraGin/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 AstraGin/placebo and 35 g of whey protein with 250 mL water.

(3) 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.

(5) 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/AstraGin capsule and conduct the procedure (same as the 1st round)

Conditions

Pharmacokinetic Effect of AstraGin on Whey Protein Absorption and Muscle Function in Healthy Subjects

Keywords

BCAA; Ginseng and Astragalus Saponin Extract; Whey Protein; Pharmacokinetics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

AstraGin

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)

Group Type: EXPERIMENTAL

AstraGin (Ginseng and Astragalus Saponin Extract)

Intervention Type: DIETARY_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 + AstraGin. After intervention, a 180-min kinetics study of plasma amino acids was conducted.

Placebo

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)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_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.

Interventions

AstraGin (Ginseng and Astragalus Saponin Extract)

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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chung Shan Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chung Shan Medical University

Taichung, , Taiwan

Countries

Taiwan

Central Contacts

You-Cheng Mr Shen, Ph.D.

Role: CONTACT

Phone: 886-4-24730022

Email: youcheng@csmu.edu.tw

Other Identifiers

CS1-23151

Identifier Type: -

Identifier Source: org_study_id