Can you summarize any available data on the safety/efficacy of the supplement SeroVital Advanced (anti-aging supplement)?

Comment by InpharmD Researcher

Evidence on the safety and efficacy of the supplement SeroVital Advanced is sparse. Available studies are limited by a number of factors, including small sample sizes, poor study designs, and varying indirect treatment outcomes. No major safety issues were identified in the literature, however, there is overall limited safety data reported. The evidence shows SeroVital is able to raise human growth hormone levels up to 2 hours after administration; however, a sustained effect has not been proven and there is also no established link between raising/maintaining hGH levels and senescence.

Background

A 2021 review summarized three studies that evaluated the mechanism for the increase in human growth hormone (hGH) and the effect of daily administration of an oral supplement (SeroVital) on physical fitness and sleep efficiency. [1]

The first study was a post-hoc analysis of a randomized, placebo-controlled, double-blind, crossover study (n= 16) in which healthy participants received both placebo and the oral test supplement; serum triiodothyronine (T3) was measured to assess if the test supplement stimulates hGH release by inhibition of somatostatin, which is an established mechanism by which certain amino acids can stimulate hGH release. T3 levels are reduced by somatostatin by inhibition of thyroid-stimulating hormone secretion. There was not a statistically significant change in T3 levels with the test supplement compared to placebo (mean -3.3 ± 10.7 ng/dL [3% change from baseline); 95% confidence interval [CI] -9.0 to 2.4 vs. -6.1 ± 8.5 ng/dL [6% change from baseline]; 95% CI -10.6 to -1.5). Of note, this was a secondary analysis of a study (see Table 1), and therefore was not powered to detect a statistically significant change in T3 between the two groups. [1]

The second study (n =12) evaluated physical fitness (VO2 max) at baseline and after two weeks of daily administration of the test supplement in healthy participants. A statistically significant increase in mean VO2 max from baseline to the end of the study (14 days) was found (mean 2.7 ± 1.0 mL/kg/min; 6% increase from baseline; 95% CI 0.5 to 5.0; p= 0.02). [1]

The third study (n= 15) evaluated daily sleep onset latency and time awake during three weeks of administration of the supplement daily in healthy participants. Sleep-onset latency was reduced at week 3 from baseline by 22%, while time awake during the night was reduced by 65% (p= 0.01 and p=0.02, respectively). [1]

The review concluded that these results indicate the test supplement enhances hGH release through the inhibition of somatostatin. Furthermore, repeated treatment with the test supplement for up to three weeks was associated with an improvement in physical fitness (VO2 max) and a self-reported improvement in sleep efficiency, results that are consistent with increased hGH release. All studies were limited by small sample sizes; the second and third studies both lack either a placebo or active control. Additionally, a standard questionnaire to assess sleep outcomes was not utilized in the third study. The results of these studies should be interpreted with caution, given the aforementioned limitations of the studies. [1]

References:

[1] Heaton AL, Kelly C, Rood J, Tam CS, Greenway FL. Mechanism for the Increase in Human Growth Hormone with Administration of a Novel Test Supplement and Results Indicating Improved Physical Fitness and Sleep Efficiency. J Med Food. 2021;24(6):653-659. doi:10.1089/jmf.2020.0109
Literature Review

A search of the published medical literature revealed 1 study investigating the researchable question:

Can you summarize any available data on the safety/efficacy of the supplement SeroVital Advanced (anti-aging supplement)?

Level of evidence

C - Multiple studies with limitations or conflicting results  Read more→


Please see Table 1 for your response.

 

Increased human growth hormone following oral consumption of an amino acid supplement: results of a randomized, placebo-controlled, double-blind, crossover study in healthy subjects

Design

Randomized, double-blind, placebo-controlled, crossover study

N= 16

Objective

To test the effects of a novel blend of amino acids (SeroVital®) optimized to increase human growth hormone (hGH) release

Study Groups

SeroVital (n= 16)

Placebo (n= 16)

Inclusion Criteria

Healthy males and females aged between 18-70 years

Exclusion Criteria

 Pregnant or nursing; taking any chronic medications (including birth control)

Methods

Participants reported to an inpatient unit after an overnight fast. They were randomized to receive an oral dose of SeroVital or placebo. After completing the visit, participants had a 1-week washout before returning to receive the opposite treatment.

During both visits, participants had their blood drawn 15 and 30 minutes before study drug administration, at study drug administration, and at 15, 30, 60, 90, and 120 minutes after study drug administration.

Duration

 120 minutes

Outcome Measures

Primary: change in hGH from baseline to 120 minutes

Secondary: area under the curve (AUC) of hGH (0 to 120 minutes) over baseline

Baseline Characteristics

  

All patients (N= 16)

    

Age, years (range)

 23 ± 14 (18-62)    

Male

 75%    

Race

Caucasian

African American

Other

 

56%

38%

6%

    

Body mass index, kg/m2 (range)

 26.4 ± 5.0 (19.1-36.8)    

Results

  

SeroVital (n= 16)

 Placebo (n= 16) p-value

hGH levels, ng/mL

Baseline

After 120 minutes

Change after 120 minutes (95% CI)

 

0.17

1.33

1.15 (0.17 to 2.14)

 

0.93

0.45

-0.48 (-1.47 to 0.50)

 0.01

AUC0-120min (95% CI)

 20.43 (19.90 to 20.95) 19.67 (18.74 to 20.59) 0.04

Adverse Events

One patient (6%) reported nausea and lightheadedness during SeroVital administration.

Study Author Conclusions

These results show that a single dose of the oral amino acid supplement (SeroVital) was sufficient to significantly increase hGH levels in healthy adult males and females.

InpharmD Researcher Critique

This study relied solely on surrogate endpoints that have not been clinically correlated. The dose of SeroVital increased hGH levels starting around 50 minutes post-dose, and the levels appeared to peak around 100 minutes post-dose before dropping. Based on this study, the results cannot be extrapolated beyond 2 hours, as the effect does not appear to be sustained.

Additionally, the cohort of patients was small and young, which is not necessarily representative of the population that the study drug is marketed. Only mean results were reported without a standard deviation; with such a small sample size and attributes of the baseline characteristics, a median and interquartile range would give a more meaningful representation of the results. 



References:

Tam CS, Johnson WD, Rood J, Heaton AL, Greenway FL. Increased Human Growth Hormone After Oral Consumption of an Amino Acid Supplement: Results of a Randomized, Placebo-Controlled, Double-Blind, Crossover Study in Healthy Subjects. Am J Ther. 2020;27(4):e333-e337. doi:10.1097/MJT.0000000000000893