- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07552675
Effects of Astragalus Membranaceus on Muscle Function (AD ASTRA)
Astragalus Membranaceus Modulates Inflammatory Markers Without Enhancing Muscle Function Following Intensified Resistance Training
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background and Rationale Physical inactivity is associated with approximately 10% of premature deaths and an estimated €100 billion in annual healthcare costs. Current guidelines recommend at least 150 minutes of moderate-intensity aerobic activity per week alongside resistance training for optimal health. However, when the balance between training load and recovery is disturbed, athletes may develop non-functional overreaching (NFOR), a state of maladaptation characterized by adverse physiological, psychological, and functional outcomes requiring days to weeks for full resolution.
Astragali radix (Astragalus membranaceus), belonging to the Fabaceae family and officially included in the European Pharmacopoeia (8th ed.), is a traditional Chinese herbal medicine known for its antioxidant, anti-inflammatory, and immunomodulatory properties. Prior research has suggested potential benefits in reducing post-exercise inflammatory markers and improving aerobic performance, but its effects during prolonged, structured resistance training programs had not been systematically investigated.
Study Design This was a randomized, double-blind, placebo-controlled trial with 1:1 allocation. Twenty-four moderately active healthy young adults (mean age ~25 years; 13 males/11 females across groups) were enrolled after initial screening of 72 volunteers. Participants were randomly allocated to the ASTRA group (n=13) or PLA group (n=11). Randomization was performed using a computer-generated sequence.
Interventions Participants in the ASTRA group received 480 mg/day of Astragali radix hydroalcoholic extract (Axtragyl®, Giellepi S.p.A., Seregno, Italy; 2 capsules × 240 mg/day) for 10 weeks. The PLA group received matched capsules containing inert substances (microcrystalline cellulose, maltodextrin, magnesium salts of fatty acids) for the same period. Supplement compliance was monitored via daily text messages and collection of returned empty containers.
Training Protocol All participants performed a combined training intervention consisting of: (1) 8 weeks of regular resistance training (RT) at 3 sessions/week, with progressive overload targeting lower limb muscles (back squat, leg press, single-leg extension, single-leg curl, calf raises) at 70-80% of 1RM; followed by (2) 2 weeks of intensified training (IT) at 6 sessions/week, performing 10 sets of 1 repetition at 100% 1RM of leg press and leg extension. All sessions were supervised by experienced personnel.
Assessments
Testing was performed at three time points: baseline (BAS, one week before intervention), after 8 weeks of RT (48 hours post-last session), and after IT completion (24 hours post-last session). Assessments included:
Maximal voluntary isometric torque (MVIT) of knee extensors measured on a custom-built ergometer (primary outcome)
1RM of leg press and leg extension Knee range of motion (ROM) assessed by gyroscope-based goniometry during passive movement Muscle soreness via 100-mm visual analogue scale (VAS) Blood biomarkers: serum CPK, LDH, myoglobin, CRP, IL-6, TNF-α, IGF-1, cortisol, and testosterone (venous blood drawn at BAS, RT, and IT under standardized fasting conditions) Statistical Analysis A general linear model for repeated measures was used, with time (BAS, RT, IT) as within-subject factor and supplementation group (ASTRA vs. PLA) as between-subject factor. Post-hoc comparisons used Bonferroni correction. Effect sizes were reported as partial eta squared (η²). Statistical significance was set at p < 0.05.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Pavia, Italy, 27100
- Università di Pavia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Physical Activity Status: Moderately active, defined as a metabolic equivalent (MET) between 3 and 6 based on the International Physical Activity Questionnaire - Short Form (IPAQ-SF) (Bull et al., 2020).
- Health Status: Non-smokers and free from cardiovascular, metabolic, and neurological diseases.
Exclusion Criteria:
- Injuries: any muscular, bone, or joint injuries sustained within the 6 months prior to the study.
- Supplementation/Medication: A history of consuming dietary supplements or drugs within the 6 months preceding the intervention.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: PLACEBO
|
Capsules containing an inert substance identical by visual, taste, and smell to the active formulation but without any active ingredients
|
|
Experimental: ASTRA
|
480 mg daily of astragali radix extract for 10 weeks (2 capsules x day orally).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
MVIT
Time Frame: One week before the start of the intervention (BAS), 48 hours after RT phase, and 24 hours following the completion of IT phase.
|
Maximal voluntary isometric torque
|
One week before the start of the intervention (BAS), 48 hours after RT phase, and 24 hours following the completion of IT phase.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ROM
Time Frame: One week before the start of the intervention (BAS), 48 hours after RT phase, and 24 hours following the completion of IT phase
|
Range of Motion
|
One week before the start of the intervention (BAS), 48 hours after RT phase, and 24 hours following the completion of IT phase
|
|
Muscle soreness
Time Frame: One week before the start of the intervention (BAS), 48 hours after RT phase, and 24 hours following the completion of IT phase.
|
Subjects were asked to mark their pain level on the line under the supervision of the examiner while the knee joint was passively flexed and extended by the investigator.
|
One week before the start of the intervention (BAS), 48 hours after RT phase, and 24 hours following the completion of IT phase.
|
|
Serum Creatine Phosphokinase
Time Frame: One week before the start of the intervention (BAS), 48 hours after RT phase, and 24 hours following the completion of IT phase.
|
Serum Creatine Phosphokinase
|
One week before the start of the intervention (BAS), 48 hours after RT phase, and 24 hours following the completion of IT phase.
|
|
Interleukin-6 (IL-6)
Time Frame: One week before the start of the intervention (BAS), 48 hours after RT phase, and 24 hours following the completion of IT phase.
|
Interleukin-6 (IL-6)
|
One week before the start of the intervention (BAS), 48 hours after RT phase, and 24 hours following the completion of IT phase.
|
|
Tumor necrosis factor-alpha (TNF-α)
Time Frame: One week before the start of the intervention (BAS), 48 hours after RT phase, and 24 hours following the completion of IT phase.
|
Tumor necrosis factor-alpha (TNF-α)
|
One week before the start of the intervention (BAS), 48 hours after RT phase, and 24 hours following the completion of IT phase.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UNIPV0040463/23
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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