Clinical trial NCT06110260: Pharmacokinetic Effect of AstraGin on Whey Protein Absorption and Muscle Function in Healthy Subjects
Official title: Pharmacokinetic Effect of AstraGin on Whey Protein Absorption and Muscle Function in Healthy Subjects: A Randomized, Double-blind, Crossover Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
First posted: 2023-10-31
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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)

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 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.

Primary outcomes:
measure: The AUC of BCAA in human plasma
timeFrame: 3 hr
Secondary outcomes:
measure: Plasma TAC Test
timeFrame: 4weeks、12weeks
measure: Grip Strength
timeFrame: 4weeks、12weeks
measure: Muscle Mass-DXA
timeFrame: 4weeks、12weeks
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Chung Shan Medical University
Study officials:
References: