Science

Levagen+®: Bioavailability Study

A parallel, double-blind, bioavailability study was conducted with 28 healthy male and female volunteers over 18 years old to measure uptake of Levagen®+ (PEA) over a 24-hour period. The objective of this trial was to determine whether the use of a lipid-based drug delivery system, LipiSperse®, can be successfully used to improve the bioavailability of Levagen®.

Study Results:

The results indicate that by combining Levagen with LipiSperse® delivery system, PEA absorption is more effective.

Briskey, D., A. R. Mallard, and A. Rao. "Increased Absorption of Palmitoylethanolamide Using a Novel Dispersion Technology System (LipiSperse®)." J Nutraceuticals Food Sci 5.2 (2020): 3.

Levagen®: Osteoarthritis Study

Double-blinded, randomized, placebo-controlled 8-week study to assess the safety and efficacy of Levagen® on patients with mild to moderate osteoarthritis. The clinical trial studied 120 patients:

(i) Placebo [40]; (ii) Levagen® 300mg/day [40]; and Levagen® 600mg/day [40].

Study Results:

300mg and 600mg Levagen® significantly:

Palmitoylethanolamide is both a powerful anti-inflammatory and pain reliever, providing an all-in-one solution for managing discomfort.*


Steels, Elizabeth. et al. "A double-blind" randomized placebo controlled study assessing safety, tolerability and efficacy of palmitoylethanolamide for symptoms of knee osteoarthritis." Inflammopharmacology 27.3 (2019): 475 - 485

Levagen+®: Exercise Recovery Study

A double-blind, randomised, placebo-controlled study to evaluate the effect of orally dosed Levagen®+ on exercise recovery in 28 healthy males (18-35 years).

72-hour treatment duration with 2 trial arms: (i) Levagen+ 168mg; and (ii) Placebo

30 minutes after ingestion of product, participants were exercised to induce local leg muscle fatigue using a leg press (4 sets of 80% of 1RM). Participants consumed the supplement again post-workout and dosed once daily for three days thereafter.

Two hours post exercise fatigue the participant again completed 1 set of leg press reps at 70% of maximal until exhaustion to measure performance.

Study Results:

Levagen®+ significantly:

The results suggest that Levagen®+ may allow individuals to train harder and longer than placebo by reducing muscle damage and sparing anaerobic energy metabolism. This allows athletes to push past their limits and improve training response.

Mallard, Briskey, Richards, Mills & Rao "The Effect of Orally Dosed Levagen+ (palmitoylethanolamide) on Exercise Recovery in Healthy Males - A Double-Blind, Randomized, Placebo-Controlled Study". Nutrients 12.3 (2020):596

Hydrocurc®: Bioavailability Study

A parallel, double-blind, bioavailability study was conducted with 28 healthy male and female volunteers over 18 years old to measure uptake of Hydrocurc® PEA over a 24-hour period. The objective of this trial was to determine whether the use of a lipid-based drug delivery system, LipiSperse®, can be successfully used to improve the bioavailability of Curcuma longa extract (95% curcuminoids).

Study Results:

These results indicate Hydrocurc® to be the most bioavailable curcumin seen in industry to date with the lowest dose.

Hydrocurc® also had the highest loading of Curcuma longa extract (90%) with the lowest load of excipients (10% Lipisperse®).

Briskey, D., et al. "Increased bioavailability of curcumin using a novel dispersion technology system (LipiSperse®)." European journal of nutrition (2018): 1-11.

Hydrocurc®: Exercise Recovery Study

A double-blind, randomised, placebo-controlled study to evaluate the effect of orally dosed Hydrocurc® on exercise recovery in 28 healthy males (18-35 years).

72-hour treatment duration with 2 trial arms: (i) Hydrocurc® 500mg; and (ii) Placebo.

30 minutes after ingestion of product, participants were exercised to induce local leg muscle fatigue using a leg press (4 sets of 80% of 1RM). Participants consumed the supplement again post-workout and dosed once daily for three days thereafter.

