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

Chung Shan Medical University

Status: Completed

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

Treatments: Dietary Supplement: Placebo; Dietary Supplement: AstraGin (Ginseng and Astragalus Saponin Extract)

Study type: Interventional

Funder types: Other

Identifiers

NCT06110260

CS1-23151

Details and patient eligibility

About

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.

Full 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)

Enrollment: 30 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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 diabetes, obesity, hypertension, cardiovascular disease, liver or kidney disease, current infections, and smoking were exclusion criteria.
• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

AstraGin

Experimental group

Description:

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)

Treatment:

Dietary Supplement: AstraGin (Ginseng and Astragalus Saponin Extract)

Placebo

Placebo Comparator group

Description:

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)

Treatment:

Dietary Supplement: Placebo