Two hours post exercise fatigue the participant again completed 1 set of leg press reps at 70% of maximal until exhaustion to measure performance.

Study Results:

500mg Hydrocurc® significantly:

  1. Reduced lactate levels
  2. Reduced delayed onset muscle soreness (DOMS) [48- and 72-hours post-exercise]
  3. Increased IL-10 (anti-inflammatory)
  4. Reduced thigh circumference (swelling)
  5. Actives the downstream region of the mTOR pathway (Akt/PKB)

These results suggest that Hydrocurc® may allow for a quicker return to exercise training or ability to exercise higher thresholds. This may be due to an interaction between IL-6 and IL-10 eliciting anti-inflammatory properties which reduce thigh circumference, pain, and modulate energy metabolism.

Activation of mTOR pathway also indicates Hydrocurc® to be a potential stimulator of muscle hypertrophy.

Mallard, Alistair R., et al. "Curcumin improves delayed onset muscle soreness and postexercise lactate accumulation." Journal of Dietary Supplements (2020): 1-12.

Hydrocurc®: Cognitive Health Study

A 6-week double-blind, randomised, placebo-controlled study to study the effects of co-administering oral iron supplementation with HydroCurc® on serum BDNF levels and ferritin levels.


180 healthy adults (18-40 years) across 5 groups:

  1. Curcumin placebo + iron placebo
  2. 18mg elemental iron + curcumin placebo
  3. 18mg elemental iron + 500 mg HydroCurc®
  4. 65mg elemental iron + curcumin placebo
  5. 65mg elemental iron + 500 mg  HydroCurc®

* >50mg iron = pharmaceutical dose

Study Results:

HydroCurc® +18mg Iron group had:

These results indicate that co-administrating HydroCurc® with 18 mg elemental iron for 42 days can significantly increase serum BDNF levels and ferritin levels, which may suggest the ability to enhance cognitive function (memory & learning) and tolerance to iron supplementation.

Tiekou Lorinczova, Helena, et al. "Co-Administration of Iron and a Bioavailable Curcumin Supplement Increases Serum BDNF Levels in Healthy Adults." Antioxidants 9.8 (2020): 645.

Testofen®: Andropause Study

12-week double-blind, randomized, placebo-controlled study to assess the effectiveness of Testofen® on 20 male subjects (aged 40-75) with symptoms of andropause (male menopause).


Participants were given a clinically validated questionnaire (AMS), which was comprised of seventeen questions in three sub-scales (Psychological, Somatic, and Sexual). This questionnaire helped gauge the level of severity of Andropause symptoms. In addition, this study also used the DISF-SR to measure the parameters.

Study Results:

600mg Testofen® significantly:

This study suggests Testofen® to be a safe and effective treatment for reducing symptoms of possible androgen deficiency, improve sexual function and increase serum testosterone in healthy middle-aged and older men.

Rao, Amanda, et al. "Testofen, a specialised Trigonella foenum-graecum seed extract reduces age-related symptoms of androgen decrease, increases testosterone levels and improves sexual function in healthy aging males in a double-blind randomised clinical study." The Aging Male 19.2 (2016): 134-142.

Exercise Performance Study: Body Composition, Strength and Power

An 8-week double-blind, randomized, placebo-controlled study to evaluate the effect of Testofen® on muscle strength, aerobic endurance and body composition in 138 healthy exercising males.

Muscle strength (1RM leg and bench press) and muscular endurance (80% of 1RM bench and leg press until fatigue) were measured.

Body composition and functional threshold power (FTP) were also measured.

Three groups: (i) 600mg Testofen®; (ii) 300mg Testofen®; (iii) Placebo

Study Results:

Dose-dependent improvement in lower body strength across all three groups.

600mg Testofen® significantly:

Testofen® at a 600 mg/day dose in conjunction with an effective exercise regime has superior positive effects in leg strength, aerobic capacity and body composition compared with placebo and a 300 mg/day dose. Testofen® may be an effective ergogenic aid for those wanting to rapidly improve their exercise performance capabilities and body composition above and beyond that of only exercise training.

Rao, Amanda J., Alistair R. Mallard, and Ross Grant. "Testofen®(Fenugreek extract) increases strength and muscle mass

Testofen®: Libido Study

A six-week double-blind, randomized, placebo-controlled clinical study to assess the efficacy of Testofen® on enhancing libido in 60 healthy adult males (aged 25-52).

DISF-SR was administered to measure quality of sexual functioning, along with QOL measures.

Study Results:

600mg Testofen® significantly:

This study suggests that 600mg Testofen® can improve physiological aspects of libido and may assist to maintain normal healthy testosterone levels.

Steels, E., Rao, A. and Vitetta, L., 2011. Physiological Aspects of Male Libido Enhanced by Standardized Trigonella foenum-graecum Extract and Mineral Formulation. Phytotherapy Research, Vol. 25, 1294–1300. doi: 10.1002/ptr.3360

Anabolic Study: Body Composition, Strength & Testosterone

A double-blind, randomized, placebo-controlled human clinical study to assess the efficacy and safety of Testofen® on physiological parameters related to muscle anabolism, androgenic hormones, and body fat in 60 male subjects during an 8-week resistance training program.


Study Results:

600mg Testofen® significantly:

This study suggests Testofen® to provide anabolic and androgenic activity in resistance trained male subjects by improving body fat without a reducing muscle strength or repetitions to failure. Testofen® was also found to be safe and well-tolerated.

Wankhede S, Mohan V, Thakurdesai P, Beneficial effects of fenugreek glycoside supplementation in male subjects during resistance training: a randomized controlled pilot study, Journal of Sport and Health Science (2015), doi: 10.1016/j.jshs.2014.09.005.

affron®: Mood and Sleep Study

affron® the top saffron ingredient worldwide (most researched and studied) balances mood and promotes restorative sleep in healthy adults over 4 weeks in a double-blind, parallel, randomized, placebo controlled clinical trial. First clinical study performed with a commercial saffron extract in healthy people.

The participants, self-reporting low mood, were included, and randomly assigned to groups: (i) affron® 22mg; (ii) affron® 28 mg; (iii) placebo.

Study Results:

28mg/day affron®:

These results indicate affron® to be a safe and effective ingredient to help support mood and sleep. This opens up new horizons in promising natural therapies.

Orio, Laura, et al. "Antianhedonic and Antidepressant Effects of Affron®, a Standardized Saffron (Crocus Sativus L.) Extract." Molecules 25.14 (2020): 3207.

affron®: Bioavailability Study

A single dose, randomized, double blinded study was used to evaluate the bioavailability (of crocins) of two different saffron doses (56 mg and 84 mg).

Study Results:

affron® galenic presentation showed rapid absorption and high oral bioavailability.

Almodóvar, Paula, et al. "Bioaccessibility and Pharmacokinetics of a Commercial Saffron (Crocus sativus L.) Extract." Evidence-Based Complementary and Alternative Medicine 2020 (2020).

affron®: Mood Study

A randomised, double-blind, placebo-controlled study to investigate the efficacy of 28mg/day affron® for encouraging a positive mood, occasional stress, and sleep quality in 128 healthy adults over 4 weeks.

Study Results:

affron®: Restorative Sleep Study

A 4-week randomized, double-blind, placebo-controlled study to examine the sleep-enhancing effects of 28mg/day affron® in 63 adults aged between 18 and 70 years (average age 50 years) with self-reported sleep problems.

Study Results:

Lopresti AL, et al. Effects of Saffron on Sleep Quality in Healthy Adults With Self-Reported Poor Sleep: A Randomized, Double-Blind, Placebo-Controlled Trial. J Clin Sleep Med. 2020 Feb 14:10.5664/jcsm.8376.

Slimaluma®: Weight Management Study

A 60-day, double-blind, randomized placebo-controlled clinical trial to assess the effect of Slimaluma®  on appetite, food intake and body composition in 50 overweight male and females (25-60 years).

Study Results:  

1g Slimaluma® significantly:

There was also trend towards a greater decrease in body weight, body mass index, hip circumference, body fat and energy intake between assessment time points in the experimental group, although not different between experimental and placebo groups.

These results indicate Slimaluma® to suppress appetite, and reduce waist circumference when compared to placebo over a 2 month period.


Kuriyan R, et al., 2007. Effect of Caralluma Fimbriata extract on appetite, food intake and anthropometry in adult Indian men and women. Appetite, 48, 338-344.

Slimaluma®: Metabolic Syndrome Study

A 12-week randomised, placebo-controlled study to assess the effect of Slimaluma® on risk factors of metabolic syndrome in metabolic 43 obese and overweight subjects.

Study Results:  

1g Slimaluma® significantly:

In addition a significant reduction in bodyweight, BMI, hip circumference, systolic BP, HR, triglyceride levels, total fat and saturated fat intake within both groups.

This suggests that supplementing with Slimaluma® whilst controlling overall dietary intake and physical activity may potentially play a role in curbing central obesity, the key component of metabolic syndrome.


Astell, Katie J., et al. A pilot study investigating the effect of Caralluma fimbriata extract on the risk factors of metabolic syndrome in overweight and obese subjects: a randomized controlled clinical trial.

Slimaluma®: Anxiety and Stress Study

An 8-week randomized placebo-controlled clinical trial on the efficacy of Slimaluma® for reducing anxiety and stress in 97 healthy adults with mild-moderate anxiety.

Study Results:  

1g Slimaluma® significantly:

The findings indicate that Slimaluma® is superior to placebo in reducing subclinical anxiety and stress over 8 weeks.

Kell, Graham, A. Rao, and M. Katsikitis. "A randomised placebo controlled clinical trial on the efficacy of Caralluma fimbriata supplement for reducing anxiety and stress in healthy adults over eight weeks." Journal of affective disorders246 (2019): 619-626.

Libifem®: Menopause Study

A 12-week double-blind, randomised, placebo-controlled study to assess the effect of Libifem® in reducing menopausal symptoms in 115 women (aged 40-65).

Primary outcome measure: Reduction in menopausal symptoms (MENQOL).
Secondary outcome measures: Serum sex hormone levels and other quality of life questionnaires – DISF and FSFI (sexual function), PSI (sleep function), and IPAC (physical exercise).

Study Results:  

600mg Libifem® significantly:

The average estradiol levels were similar in both the active group and placebo group after treatment.

This study demonstrated that Libifem® may reduce menopausal symptoms in healthy women.


Steels, E., Steele, M.L., Harold, M. and Coulson, S., 2017. Efficacy of a proprietary Trigonella foenum‐graecum L. de‐husked seed extract in reducing menopausal symptoms in otherwise healthy women: a double‐blind, randomized, placebo‐controlled study. Phytotherapy Research, 31(9), pp.1316-1322.

Libifem®: Sexual Health Study

An 8-week double-blind, randomised, placebo-controlled study to evaluate the effect of Libifem® on sex hormones and sexual function in 80 healthy menstruating women (aged 20-49) who reported low sexual drive.


Sexual function was measured using the DISF-SR standard, which tests five domains of sexual function.

Study Results:  

600mg Libifem® significantly:

The results indicate that Libifem® may be auseful treatment for increasing sexual arousal and desire in women.


Rao, Amanda, et al. "Influence of a specialized Trigonella foenum‐graecum seed extract (libifem), on testosterone, estradiol and sexual function in healthy menstruating women, a randomised placebo controlled study." Phytotherapy Research 29.8 (2015): 1123-1130.

Genopause®: Menopause Study

A 12-week double-blind, randomized, placebo-controlled trial to examine the safety and efficacy of Genopause® in reducing vasomotor and other menopause-associated symptoms in 117 healthy women (aged 40-65).

Study results:

1g Genopause® significantly:

There were no significant changes observed in serum hormone levels or health indices between the active and the placebo group.

This study demonstrated Genopause® to be a safe and effective treatment for reducing menopausal symptoms in healthy menopausal women over a duration of 12 weeks.

Steels, Elizabeth, et al. "A double-blind, randomized, placebo-controlled trial evaluating safety and efficacy of an ayurvedic botanical formulation in reducing menopausal symptoms in otherwise healthy women." Journal of Herbal Medicine 11 (2018): 30-35.

AGEprost®: Benign Prostatic Hyperplasia Study

A 12-week double‐blind, randomized, placebo‐controlled clinical trial assessed the efficacy and safety of AGEprost® in treating 109 men (aged 41-79) with benign prostatic hypertrophy (BPH).

Study Results:

250mg AGEprost® significantly:

Overall, steroid hormones, SHBG, PSA levels, DHEA and Cortisol remained within the healthy reference range in both groups and remained stable over the 12 weeks. There were no changes in associated age-related symptoms and sexual function in either group. Treatment was well tolerated and there were no serious adverse effects observed during the study period.

The overall results indicate that AGEprost® may be an effective treatment for reducing symptoms of BPH in healthy men, in part, through inhibition of 5‐alpha‐reductase enzyme activity.


Detering, Matthew, et al. "Ageratum conyzoides L. inhibits 5‐alpha‐reductase gene expression in human prostate cells and reduces symptoms of benign prostatic hypertrophy in otherwise healthy men in a double blind randomized placebo controlled clinical study." BioFactors 43.6 (2017): 789-800.APA


Tesnor® : Young Male Testosterone Study

A randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of a novel herbal composition in improving testosterone levels in 120 healthy young males (aged 21-35) over the course of 56-days.

Three groups: (i) 200mg Tesnor™; (ii) 400mg Tesnor™; (iii) Placebo.

Study Results:

200mg and 400mg Tesnor®  significantly:

These results indicate that Tesnor® helps to maintain an elevated level of testosterone in circulation by lowering the coritsol level and reducing the metabolic conversion of testosterone to estradiol.

This study demonstrates that supplementing with Tesnor® for 56 days significantly improves free and total testosterone levels in serum of young male subjects with no significant changes in vital signs, hematological, and biochemical parameters. Concurrently, those who supplemented with Tesnor® showed improvement in their hormonal profiles and muscle parameters. Overall, the participants well-tolerated the study supplement during the study.


Tesnor® : Ageing Male Testosterone Study

A randomized, double blind, placebo controlled study to evaluate the efficacy and safety of a novel herbal composition improving aging males symptoms in 120 healthy males (aged 36-55) over the course of 56-days.

Three groups: (i) 200mg Tesnor® ; (ii) 400mg Tesnor™; (iii) Placebo.

Study Results:

200mg and 400mg Tesnor®  significantly:

These results indicate that supplementing with Tesnor® can be a promising strategy to improve aging male symptoms, psychological wellbeing, sexual behavior, and muscle strength in males.

Weight Management Study: Body Composition and Metabolism

A 12-week randomized, double-blind, placebo-controlled study to asses the effect of ActivAMP® on 80 overweight participants.

Study Results:

450mg ActivAMP® significantly:

This study revealed that Gynostemma pentaphyllum is a potent antiobesity reagent that does not produce any significant adverse effects. These results suggest that supplementing with G. penyaphyllum may be effective for treating obese individuals.

Park, S. "Antiobesity effect of Gynostemma pentaphyllum extract: A randomized, double-blind, placebo-controlled trial." Biotechnology Letters, DOI: 10.1007/s10529-012-0944 1 (2013).

Gencinia®: Blood Glucose Study

A 60-day double-blind, placebo-controlled, randomised trial to assess the efficacy and safety of Coccinia indica in 60 incident type 2 diabetic subjects (aged 35-60).

Study Results:

1g Gencinia® significantly:

This study suggests that Coccinia cordifolia extract has a potential hypoglycemic action in patients with mild diabetes.

Kuriyan R, et al. 2008. Effect of supplementation of Coccinia Cordifolia extract on newly detected diabetic patients. Diabetes Care, vol. 31, 216−220.

Study results for a clinical trial at University of Sunshine Coast, Queensland, Australia

An eight-week double-blind, randomized placebo controlled clinical trial was conducted using CALMaluma™ on 97 patients (49 in the active group and 48 in the placebo group).

Study Results:

The study showed statistically significant results in the active group when compared to the placebo for:

Citation: G. Kell., et al., 2019. A randomised placebo controlled clinical trial on the efficacy of Caralluma fimbriata supplement for reducing anxiety and stress in healthy adults over eight weeks. Journal of Affective Disorders, 246, 2019, 619-626.

Study results for Nootropic effects:

An in-vivo animal study showed CALMaluma™ also facilitates learning and supports memory function. The study also revealed a reduction in anxiousness in test animals. CALMaluma™ therefore exhibited both Nootropic and Anxiolytic activity in animal models.

Citation: Rajendran R., et al., 2014. Nootropic activity of Caralluma fimbriata extract in mice. Food and Nutrition sciences, 2014, 5, 147-152.

In Vitro Study 1

Effect of A. conyzoides on 5α-reductase gene expression in Human Hair Dermal Papilla Cells (HHDPC) after 48h treatment.

Study Results:

After 48 hours of treatment, there was a significant reduction (3-fold reduction) in 5α-reductase type 1 mRNA expression in the 0.1 mg A. conyzoides group compared to negative control. 


In Vitro Study 2

Effect of A. conyzoides on inhibition of PGD2 production in Human Hair Dermal Papilla Cells (HHDPC) after 6 h treatment 

Study Results:

After 6 hours of treatment, there was a significant inhibition of PGD2 release in HHDPC in A. conyzoides groups compared to negative control.



Mechanism of Action:

A. Conyzoides inhibits 5α-reductase → prevents conversion of testosterone to DHT → improved hair growth and decreased hair loss 

A. Conyzoides inhibits PGD2 → improved hair growth and decreased hair loss 

Open Label Study


Study Results:

Temporal recession in men reduced: 

Study Results:

In Men:


There was a dose-dependent increase in proportion of participants who: 

Study Results:

In Women: 

The majority of participants: 

All participants self-reported an improvement in their hair loss symptoms 

HairAge Vitae Effectiveness:

Efficacy of a Topical Application of Ageratum Conyzoides

Study Results:

Our study found a significant increase in hair density and significant decrease in HLR following topical application of A. conyzoides. At 12-weeks, hair density in the A. conyzoides treated group was significantly higher and HLR was significantly lower than the placebo group. No significant changes were found in the one-minute combing test or hair pull test or assessment by the Hamilton-Norwood and Savin hair loss scales. QoL measures and biochemical and haematological parameters showed no significant changes throughout the study.

Conclusion:

The results from our study demonstrate a net increase in hair growth following topical application of A. conyzoides.

Liver Study

Randomized, Double-blind, Placebo and Active comparator-controlled study, to evaluate the efficacy of a novel herbal composition to improve Liver function and well-being of non-alcoholic subjects with elevated Fatty Liver Index.

Methodology:

Test materials:

Dosage:

One capsule of 300 mg 4Liver (CL16049F1) per day after dinner, 320 mg active comparator, or placebo for 12 weeks. 

Results:

* These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.